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The purpose of this trial is to compare the progression free survival of LY2510924 + carboplatin + etoposide therapy versus carboplatin + etoposide therapy in patients with extensive-stage disease small cell lung cancer (SCLC)

The study included subjects diagnosed for the first time with HCC, with Child-Pugh score 5-7 points. Subjects to be enrolled will have completed surgical resection or local ablation with curative intent as first treatment for HCC. Subjects will take 2 tablets of sorafenib (200 mg tablets x 2) orally twice daily (BID) or placebo. For more details, please see study protocol.

This study was conducted to evaluate the efficacy and safety of sorafenib in combination with gemcitabine and cisplatin versus placebo with gemcitabine and cisplatin, as the first-line treatment of patients with stage IIIB (with effusion) or Stage IV NSCLC, with ECOG performance status 0 or 1. Patients must have measurable disease and must not have received prior systemic anticancer therapy. Patients received up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib, or placebo. Day 1: gemcitabine 1250 mg/m2 infusion (IV), followed by cisplatin 75 mg/ m2 IV; Day 8: gemcitabine 1250 mg/m2 IV; Days 1-21: sorafenib 2 tablets (200 mg x 2) taken orally twice daily (BID), or placebo.

This study was conducted to evaluate safety and efficacy of carboplatin and paclitaxel in combination with sorafenib versus placebo, in chemo-naive patients with unresectable stage IIIB (with pleural or pericardial effusion) or Stage IV non-small cell lung cancer. Patients received chemotherapy up to 6 cycles: Sorafenib 400 mg orally, twice daily (or placebo) on Study Days 2-19 and paclitaxel (P) (200 mg/m2, IV) and carboplatin (C) (AUC = 6 mg/ml*min-1, IV) on Study Day 1. The cycle duration is 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily (or placebo) was administered on Days 1-21 of each 21-day cycle.

This study was conducted to evaluate efficacy and safety of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapies. Regorafenib (Stivarga, BAY73-4506) was given at160 mg per oral once daily for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off). Best Supportive Care (BSC) includes any concomitant medications or treatments except other investigational anti-tumor agents or anti-neoplastic chemo/hormonal/immuno-therapy.

This multinational, randomized, multicenter, open-label, Phase 3 study was to enroll approximately 1080 patients with histologically or cytologically confirmed Stage IV squamous NSCLC. Patients were randomized on a 1:1 basis to the GC+N Arm or the GC Arm. Randomization was stratified by ECOG PS (0-1 vs. 2) and geographic region (North America, Europe, and Australia vs. South America, South Africa, and India vs. Eastern Asia). Patients in the GC+N Arm received the following: -Necitumumab: 800 mg (absolute dose, intravenous [I.V.]) on Days 1 and 8 of each 3 week cycle -Gemcitabine: 1250 mg/m2 (I.V.) on Days 1 and 8 of each 3-week cycle (maximum of 6 cycles) -Cisplatin: 75 mg/m2 (I.V.) on Day 1 of each 3-week cycle (maximum of 6 cycles) Patients in the GC Arm received: -Gemcitabine: 1250 mg/m2 (I.V.) on Days 1 and 8 of each 3-week cycle (maximum of 6 cycles) -Cisplatin: 75 mg/m2 (I.V.) on Day 1 of each 3-week cycle (maximum of 6 cycles) Patients in the GC+N Arm received necitumumab in combination with gemcitabine and cisplatin chemotherapy for a maximum of 6 cycles, or until there was radiographic documentation of progressive disease (PD), toxicity requiring cessation, protocol noncompliance, or withdrawal of consent. Patients in the GC Arm continued to receive gemcitabine and cisplatin chemotherapy for a maximum of 6 cycles, or until there was radiographic documentation of PD, toxicity requiring cessation, protocol noncompliance, or withdrawal of consent.

The purpose of this study is to determine the treatment effect of Panitumumab in combination with chemotherapy versus chemotherapy alone as first line therapy for metastatic and/or recurrent squamous cell carcinoma of the head and neck.

The purpose of this study is to determine the treatment effect of panitumumab in combination with FOLFOX compared to FOLFOX alone as first line therapy for metastatic colorectal cancer

The purpose of this study is to evaluate the treatment effect of panitumumab plus FOLFIRI compared to FOLFIRI alone as second line therapy for metastatic colorectal cancer.

The purpose of this study is to assess whether treatment with the study drug, panitumumab given concomitantly with every 2 (Q2) week oxaliplatin-based chemotherapy and bevacizumab improves progression-free survival (PFS) compared to treatment Q2-week with oxaliplatin-based chemotherapy and bevacizumab alone. All subjects will receive Q2-week oxaliplatin- or irinotecan-based chemotherapy and bevacizumab. Control arm subjects will not receive concomitant panitumumab therapy.

The purpose of this study is to evaluate whether increasing or maintaining hemoglobin concentrations with darbepoetin alfa, when administered with platinum-containing chemotherapy in subjects with previously untreated extensive-stage small cell lung cancer (SCLC), increases survival.

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether cisplatin, etoposide, and paclitaxel are more effective than cisplatin and etoposide alone in treating patients with extensive-stage small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus etoposide with or without paclitaxel in treating patients with extensive-stage small cell lung cancer.

With the exception of patients with localised liver metastases that can be resected, the median survival time for patients with metastatic CRC is less than 2 years. There is, therefore, a need to develop novel treatment regimens to improve survival in these patients.This study will demonstrate whether small molecule inhibition of VEGF receptor signaling is a superior anti-angiogenic approach to monoclonal antibody binding of VEGF by comparing the combination of cediranib plus FOLFOX to bevacizumab plus FOLFOX.

To determine if ZD6474 a new investigational drug, is effective in treating Non Small Lung Cancer and if so, how it compares with another type of anti-cancer therapy chemotherapy, Erlotinib

Study 21004 was a randomized, double-blind, multicenter, phase 3 study evaluating orteronel plus prednisone compared with placebo plus prednisone in the treatment of men with progressive, chemotherapy naive, metastatic, castration-resistant prostate cancer (mCRPC). Patients in the 2 treatment groups received blinded study drug (orteronel or placebo) twice daily through the study in addition to open-label prednisone and gonadotropin-releasing hormone (GnRH) analogue therapy. Patients who had undergone orchiectomy and had a testosterone concentration of <50 ng/dL could have participated in the study without prior or ongoing concomitant GnRH analogue treatment. One formal interim analysis was planned for this study after approximately 412 radiographic disease progression events were observed. The final analysis was to be conducted after approximately 600 overall survival (OS) events occurred. If the study met at least 1 of the co-primary endpoints at the final analysis, patients who were receiving placebo were allowed to cross over to orteronel treatment. The study was expected to last approximately 45 months until reaching the final analysis of the OS endpoint. Patients were followed for survival until 80% of patients died or were lost to follow-up. Randomization was in a 1:1 ratio, stratified by region (North America [US and Canada], Europe, and rest of world) and radiographic disease progression at baseline (Yes/No).

This dataset was part of the training data curated for the Prostate Cancer DREAM Challenge. To view the curated training dataset, which includes 3 mCRPC datasets from ProjectDataSphere.org, visit: https://www.projectdatasphere.org/projectdatasphere/html/content/149

This dataset was included in the Prostate Cancer Tumor Growth data cited in The Lancet Oncology manuscript: Estimation of tumour regression and growth rates during treatment in patients with advanced prostate cancer. To view the consolidated Prostate Cancer Tumor Growth data, visit: https://www.projectdatasphere.org/projectdatasphere/html/content/167

This is a phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel-group efficacy and safety study in chemo-naive subjects with metastatic castrate-resistant prostate cancer (CRPC) with documented progressive disease as determined by rising PSA levels or radiological progression following hormone therapy. Subjects meeting the exclusion criteria will be randomized 1:1 into one of two treatment arms: -DP Treatment Arm: docetaxel, prednisone, and placebo -DPL Treatment Arm: docetaxel, prednisone, and lenalidomide Note: For purposes of this study, PSA progression is not considered disease progression and does not mandate discontinuation from the Treatment Phase of the study. Subjects experiencing treatment related-toxicity will be allowed to dose reduce or discontinue either docetaxel or lenalidomide while remaining eligible to continue study treatment with the remaining drug. Complete discontinuation of both drugs will result in discontinuation of study treatment. All subjects will be contacted 28 days after the last dose for adverse events (AEs) and concomitant medications and then followed for survival and post-study prostate cancer treatments every 90 days until death or up to 5 years following treatment phase discontinuation. Efficacy and safety assessments to be performed during the study are detailed in Protocol Table 2: Schedule of Study Assessments.

Study MMY-3002 was a randomized, open-label, multicenter study to compare the efficacy and safety of Vc-MP therapy against MP therapy in subjects with previously untreated multiple myeloma who were not candidates for HDT/SCT. Subjects were randomly assigned to 1 of 2 treatment groups (Vc-MP or MP) and were stratified according to baseline beta2-microglobulin, baseline albumin levels, and region (North America, Europe, Other). Subjects in the Vc-MP treatment group received VELCADE 1.3 mg/m2 (twice weekly [Weeks 1, 2, 4, and 5] for four 6-week cycles [8 doses per cycle] followed by weekly [Weeks 1, 2, 4, and 5] for five 6-week cycles [4 doses per cycle]) in combination with melphalan 9 mg/m2 and prednisone 60 mg/m2 (once daily on Days 1 to 4 of each 6-week cycle). Subjects in the MP treatment group received 9 cycles of melphalan 9 mg/m2 and prednisone 60 mg/m2 once daily on Days 1 to 4 of each 6-week cycle. For both groups, treatment continued for a maximum of 9 cycles (54 weeks) and was discontinued if progressive disease (PD) or unacceptable treatment-related toxicity occurred, or if a subject withdrew consent. The study consisted of 3 phases: a Pre-randomization (screening) Phase, an Open-label Treatment Phase, and a Post-treatment Follow-up Phase. Throughout the Open-label Treatment and Post-treatment Follow-up Phases, the investigator assessed the subject's response to therapy using the results of efficacy evaluations conducted at equivalent frequency (every 3 weeks in the first 54 weeks and every 8 weeks thereafter) in each treatment group and by applying protocol defined disease-response criteria (EBMT criteria). In the Post-treatment Follow-up Phase, subjects were followed until death or a maximum of 4.5 years after the last subject was randomized on the study.

This was a multi-center, international, randomized, open-label study designed to determine whether VELCADE provided benefit to patients with relapsed or refractory multiple myeloma relative to treatment with high-dose dexamethasone. This study also was designed to determine the safety and tolerability of VELCADE relative to high-dose dexamethasone. Patients were to be assigned to receive VELCADE or high-dose dexamethasone by random allocation at a 1:1 ratio. Randomization was to be stratified based on 3 factors: the number of lines of prior therapy (one prior line versus more than one prior line of therapy), time of progression relative to last prior therapy (progression while on the most recent therapy or within 6 months of stopping versus relapse >6 months after receiving the most recent therapy) and screening beta2-microglobulin levels (>2.5 mg/L versus <=2.5 mg/L). Patients were to be evaluated at scheduled visits in up to 4 study periods, Pre-Treatment, Treatment, Short-Term Follow-Up, and Long-Term Follow-Up. The Pre-Treatment Period included Screening and Baseline visits. After providing written informed consent to participate in the study, patients were to be evaluated for study eligibility during the Screening period. Eligible patients were to be enrolled in the study and randomly assigned to treatment with VELCADE or dexamethasone via an Interactive Voice Response System (IVRS) system. Day 1 of Cycle 1 was to occur within 72 hours after randomization. All patients who permanently discontinued study drug, whether prematurely or as scheduled were to complete the End of Treatment visit a minimum of 30 days after the last study drug dose. Patients who discontinued study drug for reasons other than confirmed progressive disease (PD) were to continue attending scheduled study center visits on an every 3-week basis until Week 39 or development of confirmed PD, as determined by the (EBMT) criteria.

A multi-center phase III randomized, double-blind placebo-controlled study in subjects with unresectable stage III NSCLC who have demonstrated either stable disease or objective response following primary chemo-radiotherapy (concomitant or sequential). Subjects will be randomized 2:1 either to L-BLP25 drug product (hereinafter "L-BLP25") (investigational arm) or to L-BLP25 placebo (hereinafter "placebo"), respectively. Subjects were stratified by Disease stage (IIIA versus IIIB), Response to primary chemo-radiotherapy (stable disease versus objective response), Type of primary chemo-radiotherapy (concomitant versus sequential) and Region (1: North America and Australia, 2: Western Europe, or 3: Rest of World).

Subjects were randomized 2:1 to receive either radium-223 dichloride or placebo study treatment using 3 binary variables for stratification: total ALP < 220 U/L versus total ALP ? 220 U/L; current use of bisphosphonates: yes versus no; and any prior use of docetaxel: yes versus no. Subjects received either radium-223 dichloride 50 kBq/kg b.w. or placebo (normal saline), plus BSoC. Subjects received 6 administrations of either radium-223 dichloride or placebo every 4 weeks. Subjects participated in 2 study periods: Treatment period: The treatment period was defined as the time from first injection of study drug, to 4 weeks after last injection of study drug, normally 24 weeks. Follow-up period: The follow-up period was defined as the time from 4 weeks after last administration of study drug until 3 years from first administration.

This was a randomized, open-label, active-controlled, parallel-group, multicenter study that evaluated the safety and efficacy of trabectedin as compared with dacarbazine in subjects 15 years of age and older with unresectable, locally advanced or metastatic L-sarcoma, who were previously treated (in any order) with at least an anthracycline and ifosfamide containing regimen or an anthracycline containing regimen and 1 additional cytotoxic chemotherapy regimen. Approximately 570 subjects who satisfy all inclusion and exclusion criteria will be randomly assigned in a 2:1 ratio to either the trabectedin (n?380) or dacarbazine (n?190) treatment groups. Before randomization, subjects will be stratified by the number of lines of prior chemotherapy (1 versus 2 or more), Eastern Cooperative Oncology Group (ECOG) performance Status score (0 versus 1), and L-sarcoma subtype (liposarcoma versus leiomyosarcoma). Radiographic assessment of disease, using the same radiographic technique, was to include radiographic imaging of the chest (with lung views), abdomen and pelvis. Assessment of disease was to be performed every 6 weeks for the first 36 weeks on study and every 9 weeks thereafter, until disease progression occurred, the subject began subsequent anticancer therapy, the study ended, or the subject died. Subsequent therapy was only to be started after disease progression was documented, when possible. Subjects were to be followed for the collection of survival status and the use of subsequent anticancer therapy every 60 days for the first 2 years after the last dose of study drug, and then every 90 days thereafter. Collection of survival status was to continue until approximately 376 deaths were observed (ie, the final analysis clinical cutoff). Safety assessments were to be based on reported adverse events, clinical laboratory, electrocardiograms and MUGA scans (or echocardiograms if MUGA was not available).

Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PSC 833 may increase the effectiveness of chemotherapy by making cancer cells more sensitive to the drugs. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. This randomized phase III trial is studying giving combination chemotherapy together with PSC 833 followed by a peripheral stem cell transplant with or without interleukin-2 to see how well it works compared to combination chemotherapy alone followed by a peripheral stem cell transplant with or without interleukin-2 in treating patients with acute myeloid leukemia.

RATIONALE: Biological therapies, such as interferon alfa-2b, may interfere with the growth of tumor cells. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. It is not yet known whether interferon alfa-2b is more effective with or without bevacizumab in treating advanced renal cell carcinoma (kidney cancer). PURPOSE: This randomized phase III trial is studying interferon alfa-2b and bevacizumab to see how well they work compared to interferon alfa-2b alone in treating patients with advanced renal cell carcinoma.

This partially randomized phase I/II trial studies the side effects and best dose of sunitinib malate and to see how well it works when given together with cisplatin or carboplatin and etoposide in treating patients with extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether cisplatin or carboplatin and etoposide are more effective when given with or without sunitinib malate in treating small cell lung cancer.

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane, letrozole, or anastrozole, may fight breast cancer by lowering the amount of estrogen the body makes. Giving exemestane, letrozole, or anastrozole before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether exemestane, letrozole, or anastrozole is more effective in treating breast cancer. PURPOSE: This randomized phase III trial is studying exemestane, letrozole, and anastrozole to compare how well they work in treating postmenopausal women who are undergoing surgery for stage II or stage III breast cancer.

RATIONALE: Zoledronate may prevent or decrease skeletal (bone)-related events (such as pain or fractures) caused by bone metastases and androgen deprivation therapy. It is not yet known whether treatment with zoledronate is effective in preventing bone-related events in patients who have prostate cancer and bone metastases. PURPOSE: This randomized phase III trial is studying how well zoledronate works in preventing bone-related events in patients who are receiving androgen deprivation therapy for prostate cancer and bone metastases.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to depth of tumor penetration (T1 or T2 vs T3 vs T4), lymph node involvement (0 vs 1-3), and extent of lymphadenectomy (D1 or D2 vs D0 or unknown). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive leucovorin calcium IV and fluorouracil (5-FU) IV on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days between course 2 and 3. Arm II: Patients receive epirubicin IV over 3-15 minutes and cisplatin IV over 1 hour on day 1 and 5-FU IV continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses. Patients are followed every 3 months for 2 years, every 4 months for 2 years, and then annually for 3 years.

This randomized phase III trial is studying imatinib mesylate to see how well it works compared to placebo in treating patients with primary gastrointestinal stromal tumor that has been completely removed by surgery. Imatinib mesylate may interfere with the growth of tumor cells and may be an effective treatment for patients with primary gastrointestinal stromal tumor that has been completely removed by surgery. Study Design: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment Study arms: I. STI571 Arm: Adjuvant treatment with STI571 at 400mg/day for 1 year. II. Placebo Arm: Adjuvant treatment with a matching placebo for 1 year.

RATIONALE: Monoclonal antibodies, such as epratuzumab and rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibody therapy together with chemotherapy may kill more cancer cells.> PURPOSE: This phase II trial is studying how well giving monoclonal antibody therapy together with combination chemotherapy works in treating patients with stage II, stage III, or stage IV diffuse large B-cell lymphoma.

This randomized phase III trial was originally designed to compare three different combination chemotherapy regimens to see how well they work. As of September 1, 2004, the study was expanded to a total of 6 arms (the original 3 arms (A, B, C) and 3 additional arms which were the same as the first 3 but with cetuximab) in treating patients who have undergone surgery for stage III colon cancer. Drugs used in chemotherapy, such as irinotecan hydrochloride, fluorouracil, leucovorin calcium, and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining more than one chemotherapy drug with monoclonal antibody therapy and giving them after surgery may kill any remaining tumor cells. It was not known at the time this study was developed which combination chemotherapy regimen is more effective after surgery in treating colon cancer. This study had several key changes, based on the results of other phase III trials. As of 6/1/2005, patients no longer received irinotecan on this study and treatment arms B, C, E, and F were discontinued. Patients on arms B and C crossed to arm A. Patients on arms E and F crossed to arm D. Patients on arms C and F who had not gotten to irinotecan continued on arms A and D, respectively. As of 8/18/2008, pre-screening for Kirsten rat sarcoma (KRAS) status was added with mutant KRAS (or KRAS not evaluable) patients put on arm G and wild-type KRAS patients randomized between arm A and arm D. Patients on arm G were treated per physician discretion and followed for disease and survival status. KRAS was determined in a central laboratory and was process for all patients on this study. The primary endpoint of this study was modified on 8/18/2008 to focus on patients having wild-type KRAS tumors.

RATIONALE: Use of a nicotine inhaler and/or bupropion may be effective in helping people stop smoking and prevent them from starting smoking again. It is not yet known whether a nicotine inhaler or bupropion are more effective alone or combined for stopping smoking. PURPOSE: Randomized phase III trial to compare the effectiveness of the nicotine inhaler or bupropion alone to that of the nicotine inhaler combined with bupropion in helping people to stop smoking and prevent starting smoking again.

This is a randomized, multicenter study. Patients are stratified according to participating center, primary surgeon, site of primary tumor (right vs left vs sigmoid), and American Society of Anesthesiologists disease classification (I and II vs III). Patients are randomized to one of two treatment arms. The extent of colon resection is identical for both arms.

This randomized phase III trial studies cyclophosphamide and doxorubicin hydrochloride compared with paclitaxel as adjuvant therapy in treating breast cancer in women with 0-3 positive axillary lymph nodes. Giving additional cancer treatment after surgery may help to lower the risk that the cancer will come back (adjuvant therapy). Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether the standard adjuvant therapy of cyclophosphamide and doxorubicin hydrochloride is more effective than paclitaxel in treating women with breast cancer

This randomized phase III trial studies cyclophosphamide and doxorubicin hydrochloride compared with paclitaxel as adjuvant therapy in treating breast cancer in women with 0-3 positive axillary lymph nodes. Giving additional cancer treatment after surgery may help to lower the risk that the cancer will come back (adjuvant therapy). Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether the standard adjuvant therapy of cyclophosphamide and doxorubicin hydrochloride is more effective than paclitaxel in treating women with breast cancer

This open-label, randomized, controlled, multicenter Phase 2 study compared gemcitabine elaidate with gemcitabine as first-line therapy in patients with mPDAC. Eligible patients were randomized (1:1) to receive either gemcitabine elaidate or gemcitabine, which was infused intravenously over 30 ? 3 minutes, under medical supervision. Each cycle of gemcitabine elaidate was administered weekly for 3 of every 4 weeks (4th week rest) at a dose of 1250 mg/m2/day. The first cycle of gemcitabine comprised weekly administration of 1000 mg/m2/day for 7 weeks (8th week rest); subsequent cycles comprised weekly administration for 3 weeks every 4 weeks, in accordance with the manufacturer?s labeling. Dosing was to be delayed or decreased according to the protocol-specified toxicity criteria. Dose escalation beyond the starting dose was allowed if patients tolerated the first cycle (8 weeks) of gemcitabine or first 2 cycles (8 weeks) of gemcitabine elaidate, according to the criteria defined in the protocol. Protocol-specified treatment (PST) was continued until there was clinical tumor progression or unacceptable toxicity. The study was closed when the required number of events of death (80% events) had been observed in patients with low hENT1 tumor expression. Serial assessments for antitumor efficacy, adverse events, pain severity, and health status were performed in all patients. Tumor hENT1 status was determined after randomization but before the final efficacy analysis using predefined criteria to classify patients as hENT1 -high or -low so that the primary endpoint population (patients with low tumor hENT1 expression) could be identified prospectively.

RATIONALE: Combination chemotherapy before a stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the transplanted stem cells. When the healthy stem cells are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. If the patient's stem cells are to be transplanted, the patient can also be treated with a monoclonal antibody, such as gemtuzumab ozogamicin, to kill any remaining cancer cells or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without gemtuzumab ozogamicin followed by stem cell transplant in treating acute myeloid leukemia. PURPOSE: This randomized, multi-step phase III trial is studying combination chemotherapy, gemtuzumab ozogamicin, and stem cell transplant to see how well they work compared to combination chemotherapy and peripheral stem cell transplant alone in treating patients with acute myeloid leukemia.

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is most effective in treating advanced colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients who have advanced, recurrent, or metastatic colorectal cancer that cannot be treated with surgery or radiation therapy.

Randomized phase III trial to compare the effectiveness of surgery with or without monoclonal antibody therapy in treating patients who have stage II colon cancer. Monoclonal antibodies such as edrecolomab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether surgery to remove colon cancer is more effect with or without monoclonal antibody therapy.

This study is being done to compare two types of surgery currently used for rectal cancer. The two types of surgery are laparoscopic-assisted rectal resection and open laparotomy rectal resection. Although laparoscopic-assisted rectal resection is being used for rectal cancer in some medical centers, the effectiveness of this type of surgery compared to open surgery is unknown. The study will compare the safety and effectiveness of the surgeries, recovery from surgery in the hospital, overall recovery from surgery and cancer outcome. Study Type: Interventional Study Design: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment A randomized phase III trial evaluating the safety and efficacy of laparoscopic resection for rectal cancer. Using a 1:1 randomization, patients go on to Active Comparator: Arm 1: Open laparotomy and rectal resection Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum. Experimental: Arm 2: Laparoscopic-assisted rectal resection Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.

RATIONALE: Surgery to remove lymph nodes in the armpit may remove cancer cells that have spread from tumors in the breast. PURPOSE: Randomized phase III trial to determine the effectiveness of removing lymph nodes in the armpit in treating women who have stage I or stage IIA breast cancer.

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs at different times or combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy consisting of either doxorubicin, cyclophosphamide, or paclitaxel given at different times with that of combination chemotherapy consisting of doxorubicin plus cyclophosphamide followed by paclitaxel in treating women with stage II or stage IIIA breast cancer.

This randomized phase II trial studies how well paclitaxel with or without carboplatin and/or bevacizumab followed by doxorubicin and cyclophosphamide works in treating patients with breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as paclitaxel, carboplatin, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bevacizumab may stop the growth of tumor cells by blocking blood flow to the tumor. Giving chemotherapy together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment Active Comparator: Arm I (paclitaxel, doxorubicin, cyclophosphamide) Patients receive paclitaxel IV over 60 minutes once weekly in weeks 1-12. Patients then receive dose-dense doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 5-30 minutes (ddAC) once in weeks 13, 15, 17, and 19. Experimental: Arm II (paclitaxel, ddAC, bevacizumab) Patients receive paclitaxel and ddAC as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes in weeks 1, 3, 5, 7, 9, 11, 13, 15, and 17. Experimental: Arm III (paclitaxel, ddAC, carboplatin) Patients receive paclitaxel and ddAC as in Arm I. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10. Experimental: Arm IV (paclitaxel, ddAC, bevacizumab, carboplatin) Patients receive paclitaxel and ddAC as in Arm I, bevacizumab as in Arm II, and carboplatin as in Arm III.

This randomized phase III trial studies the side effects and how well different chemotherapy regimens with or without bevacizumab work in treating patients with stage IIIC or stage IV breast cancer. Drugs used in chemotherapy, such as paclitaxel, paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel), and ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab may block tumor growth by targeting certain cells and slowing the growth of blood vessels to the tumor. It is not yet known which treatment regimen is more effective in treating patients with breast cancer. Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment This is a randomized phase III trial, a 3-arm study with equally weighted randomization. Arm A = Control, Paclitaxel (Pac) Arm B = Experimental, Nab-paclitaxel (Nab) Arm C = Experimental, Ixabepilone (Ixa) Each arm +/- Bevacizumab (Bev)

Study LYM-3001 was a multi-center, international, randomized, open-label study designed to determine whether VELCADE with rituximab provided benefit to patients with relapsed or refractory, rituximab-naive or -sensitive follicular B-cell Non- Hodgkin's Lymphoma (B-NHL) relative to treatment with rituximab alone. The study was had an open-label treatment phase consisting of up to 5 cycles of treatment (5 weeks duration for each cycle, up to 25 weeks total treatment duration) and a posttreatment phase. Throughout the open-label treatment phase, the investigator assessed subject response to therapy using efficacy measurements and disease response criteria. Dose modifications were made as required according to dose-modification rules. During the posttreatment phase, subjects were followed for disease progression, initiation of subsequent therapy for NHL, and survival until the end of the study, which was expected to be 20 months after the last subject was randomized on study. Subjects were stratified based on: Follicular Lymphoma International Prognostic Index (FLIPI) score (low [0-1 factor] vs intermediate [2 factors] vs high [>=3 factors]), prior rituximab therapy (yes vs no), time since last dose of anti-lymphoma therapy (<=1 vs >1 year), and region (US vs EU vs Rest of World). Subjects were randomized to Treatment Arms A or B in a 1:1 ratio as follows: - Treatment Arm A (test arm): 1.6 mg/m2 VELCADE for Injection was administered by IV bolus weekly on Days 1, 8, 15, and 22 of a 35-day cycle, followed by single bolus of 375 mg/m2 rituximab on Day 1 of Cycles 2 to 5. Subjects also received rituximab as per Treatment Arm B. - Treatment Arm B (control arm): 375 mg/m2 rituximab once a week on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m2 on Day 1 of Cycles 2 to 5 (for a total of 8 doses).

This is a multinational, randomized, double-blind, placebo-controlled, Phase 3 study conducted at 151 study sites. The study was designed to compare the efficacy and safety of abiraterone acetate plus prednisone with that of placebo plus prednisone in medically or surgically castrated asymptomatic or mildly symptomatic men with mCRPC who have not received cytotoxic chemotherapy. Subjects were stratified according to ECOG performance status Grade (0 versus 1) and were randomly assigned (1:1) to receive abiraterone acetate plus prednisone or placebo plus prednisone. Prednisolone was used in Europe; it was used in Australia when prednisone was not available. Eligible subjects received 1,000 mg of abiraterone acetate (administered as 4 x 250 mg tablets) or 4 placebo tablets once daily plus prednisone 5 mg twice daily. Food was not to be consumed for at least 2 hours before and for at least 1 hour after the dose of study drug. The study consisted of a Screening Period (within 14 days before Cycle 1 Day 1), a Treatment Period (starting at the first dose on Cycle 1 Day 1 and ending with the End-of-Study Treatment Visit), and a Follow-up Period (follow-up for survival every 3 months up to 5 years). Each treatment cycle was 28 calendar days. While treatment was administered on a continuous schedule, each cycle of treatment was defined as 28 calendar days. Dosing compliance was evaluated during the Cycle 1 Day 15 visit, on Day 1 of each subsequent cycle, at treatment discontinuation, if applicable, and at the End-of-Study Treatment Visit. Safety assessments were based on medical history, measurements of vital signs, and physical examinations.

Study Design: ROSE was a global, Phase 3, multicenter, randomized, double-blind, placebo-controlled study that compared ramucirumab in combination with docetaxel to placebo in combination with docetaxel in previously untreated patients with HER2-negative, unresectable, locally-recurrent or mBC. Randomization was stratified by prior taxane therapy (yes/no), visceral metastasis (yes/no), hormone receptor status (positive vs. negative/unknown), and geographical region (the Americas vs. Europe/Australia/New Zealand vs. Asia/Middle East/Africa). Patients were randomized on a 2:1 basis to receive on Day 1 (? 3 days) of each 21-day cycle, either: ? Docetaxel (75 mg/m2) as an approximately 1-hour intravenous (IV) infusion followed by ramucirumab (10 mg/kg) as an approximately 1-hour IV infusion; or ? Docetaxel (75 mg/m2) as an approximately 1-hour IV infusion followed by placebo (10 mg/kg) as an approximately 1-hour IV infusion.

These datasets are cited in The Lancet Oncology manuscript: Estimation of tumour regression and growth rates during treatment in patients with advanced prostate cancer and is provided as a reference to The Lancet Oncology readers and other researchers. All data in these files are originally from individual datasets hosted on the Project Data Sphere online service; the specific files are noted in the manuscript.

Study 21005 was a randomized, double-blind, multicenter, phase 3 study evaluating orteronel plus prednisone, compared with placebo plus prednisone, in men with metastatic, castration-resistant prostate cancer (mCRPC). Patients were randomized to receive orteronel 200 mg tablets BID plus prednisone 5 mg BID or placebo tablets plus prednisone 5 mg BID in a 2:1 ratio, stratified by region (North America [US and Canada], Europe, rest of world) and Brief Pain Inventory-Short Form (BPI-SF) worst pain score at screening (4 vs >4). Each 28-day treatment cycle was composed of continuous twice-daily study drug plus prednisone, and continued until radiographic disease progression was documented. Gonadotropin-releasing hormone (GnRH) analogue therapy was continued unless the patient was surgically castrated. Patients were to have evidence of disease progression during or after receiving a total of 360 mg/m2 docetaxel within a 6-month period. Patients who were clearly intolerant to docetaxel or had progressive disease before receiving 360 mg/m2 were also eligible if they had received 225 mg/m2 of docetaxel within a 6-month period and met the other study entry criteria. Two formal interim analyses were planned for this study. Upon the recommendation of the independent data monitoring committee to unblind the study, patients who received placebo were allowed to crossover to orteronel treatment.

This large phase III clinical study is studying the effect of vandetanib (ZACTIMA) in treating non-small cell lung cancer (NSCLC). Vandetanib is a new type of agent that targets the blood supply to a cancer tumour (through it's anti-vascular endothelial growth factor receptor (VEGFR) properties) and the tumour cells themselves (through it's anti-endothelial growth factor receptor (EGFR) actions). This study will look at the effects of vandetanib in lung cancer patients who have had their cancer re-appear after treatment with standard chemotherapy. This clinical study will test if the vandetanib anti-VEGF and anti-EGFR characteristics can deliver longer improved progression free survival and improved overall survival than docetaxel (Taxotere) alone. All patients participating this clinical study will receive treatment with docetaxel, a commonly used treatment for recurrent non-small cell lung cancer. In addition, some patients will also receive vandetanib (ZACTIMA), an anti-EGFR / anti-VEGF agent. Recent clinical research shows that vascular endothelial growth factor receptor (VEGFR) inhibition, when used with standard chemotherapy, can lead to increased survival in advanced non-small cell lung cancer (NSCLC) patients. Other research shows that epidermal growth factor receptor (EGFR) inhibitors, like erlotinib (Tarceva) can also increase overall non-small cell lung cancer survival by killing tumour cells and stopping them from dividing.

This is an international phase 3, randomized, double-blind,active controlled study comparing denosumab with zoledronic acid in the treatment of bone metastases in subjects with advanced cancer or multiple myeloma. Approximately 1690 subjects will be randomized in a 1:1 ratio to receive either denosumab, administered at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W), or zoledronic acid, administered IV at a dose of 4 mg (equivalent creatinine clearance-adjusted dose in subjects with baseline creatinine clearance . 60 mL/min) as a single, minimum 15-minute infusion Q4W in a blinded manner. Randomization will be stratified by tumor type (non-small cell lung cancer or multiple myeloma or other), previous SRE (Yes or No), systemic anti-cancer therapy (eg, chemotherapy, biologic therapy or hormonal therapy; Yes or No) and region (Japan or other countries). Within each stratum subjects will be randomized using an equal allocation ratio of 1:1. Stratification for tumor type will be bounded for this study limiting the enrollment to the non-small cell lung cancer stratum to 60% of the total study population and the multiple myeloma stratum to 10%. Each subject will receive either an SC injection of denosumab and an IV infusion of zoledronic acid placebo Q4W, or an SC injection of denosumab placebo and an IV infusion of zoledronic acid Q4W until approximately 745 subjects have experienced an on-study SRE and the primary efficacy and safety analysis is completed.

This is an international, phase 3, randomized, double-blind, placebo-controlled study in subjects with castrate-resistant prostate cancer. Subjects were randomized in a 1:1 ratio to receive 120 mg denosumab or placebo SC Q4W. The randomization schedule was stratified based on PSA criteria (PSA level "d 8.0 ng/mL AND PSA doubling time "T 10.0 months [yes/no]) and previous or current chemotherapy for prostate cancer (yes/no). Subjects enrolled in the study received investigational product Q4W in a blinded manner until the results of the efficacy and safety analyses were completed (ie, until the end of the extended blinded treatment phase).

This was an international, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of denosumab in men undergoing ADT for nonmetastatic prostate cancer. Subjects were randomized in a 1:1 allocation to receive either 60 mg denosumab or placebo subcutaneously once every 6 months for 30 months (ie, the 36-month treatment period). Randomization was stratified by age group (< 70 years vs ? 70 years) and duration of ADT with GnRH agonist or orchiectomy at study entry (? 6 months vs > 6 months). Eligible subjects were men with histologically-confirmed prostate cancer and were ? 70 years of age, or were < 70 years of age with either low baseline BMD (T-score at the lumbar spine, total hip, or femoral neck < -1.0) or history of an osteoporotic fracture.

This was a multicenter, randomized, double-blind, placebo-controlled study in subjects receiving adjuvant aromatase inhibitor therapy for nonmetastatic breast cancer. Subjects were randomized in a 1:1 allocation to receive either 60 mg denosumab or placebo subcutaneously once every 6 months for 24 months (a total of 4 injections) (ie, the 24-month treatment period). Randomization was stratified by duration of aromatase inhibitor therapy (. 6 months vs > 6 months). Subjects were followed for 24 months after the last dose of investigational product (ie, the 24-month safety follow-up period).

The purpose of this study is to compare gefitinib with carboplatin / paclitaxel doublet chemotherapy given as first line treatment in terms of progression free survival in selected NSCLC patients with the objective of demonstrating non-inferiority.

The purpose of this study is to compare the effects of ZD1839 or docetaxel in patients with advanced non-small cell lung cancer (NSCLC) that has recurred or progressed after receiving prior treatment with platinum-based chemotherapy.

Study H3E-MC-JMHR (JMHR) is a double-blind, randomized, Phase 3 study in patients with HNC that is recurrent and not amenable to local therapy (surgery or radiation) or newly diagnosed distant metastatic disease. Approximately 790 patients are enrolled in this study. Eligible patients are randomized to one of the following treatment arms: Arm A (experimental arm): pemetrexed 500 mg/m2 plus cisplatin 75 mg/m2 on Day 1 every 21 days, Arm B (control arm): placebo plus cisplatin 75 mg/m2 on Day 1 every 21 days. Patients are evenly assigned (1:1 randomization) to the treatment arms based on the following randomization factors: Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1 versus 2), previously treated for HNC (no versus yes), distant metastasis (no versus yes), prior platinum-based therapy (no versus yes), and country. The primary efficacy measure is OS. Secondary endpoints include PFS, ORR, and DoR; time to worsening (TTW) in dimensions of health-related quality of life (HRQoL) using FACT-H&N, change from baseline in dimensions of HRQoL using FACT-H&N, and safety.

This Prostate Cancer DREAM Challenge data includes the curated training dataset as well as two validation datasets. All source data is hosted on ProjectDataSphere.org and available study documentation (e.g. case report form, protocol, etc.) may be viewed by visiting the links below.

The training dataset was curated from three different data sets:
(1) VENICE: https://projectdatasphere.org/projectdatasphere/html/content/83
(2) ASCENT2: https://projectdatasphere.org/projectdatasphere/html/content/89
(3) MAINSAIL/CELGENE: https://projectdatasphere.org/projectdatasphere/html/content/90

The validation datasets - named leaderboard and validation - were used for interim and final scoring, respectively. These datasets are subsets of the ENTHUSEM1C study located here: https://projectdatasphere.org/projectdatasphere/html/content/104

To learn more about the Prostate Cancer DREAM Challenge, please visit: http://dreamchallenges.org/project/project-dataspheres-prostate-cancer-challenge/

Study H3E-MC-JMIG (JMIG) is a multicenter, randomized, open-label, Phase 3 trial of patients with locally advanced, unresectable/inoperable, Stage III NSCLC other than predominantly squamous cell histology (nonsquamous) without malignant pleural/pericardial effusion. Approximately 600 patients will be randomized. Randomization will be at a 1:1 ratio between the experimental arm (Arm A; pemetrexed, cisplatin, and concurrent TRT for 3 cycles, followed by consolidation pemetrexed for 4 cycles), and the control arm (Arm B; etoposide, cisplatin, and concurrent TRT for 2 cycles, followed by consolidation with cytotoxic platinum-based doublet regimen of choice [excluding pemetrexed] for a maximum of 2 cycles). Concurrent chemoradiotherapy cycles are 21 days for Arm A, and 28 days for Arm B. Patients will be evenly randomized to treatment arms using an Interactive Voice Response System (IVRS) at a central location. The IVRS will assign patients to treatment arms according to a stratified method of randomization. In other words, there will be a separate and independent randomization within each of 16 strata or subgroups, defined by all 16 combinations of values of the following prognostic factors: ? Baseline ECOG performance status (0 versus 1) ? Gender (female versus male) ? Stage of disease (IIIA versus IIIB) ? PET scan (yes versus no).

This dataset was used as validation data for the Prostate Cancer DREAM Challenge. To view the curated training dataset, which includes 3 mCRPC datasets from ProjectDataSphere.org, visit: <a href='https://www.projectdatasphere.org/projectdatasphere/html/content/149'>https://www.projectdatasphere.org/projectdatasphere/html/content/149</a><br><br> Enthuse M1 is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in patients with hormone resistant prostate cancer and bone metastases. -This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve survival compared with placebo. -ZD4054(Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin A receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer patients with bone metastases. - All patients participating in this clinical trial will receive existing standard prostate cancer treatments in addition to trial therapy. - Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to standard prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may slow the progression of the tumour. - No patients will be deprived of standard prostate cancer therapy. Study Design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

This is a prospective, multicentre, multinational, non blinded, randomized phase 2/3 study. The Phase Ill part of the study (for which this data is for) will compare the survival between the selected investigational arm and the control arm. A closed testing procedure will be used to combine a test of superiority of the investigational arm relative to the control and a test of equivalence between the investigational arm and the control with respect to survival. The study population is patients with metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease. After having properly checked all eligibility criteria, obtained patient informed consent and baseline quality of life questionnaire filled in, patients will be randomized in the study. A patient who has been treated prior to registration will not be accepted for the study.

This was a multicenter, non-blinded, randomized, stratified phase II-III study. The phase II part of the study was planned to estimate overall response rate and to evaluate toxicity in 3 treatment groups-Taxotere plus cisplatin (TP), Taxotere plus 5-FU (TF), and cisplatin plus 5-FU (PF)-administered as first-line treatment for patients with recurrent and/or metastatic SCCHN. Additionally, the phase II part of the study was to determine which regimen(s) to continue in the phase III part of the study. The phase III part of the study compared 2 chemotherapy regimens as first-line treatment for patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). Patients were randomized (1:1) to receive either TP or PF. Patients were stratified at inclusion according to country and extent of disease. Patients were to receive 6 cycles of chemotherapy at 3-week intervals unless progression of disease (PD) or unacceptable toxicity occurred, or the patient refused treatment. Further treatment was indicated for patients with objective response or stable disease. All patients were to be followed until death.

Study JMHD is a multicenter, randomized, open-label, Phase 3 trial. Eligible patients will be randomized in a 1:1 ratio to 1 of the following treatment arms: Arm A - Pemetrexed, carboplatin, and bevacizumab followed by pemetrexed and bevacizumab (450 patients), Arm B- Paclitaxel, carboplatin, and bevacizumab followed by bevacizumab (450 patients). Patientsrandomized to Arm A will receive folic acid, vitamin B12, and dexamethasone as stated in the pemetrexed label. Before administration of paclitaxel, patients randomized to Arm B will receive premedication (dexamethasone, diphenhydramine, and cimetidine or ranitidine) as recommendedin the paclitaxel label. Randomization will be stratified by the following factors: disease stage (IIIB with pleural effusions versus IV), measurable versus nonmeasurable disease, ECOG performance status (0 versus 1), and sex (male versus female).

This was a randomized, open-label, comparative study of DOXIL and Paclitaxel in the treatment of subjects with epithelial ovarian carcinoma following failure of first-line chemotherapy with a platinum-based regimen. Subjects entering the trial were stratified by platinum-sensitivity and bulky disease. Protocol-eligible subjects with measurable disease, who had received no more than 1 prior platinum-based regimen, were randomized in a 1:1 ratio within each stratum to receive either a 1-hour intravenous infusion of DOXIL 50 mg/m2 every 28 days or paclitaxel 175 mg/m2 as a 3-hour infusion every 21 days. Subjects were to have been treated for up to 1 year. Subjects underwent appropriate radiologic imaging (x-ray, CT scan, MRI) to document baseline disease, as well as a chest x-ray and an assessment of left ventricular ejection fraction (LVEF) by multiple-gated acquisition scan within 30 days prior to the first dose of study drug. Subjects were followed weekly for hematologic toxicities. Radiologic imaging was repeated every 7 to 8 weeks to assess disease status. Subjects who achieved complete or partial response were reevaluated 4 weeks later to confirm the initial observation of response. All subjects were to have been followed for a minimum of 1 year for survival and disease progression. The study was closed to new subjects on 31 August 1999, because of poor accrual after Taxol (paclitaxel HCl) was approved for use in combination with platinum-based therapy for the first-line treatment of ovarian cancer by the European Agency for the Evaluation of Medicinal Products.

This was a Phase 3, parallel-group, randomized, multicenter, open-label, active-controlled study of women with epithelial ovarian carcinoma whose disease did not respond to or recurred after treatment with first-line chemotherapy with a platinum-based regimen. They had measurable disease and a Karnofsky performance status (KPS) of 60% or higher. Subjects received either a 1-hour i.v. infusion of DOXIL, 50 mg/m2 every 4 weeks, or topotecan, 1.5 mg/m2 per day as a 30-minute i.v. infusion for 5 consecutive days, repeated every 3 weeks. The dose of DOXIL used (50 mg/m2 via 1-hour i.v. infusion every 4 weeks) was selected on the basis of the results of Phase 1 and Phase 2 studies, which indicated that this dose had meaningful clinical activity and was well tolerated. Topotecan was administered at the FDA-approved dose and frequency for treatment of ovarian cancer. To obtain 370 evaluable subjects, up to 460 subjects were to have been enrolled in the study. Subjects were randomized to treatment in a 1:1 ratio stratified by platinum sensitivity and the presence or absence of bulky disease. According to the standards of care for this patient population at many participating sites, subjects could discontinue study treatment and be considered to have completed the protocol at the discretion of the investigator or subject after 6 months (6 cycles of DOXIL, 8 cycles of topotecan). Subjects with ongoing clinical benefit were able to continue study drug until disease progression upon approval of the sponsor. All randomized subjects who met enrollment criteria and received at least 2 cycles of study drug were considered evaluable for efficacy. Subjects who withdrew from the study were not replaced.

Randomized phase III trial to compare the effectiveness of surgery with or without monoclonal antibody therapy in treating patients who have stage II colon cancer. Monoclonal antibodies such as edrecolomab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether surgery to remove colon cancer is more effect with or without monoclonal antibody therapy.

This is an open-label, randomized, multi-center, Phase III trial to compare ABI-007 in combination with gemcitabine administered weekly to standard treatment (gemcitabine monotherapy) with respect to overall survival, objective tumor response rate and PFS in patients diagnosed with metastatic adenocarcinoma of the pancreas. Patients will be randomized to one of the following treatment regimens: - ABI-007 125 mg/m2 administered in combination with gemcitabine 1000 mg/m2 weekly for 3 weeks followed by one week of rest or - Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks followed by a week of rest (Cycle 2 onward). Test Product, Dose, and Mode of Administration: ABI-007 plus gemcitabine: ABI-007 125 mg/m2, IV infusion over 30-minute, followed by gemcitabine 1000 mg/m2 as a 30-minute IV infusion; weekly for 3 weeks (on Days 1, 8, and 15) followed by a week of rest. Gemcitabine alone: gemcitabine 1000 mg/m2 as a 30-minute IV infusion: Cycle 1 - administered weekly for 7 weeks followed by a week of rest. Cycle 2 onwards - weekly administration for 3 weeks (on Days 1, 8, and 15) followed by a week of rest. Duration of Treatment: Patients may continue on treatment until they experience progressive disease or unacceptable toxicity, require palliative radiotherapy, withdraw consent, or their physician feels it is no longer in their best interest to continue on treatment. Efficacy Assessments: Patients will have CT scans performed every 8 weeks and evaluated by a blinded, centralized reading center using the RECIST guidelines for complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD). Functional tumor response will be evaluated by PET scans performed every 8 weeks. CA19-9 response will be assessed by radioimmunoassay.

This will be a global multi-center, open-label, two-arm randomized, phase III clinical trial. Patients will be randomized to treatment with RPR109881 (test arm) or capecitabine (comparator arm). Patients will be stratified based on the treatment setting of prior taxane administration, prior taxane responsiveness, and region. Patients will continue to receive treatment until disease progression, patient intolerance, or withdrawal of consent. Patients who discontinue study treatment prior to disease progression will continue to have tumor assessments every 6 weeks until disease progression. Following disease progression, patients will be treated by their physicians as determined by usual medical practice and followed for survival. Patients treated on the capecitabine arm will not be eligible to receive RPR109881 in this or other clinical trials for breast cancer.

A Phase 3, multicenter, international, randomized open-label, 2-arm trial comparing 2 chemotherapy regimens: cisplatin (control arm) versus cisplatin and tirapazamine (experimental arm), each regimen used with concomitant radiation in the treatment of advanced head and neck cancer. Subjects with previously untreated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx, Stage III or Stage IV (excluding T1N1, T2N1, and metastatic disease). Subjects must have ambulatory Eastern Cooperative Oncology Group (ECOG) performance status =< 2 and adequate renal, hepatic, and hematologic function.

Main diagnosis and criteria for inclusion: 1) Histologically or cytologically-proven adenocarcinoma of the colon or rectum. 2) metastatic disease not amenable to potentially curative treatment. 3) no prior chemotherapeutic regimen for metastatic disease. 4) disease free interval from end of adjuvant chemotherapy >6 months 5) no prior adjuvant chemotherapy with oxaliplatin. 6) at least 1 unidimensionally measurable lesion (RECIST) 7) no peripheral neuropathy 8) detectable sensory action potential (SAP) 9) age >=18 years, WHO Performance Status (PS): 0, 1, or 2; and adequate organnfunction. 10) signed written informed consent.

Control arm A: oxaliplatin + 5-FU/LV + placebo. Experimental arm B: oxaliplatin + 5-FU/LV + xaliproden. Diagnosis and main criteria for inclusion: 1) Age >= 18 years. 2) WHO performance status : 0 or 1. 3) Histologically or cytologically-proven metastatic cancer of the colon or rectum; metastatic disease not curable by surgery or amenable to radiation therapy with curative intent. 4) Measurable disease: at least one unidimensionally measurable lesion with a diameter >= 20 mm using conventional computerized tomography (CT) or magnetic resonance imaging (MRI) scans or >= 10 mm using spiral CT scans. 5) Prior adjuvant chemotherapy with 5-FU/LV, with 5-FU/levamizole, with irinotecan/5-FU/LV, with capecitabine allowed provided disease-free interval from end of the adjuvant therapy > 6 months, with oxaliplatin/5-FU/LV provided the progression free interval from end of adjuvant therapy > 12 months. 6) No PSN > grade 1.

This is a prospective, multicenter, multinational, randomized (1:1), double-blind, placebo-controlled, parallel-group study comparing the efficacy of aflibercept in term of overall survival versus placebo administered on top of gemcitabine in patients with metastatic pancreatic cancer (MPC). Each patient will be treated until disease progression, unacceptable toxicity, or patient's refusal. Following documentation of progressive disease patients will be followed-up for survival status.

This is a prospective, multicenter, multinational, randomized (1:1), double-blind, parallel-group study comparing the efficacy in term of overall survival (OS) of aflibercept (Arm A) versus placebo (Arm B) administered on top of the standard docetaxel regimen as secondline treatment for patients with NSCLC. Each patient will be treated until disease progression, unacceptable toxicity, or patient's refusal.

Multicenter, international, open-label, randomized study comparing 2 treatment regimens (FOLFOX4 versus LV5FU2) as adjuvant treatment of Dukes stage B2-C colon cancer. The minimization method was used in order to balance treatment allocation according to the following stratification factors: center, extent of invasion of the primary tumor through the wall of the colon and tumor adherence (T1, T2, T3, T4), number of involved lymph nodes (N0, N1, N2), bowel obstruction (present, absent) and tumor perforation (present, absent).

This is a prospective, multicenter, multinational, randomized (1:1), double-blind, parallel-arm study of aflibercept versus placebo in patients with MCRC being treated with FOLFIRI after failure of an oxaliplatin based regimen. Each patient will be treated until disease progression, unacceptable toxicity, or patient's refusal. Following documentation of progressive disease patients will be followed-up for survival status. Note that 614 subjects were randomized to a planned treatment arm of Placebo, however 4 of these subjects were given Aflibercept. These 4 patients were therefore excluded from all the de-identified datasets, bringing the total patient count to 610.

The primary objective of the study was to determine overall survival (OS) of patients with advanced hepatocellular carcinoma (HCC) treated with sunitinib vs. sorafenib. The study was designed to A total enrolled 1200 patients , 600 per arm, and treatment was to continue until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria were met.

The primary objective of this study is to demonstrate that addition of cetuximab to 1st-line treatment with capecitabine (Xeloda, X) and cisplatin (P) [XP] chemotherapy regimen has a clinically relevant benefit for subjects with advanced gastric adenocarcinoma including gastroesophageal junction (GEJ) adenocarcinoma, in terms of progression free survival (PFS). Secondary objectives are to assess cetuximab plus XP versus XP alone with respect to overall survival, overall tumor response, quality of life (QoL) and safety.

Prospective, non-blinded randomized phase Ill trial. Patients will be post-surgically stratified at inclusion first according to the participating institution then according to number of axillary lymph nodes involved (1 to 3; 4 and more) and will be randomly assigned to receive either: TAC: Docetaxel 75 mg/m2 as 1 hour i.v. infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500 mg/m2 as i.v. bolus on day 1 every 3 weeks. OR FAC: 5-fluorouracil 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks in combination with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks. Dose reduction and/or treatment delay and treatment discontinuation are planned for the 2 arms in case of severe hematological and/or non-hematological toxicities. For Both Arms: Tamoxifen 20 mg p.o. daily for 5 years, starting 3 to 4 weeks after the last course of chemotherapy for patients with positive estrogen and/or progesterone receptors unless there is a contraindication for the use of tamoxifen therapy. Patients treated with lumpectomy will undergo postoperative radiation therapy after completion of chemotherapy and resolution of any side effect. Postmastectomy radiation therapy, and ipsilateral nodal radiation therapy, may be used at the discretion of the treating radiation oncologist. This will be done according to the guidelines at each institution. All included patients in both arms will receive a fixed number of 6 cycles of treatment.

Patients will be post-surgically stratified at inclusion according to: participating center, number of axillary lymph nodes involved (1 to 3; 4 and more), age (< 50; >=50), and will be randomly assigned to receive either: Arm A1 4ADM->3CMF; Arm A2 4AC->3CMF;Arm B 3ADM-> 3TXT-> 3CMF; Arm C 4AT ->3CMF Where: ADM = doxorubicin (75), AC = doxorubicin + cyclophosphamide(60/600), TXT = docetaxel (100), AT = doxorubicin + docetaxel(50/75).The first cycle should be administered within 8 days following the randomization date. Dose-reduction and/or treatment delay and treatment discontinuation are planned for the 4 arms in case of severe hematological and/or non hematological toxicity. Hormonotherapy: (for Arms A1, A2, B and C) Tamoxifen 20 mg p.o. daily for 5 years, starting 4 to 5 weeks after day 1 of the last course of chemotherapy, in patients with ER and/or PgR positive tumors (i.e. >=1 per cent cells staining positively for ER and /or PgR with the immunohistochemistry technique, regardless of intensity. Radiotherapy: (for Arms A1, A2, B and C) Radiotherapy will be mandatory in case of breast-conservative surgery; allowed in case of mastectomy , according to the policy in use at each participating center. Each center will specify its own policy before study activation. Radiotherapy will begin 4 to 6 weeks after day 1 of the last course of CMF. Concomitant CMF and radiotherapy will be allowed although not recommended. Prophylactic regimens: Steroids:(only for Arms B and C during treatment with docetaxel). Antibiotics: (only for Arm C during treatment with AT).

This was a randomized, active control, parallel-group, open-label, multicenter study designed to determine if women with locally advanced or metastatic breast cancer, who were previously treated with anthracyclines in the neoadjuvant or adjuvant setting, and who also had a disease-free interval of at least 12 months since the end of their last cytotoxic therapy, would benefit from the addition of DOXIL/CAELYX to docetaxel therapy. Prior to random assignment to treatment, subjects were assigned to strata according to whether they received prior cytotoxic chemotherapy for advanced disease (yes, no) and their Eastern Cooperative Oncology Group (ECOG) Performance Status scores (0, 1, 2) at baseline. Subjects were then randomly assigned in a 1:1 allocation within each stratum to receive either docetaxel, 75 mg/m2 on Day 1 of every 21-day cycle or DOXIL/CAELYX 30 mg/m2 followed by docetaxel 60 mg/m2 on Day 1 of every 21-day cycle. Treatment was to continue until disease progression or the occurrence of unacceptable treatment-related toxicity. In the absence of progression and unacceptable treatment-related toxicity, treatment was to continue for at least 2 cycles after a complete response was confirmed. For subjects with a partial response or stable disease, treatment could continue after a maximum objective response was obtained unless the subject experienced unacceptable treatment-related toxicity. Disease assessments were to occur at the end of Cycles 2, 4, 6, and 8, and then every 3 cycles until 52 weeks after the start of the study medication, and then every 4 cycles until disease progression. For subjects who discontinued study medication prior to disease progression, disease assessments were to occur every 6 weeks for the first 24 weeks after the start of study medication, and then every 9 weeks from 25 weeks to 52 weeks after the start of study medication, and then every 12 weeks until disease progression.

This was a Phase 3, double-blind, randomized, placebo-controlled, multicenter trial to evaluate the impact of maintaining Hb in the range of 12 to 14 g/dL using epoetin alfa in subjects with metastatic breast cancer who were receiving chemotherapy. A total of 939 subjects were enrolled in the study from 139 sites in 20 countries in Europe, Canada, South Africa, and Australia. Subjects were randomly assigned to receive either 40,000 IU epoetin alfa or placebo in a 1:1 ratio. Randomization was stratified by metastatic category (bone metastasis only versus other measurable metastatic lesions versus other non-measurable metastatic lesions) to ensure balance in the epoetin alfa and placebo arms. . Study drug was administered once a week by subcutaneous. injection to maintain Hb in the range of 12 to 14 g/dL for 12 months. Subjects could undergo a red blood cell (RBC) transfusion if clinically necessary during the study. Subjects who met the entry criteria were randomized, and study drug was administered when Hb was 13 g/dL or lower. Hemoglobin concentrations and reticulocyte counts were monitored weekly for the first 4 weeks of the study to determine either when study drug administration was to begin or whether a dose adjustment was necessary. After the first 4 weeks of study drug administration, Hb concentrations and reticulocyte counts were monitored every 3 to 4 weeks for the remainder of the double-blind treatment phase. The maximum dose of epoetin alfa was not to exceed 60,000 IU once a week. After subjects had been on the study for 12 months, they completed the double-blind phase of the study and had the option of receiving 40,000 IU epoetin alfa once a week to maintain Hb in the range of 12 to 14 g/dL in an open-label extension. During the open-label extension, Hb concentrations and reticulocyte counts were monitored frequently and survival reports were submitted every 6 months until death.

Design Subjects will participate in up to 2 weeks of screening during which time they will complete all screening procedures. Eligible subjects who have not received any prior cytotoxic chemotherapeutic agent for melanoma will be randomized in a 1:1 ratio to receive either STA-4783 213 mg/m2 in combination with paclitaxel 80 mg/m2 or paclitaxel 80 mg/m2 alone. Approximately 630 subjects will be enrolled. Subjects will be prospectively stratified using screening evaluations by: - M1-class (M1a or M1b vs. M1c with elevated LDH vs. M1c with normal LDH) - Prior permitted systemic treatment for melanoma as defined in inclusion number 9 (No prior treatment vs. Prior treatment resulting in discontinuation due to disease progressiprogression vs. Prior treatment resulting in discontinuation for a reason other than disease progression [eg, intolerance]) One treatment cycle will consist of weekly treatments for 3 weeks, followed by a 1-week rest period. Cycles will be repeated every 4 weeks until disease progression. Tumor assessments will be performed every 8 weeks from the date of randomization or sooner if the Investigator suspects progression has occurred based on clinical signs and symptoms. Crossover to the STA-4783/paclitaxel arm is not allowed on this study. Rationale for use of Paclitaxel Given the comparable efficacy data, paclitaxel is preferred as the active comparator in this study for a number of reasons. First, given that STA-4783 is only administered in combination with paclitaxel, the paclitaxel control allows the study to be blinded, thus increasing the rigor of the design. Second, this control will allow the best categorization of the safety profile of STA-4783 in combination with paclitaxel as compared to paclitaxel alone.

Bone complications associated with cancer arise from increased bone resorption and include bone pain, pathologic bone fractures, nerve compression, and hypercalcemia. Accumulating evidence suggests that most pathologic bone resorption relies on the RANK/RANKL pathway, which regulates the differentiation, survival, and activation of osteoclasts. Another key component of RANK/RANKL pathway is OPG, an endogenous decoy receptor that binds and neutralizes RANKL. The antiresorptive property of OPG has been demonstrated in murine models of hypercalcemia of malignancy and metastatic bone destruction. According to recent findings, it appears that maximum anti-resorptive effects due to RANKL-RANK pathway inhibition are more pronounced than those due to bisphosphonates.

Bone complications associated with cancer arise from increased bone resorption and include bone pain, pathologic bone fractures, nerve compression, and hypercalcemia. Accumulating evidence suggests that most pathologic bone resorption relies on the RANK/RANKL pathway, which regulates the differentiation, survival, and activation of osteoclasts. Another key component of RANK/RANKL pathway is OPG, an endogenous decoy receptor that binds and neutralizes RANKL. The antiresorptive property of OPG has been demonstrated in murine models of hypercalcemia of malignancy and metastatic bone destruction. According to recent findings, it appears that maximum anti-resorptive effects due to RANKL-RANK pathway inhibition are more pronounced than those due to bisphosphonates.

Study treatment will be administered q.d. s.c. (pre-filled syringes) at approximately 24 hours apart. Study treatment will be administered for the duration of the initial chemotherapy and until decision to change at least one antineoplastic drug (ie, addition or removal; however, in case of antineoplastic dose adjustment only, study medication will continue as planned) due to disease progression or toxicity unless this decision is made within the first 3 months. In case another chemotherapy regimen is started within the first 3 months, the study medication should be continued at least for 3 months (until the end of the regimen ongoing at the Month 3 visit). If the chemotherapy is stopped definitely within the first 3 months, the study medication will be discontinued. At any time during the course of the study, if a patient experiences signs or symptoms evocative of VTE, unscheduled diagnostic test(s) will be performed to confirm or rule out the presence of VTE. For all these events occurring up to 3 calendar days after the last IP injection, a package will be sent to the Central Independent Blinded Adjudication Committee (CIAC) for adjudication. If a PE is discovered incidentally on a lung imaging test for tumor evaluation, a package will be sent to the CIAC for adjudication. All bleeding events and deaths reported up to the follow-up visit will also be adjudicated. Duration of study period per patient is variable depending on study treatment duration. A followup visit is planned one month +/- 1 week after the end of treatment visit. In any case, the study will end at the latest 7 months (6-month treatment period + 1-month follow-up period) following randomization of the last patient (study end date). In addition, survival status (alive, dead, or lost to follow up) will be collected for all patients either one year after randomization or at the end of the study, (ie, 7 months following randomization of the last patient at the latest), whichever comes first.

Methodology: Prospective, non-blinded randomized phase III trial. Three thousand one hundred and thirty patients (3,130) were to be post-surgically stratified at inclusion according to center, number of axillary lymph nodes involved (1 to 3; 4 and more) and hormonal receptor status (estrogen and/or progesterone receptor status positive versus negative). They were randomly assigned to receive either: TAC x 6: Docetaxel 75 mg/m2 as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m2 as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. (Sequence of administration: doxorubicin followed by cyclophosphamide followed by docetaxel.) OR as treatment AC x 4 to T x 4: Doxorubicin 60 mg/m2 as an IV bolus in combination with cyclophosphamide 600 mg/m2 as IV followed by docetaxel 100 mg/m2 as 1 hour IV infusion on day 1 every 3 weeks. Efficacy endpoints: Primary, Disease-Free Survival (time from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix) or death from any cause whichever occurs first. Secondary: Overall Survival (time from the date of randomization to the date of death of any cause). Safety: Adverse events reported by the patient or noted by the investigator; standard hematology and blood chemistry. Quality of life: Patient self-completion of 3 types of questionnaires (EORTC QLQ-C30 (version 3.0), EORTC QLQ-BR23 (version 1.0), EUROQOL EQ-5D. Pathologic and molecular marker: Investigation of the following markers: ER, PR, p53, MIB-1 and if indicated, investigation of MUC1, of the Bcl family (Bcl-2, bax, Bcl-X and Bag-1), and the tubulin isoforms (II, III, IV and Tau) were planned to be done.Socio-economic study: Patient self-completion of productivity and time loss questionnaire in 3 countries (Canada, Germany and USA), which was not analyzed.

Study H3E-MC-JMHO (JMHO) is a Phase 3, global, multicenter, randomized, open-label study of approximately 1820 patients with ED-SCLC. Eligible patients will be randomly assigned to receive either pemetrexed plus carboplatin (experimental treatment, Arm A) or etoposide plus carboplatin (control treatment, Arm B). Randomization factors include Eastern Oncology Cooperative Group (ECOG) performance status, lactate dehydrogenase (LDH), number of metastases, history of brain metastases, age, gender, and investigative center. The primary endpoint of this study was overall survival (OS). Note, due to the study stopping early prior to completion of enrollment, the number of patients randomized is less than the number planned 1820 patients (910 patient per Arm). Hence there are 455 patients in the database for Control arm.

Patients previously treated with one to two chemotherapy regimens (including one platinum-based regimen) for recurrent NSCLC, and for whom erlotinib was indicated, were randomly assigned (1:1) to sunitinib 37.5 mg/d plus erlotinib 150 mg/d or to placebo plus erlotinib 150 mg/d, stratified by prior bevacizumab use, smoking history, and epidermal growth factor receptor expression.

This double-blind, phase III study aimed to demonstrate that sunitinib plus FOLFIRI (fluorouracil, leucovorin, and irinotecan) was superior to placebo plus FOLFIRI in previously untreated metastatic colorectal cancer

Randomized, phase 3 clinical trial comparing the efficacy and safety of the combination capecitabine plus sunitinib with capecitabine in patients with advanced breast cancer. Patients eligible for this study will have previously received treatment with an anthracycline and a taxane in the adjuvant or advanced disease setting; if the disease-free interval was longer than 12 months following adjuvant therapy, patients must have received treatment with 1 chemotherapy regimen in the first-line advanced disease setting. Patients having HER2 positive disease will be eligible if they have previously received HER-2 targetted treatment as appropriate. Randomization will be stratified according to the number of metastatic organ systems (??2 vs >2 sites), receptor status (triple negative (HER2-/ER-/PR-) vs all others), and number of prior chemotherapy regimens (1 vs >1).

Randomized, open-label, Phase 3 clinical trial comparing the efficacy and safety of paclitaxel in combination with sunitinib vs paclitaxel in combination with bevacizumab as first-line treatment in subjects with advanced breast cancer. Subjects were randomly assigned (1:1) to either paclitaxel+sunitinib (Arm A) or paclitaxel+bevacizumab (Arm B). The randomization was stratified according to the following known prognostic factors: prior adjuvant chemotherapy, hormone receptor status, and disease free interval.

Phase III trial comparing the efficacy and safety of sunitinib malate versus capecitabine monotherapy in subjects with advanced breast cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for whom further anthracycline therapy is not indicated. The primary endpoint was progression-free survival (PFS) of subjects receiving sunitinib at a starting dose of 37.5 mg orally once daily compared to those recieiving capecitabine at a dose of 1250 or 1000 (in patients older than 65 years) mg/m2 twice a day for 2 consecutive weeks, followed by a 1-week rest period and given as 3 weeks cycles.

This is a controlled, randomized, multicenter, Phase III study to evaluate the safety/tolerability and anti-tumor effect of intravenously administered ABI-007/carboplatin combination therapy compared to that of Taxol/carboplatin combination therapy as first-line therapy in patients with NSCLC.

Primary myelofibrosis (PMF) is a chronic myeloproliferative disorder characterized by a clonal proliferation involving pluripotent hematopoietic stem cells and clonal cell-derived cytokines. PMF usually affects patients with advanced age but reports on young people do exist. Current approved drug therapy for PMF such as erythropoiesis stimulating agents or hydroxyurea have not been shown to influence survival and are often used for palliative purposes only. SAR302503 (previously referred to as TG101348) is a protein kinase inhibitor, selective JAK2 inhibitor, which is being developed as an orally available treatment for MF.

Previous results suggest that larotaxel may provide an additional therapeutic option for patients with pancreatic carcinoma maintaining a good performance status while progressing under gemcitabine-containing chemotherapy. It is therefore proposed to investigate larotaxel in pancreas cancer failing after a gemcitabine-based therapy as a treatment option for APC.

This is a controlled, randomized, multicenter, open label, phase III study to evaluate the safety/tolerability and anti-tumor effect of intravenously administered ABI-007 compared to that of TAXOL in patients with metastatic breast cancer. Patients who received anthracycline prior to study enrollment must have a four week interval between last dose of anthracycline and starting study drug. Within each country, patients will be randomized separately according to whether they have or have not received prior therapy with anthracyclines. Patients will receive either ABI-007 or TAXOL for up to 6 cycles. In addition, patients who complete 6 cycles of therapy and do not have progressive disease will be able to continue their arm of treatment (ABI-007 or TAXOL) at the investigator's discretion, provided the withdrawal criteria as defined in Section 3.3.4 have not been met. All patients who were randomized and received at least one dose of ABI-007 or TAXOL will be included in the intent to treat population and will be evaluated for efficacy. All patients in the intent to treat population will be assessed every month for the first three months after completion/withdrawal from this study and then every three months thereafter for survival and time to disease progression.

The purpose of this trial is to study the effect of adjuvant or immediate hormonal therapy, versus placebo, in subjects who have either undergone a primary therapy (principally radical prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting. Study Design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment

The purpose of this trial is to study the effect of adjuvant or immediate hormonal therapy, versus placebo, in subjects who have either undergone a primary therapy (principally radical prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting. Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment

The purpose of this trial is to study the effect - in terms of time to progression and overall survival - of 2 years of adjuvant bicalutamide 150mg monotherapy, versus placebo, in subjects with histologically or cytologically confirmed non-metastatic adenocarcinoma of the prostate gland. Study Design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment

This dataset was used as validation data for the Prostate Cancer DREAM Challenge. To view the curated training dataset, which includes 3 mCRPC datasets from ProjectDataSphere.org, visit: https://www.projectdatasphere.org/projectdatasphere/html/content/149

Enthuse M1C is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in combination with docetaxel (Taxotere) in patients with metastatic hormone resistant prostate cancer (HRPC). This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can further improve survival compared with docetaxel alone. ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin A receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer patients with bone metastases compared with docetaxel. All patients participating in this clinical trial will receive docetaxel chemotherapy, which is a commonly used chemotherapy to treat prostate cancer in addition to other existing prostate cancer therapies. Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to docetaxel and other prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may further slow the progression of the tumour. No patients will be deprived of standard prostate cancer therapy. Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment

Enthuse M0 is a large phase III clinical trial studying the efficacy of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC). This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve progression-free survival and overall survival against a background of existing prostate cancer treatments. ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC) patients who have had rising PSA after surgical or medical castration but have no evidence of metastases. All patients participating in this clinical trial will receive existing prostate cancer treatments in addition to trial therapy. Half the patients will receive ZD4054 (Zibotentan) , and half the patients will receive placebo in addition to standard prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may slow the progression of the tumour. No patients will be deprived of standard prostate cancer therapy. Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment

This dataset was included in the Prostate Cancer Tumor Growth data cited in The Lancet Oncology manuscript: Estimation of tumour regression and growth rates during treatment in patients with advanced prostate cancer. To view the consolidated Prostate Cancer Tumor Growth data, visit: https://www.projectdatasphere.org/projectdatasphere/html/content/167

This was a Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled study conducted at 147 sites in the U.S., Europe, Australia, and Canada comparing the efficacy and safety of abiraterone acetate and prednisone with placebo and prednisone in men with mCRPC whose disease had progressed on or after 1 or 2 chemotherapy regimens (at least one of which contained the taxane docetaxel). Planned enrollment was approximately 1,158 subjects. Subjects were stratified according to baseline Eastern Cooperative Oncology Group (ECOG) performance status score (0-1 versus 2), worst pain over the past 24 hours on the Brief Pain Inventory - Short Form (BPI-SF) (0-3 [absent] versus 4-10 [present]), 1 versus 2 prior chemotherapy regimens, and type of progression (PSA progression only versus radiographic progression with or without PSA progression) and were then randomly assigned in a 2:1 ratio to receive abiraterone acetate and prednisone or placebo and prednisone, respectively. Eligible subjects received abiraterone acetate 1 g (administered as 4 x 250-mg tablets) or 4 matching placebo tablets orally once daily continuously at least 1 hour before or 2 hours after a meal, and prednisone 5 mg orally twice daily. In regions where prednisone was not marketed, prednisolone was provided. The study consisted of a screening period (within 14 days prior to Cycle 1 Day 1), treatment period (until documented disease progression or unacceptable toxicity), and a follow-up period (follow-up for survival every 3 months up to 60 months [5 years]). While treatment was administered on a continuous schedule, each cycle of treatment was 28 days. Safety and dosing compliance were evaluated during the Cycle 1 Day 15 visit, on Day 1 of each subsequent cycle, at treatment discontinuation if applicable, and at the end-of-study visit.

This dataset was included in the Prostate Cancer Tumor Growth data cited in The Lancet Oncology manuscript: Estimation of tumour regression and growth rates during treatment in patients with advanced prostate cancer. To view the consolidated Prostate Cancer Tumor Growth data, visit: https://www.projectdatasphere.org/projectdatasphere/html/content/167

This is a 2-part, open-label (all people know the identity of the intervention) multicenter (when more than 1 hospital or medical school team work on a medical research study), Phase 2 study of the safety and efficacy of the combination of siltuximab plus mitoxantrone versus mitoxantrone in participants with metastatic HRPC who have received 1 prior Docetaxel-based chemotherapy (treatment of disease, usually cancer, by chemical agents) regimen (pattern of giving treatment). Part 1 of the study is single arm where participants will receive mitoxantrone, prednisone and siltuximab. Part 2 of the study is randomized portion (the study drug is assigned by chance), consisting of 2-arms. The experimental arm will consist of treatment with mitoxantrone, prednisone and siltuximab. The control arm will consist of treatment with mitoxantrone and prednisone. Mitoxantrone will be administered at a dose of 12 milligram per meter square (mg/m^2) intravenously (into a vein) as a 30 minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle, until disease progression or unacceptable toxicity (any harmful effect of a drug) or up to 10 cycles (a maximum total dose of approximately 120 mg/m^2). Siltuximab will be administered at a dose of 6 mg/kilogram intravenously as a 2 hour infusion, starting Day 1 of Cycle 1 to continue every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year. All participants will receive prednisone 5 mg twice daily starting with the first administration of Mitoxantrone. The duration of treatment will be a maximum of 12 months for cumulative dose. Radiologic assessments will be performed on Week 12 after the first study agent dosing, then every 9 weeks until the end of treatment and then once every 3 months until documented disease progression. Tumor (a mass in a specific area) response will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

This dataset was part of the training data curated for the Prostate Cancer DREAM Challenge. To view the curated training dataset, which includes 3 mCRPC datasets from ProjectDataSphere.org, visit: <a href='https://www.projectdatasphere.org/projectdatasphere/html/content/149'>https://www.projectdatasphere.org/projectdatasphere/html/content/149</a><br><br>This dataset was included in the Prostate Cancer Tumor Growth data cited in The Lancet Oncology manuscript: Estimation of tumour regression and growth rates during treatment in patients with advanced prostate cancer. To view the consolidated Prostate Cancer Tumor Growth data, visit: <a href='https://www.projectdatasphere.org/projectdatasphere/html/content/167'>https://www.projectdatasphere.org/projectdatasphere/html/content/167</a><br><br>The primary objective of this study is: - To evaluate the effect of DN-101 in combination with docetaxel (ASCENT regimen) on survival in metastatic androgen-independent prostate cancer The secondary objectives of this study are: - To determine the effect of the ASCENT regimen on the rate of thromboembolic events (blood clots) - To determine the effect of the ASCENT regimen on prevention of skeletal-related events (fractures) - A Separate sub-study will be conducted at selected study sites in North America to determine the population PK of DN-101.

This is a randomised, blinded trial to evaluate the clinical benefit of BAY 43-9006 400 mg bid (2x200 mg tablets) when added to Best Supportive Care in patients with unresectable, and/or metastatic RCC (Motzer "intermediate" or "low" risk) who have received one prior systemic anticancer treatment. For this trial, Best Supportive Care is defined as standard elements of care for the patient with advanced cancer; (including analgesics, nutritional support, and other non-anti neoplastic interventions), as per prevailing standards at the clinical center. Concomitant treatment with other cytotoxic or cytostatic agents is prohibited. All patients who meet the entrance criteria will be randomised to receive either BAY 43-9006 400 mg (2x200mg tablets) or matching placebo (orally) administered twice daily in combination with Best Supportive Care. Please see protocol for further details.

This dataset was part of the training data curated for the Prostate Cancer DREAM Challenge. To view the curated training dataset, which includes 3 mCRPC datasets from ProjectDataSphere.org, visit: https://www.projectdatasphere.org/projectdatasphere/html/content/149

This dataset was included in the Prostate Cancer Tumor Growth data cited in The Lancet Oncology manuscript: Estimation of tumour regression and growth rates during treatment in patients with advanced prostate cancer. To view the consolidated Prostate Cancer Tumor Growth data, visit: https://www.projectdatasphere.org/projectdatasphere/html/content/167

The combination regimen of docetaxel / prednisone is the standard of care for the treatment of Metastatic Androgen Independent Prostate Cancer (MAIPC). However, this treatment is not curative, and thus new therapeutic options for patients with this disease are still desperately needed. Induction of new blood vessels is required for expansive prostate tumor growth, and upregulation of VEGF has been shown to be inversely correlated with survival. Therefore, VEGF is a legitimate target, and it is hypothesized that the addition of a VEGF inhibitor to standard treatment will improve overall survival of MAIPC patients. Aflibercept has a high affinity for binding VEGF and other related pro-angiogenic factors. In vivo preclinical models showed an additive activity of aflibercept / taxane combination and dose response activity was observed in human prostate cancer model. Furthermore, convincing clinical evidence in support of VEGF blockade approach demonstrated in randomized studies, may be independent of tumor type.

Therefore, the present randomized placebo-controlled study has been designed to evaluate the efficacy and safety of the addition of aflibercept at the dose of 6mg/kg to the registered doses of docetaxel/prednisone in the first-line treatment of patients with MAIPC. Stratification will be done according to Eastern Cooperative Oncology Group Performance Status (ECOG PS) (0-1 vs 2). Overall survival will be the primary efficacy endpoint, which will be analyzed after approximately 873 patients have died.

This dataset was included in the Prostate Cancer Tumor Growth data cited in The Lancet Oncology manuscript: Estimation of tumour regression and growth rates during treatment in patients with advanced prostate cancer. To view the consolidated Prostate Cancer Tumor Growth data, visit: https://www.projectdatasphere.org/projectdatasphere/html/content/167

Promising results have been reported with Docetaxel in Hormone Refractory Prostate Cancer (HRPC) in terms of i) objective response in measurable lesions, ii) palliative response (pain relief, analgesic intake, symptom control), iii) PSA decline of more than 50%. These results which compared favorably with data from other cytotoxic combinations reported thus far should now be confirmed and further prospectively investigated through a multicenter randomized phase III trial.

This dataset was included in the Prostate Cancer Tumor Growth data cited in The Lancet Oncology manuscript: Estimation of tumour regression and growth rates during treatment in patients with advanced prostate cancer. To view the consolidated Prostate Cancer Tumor Growth data, visit: https://www.projectdatasphere.org/projectdatasphere/html/content/167

This was a randomized (2:1), multicenter, double-blind, placebo-controlled, Phase 3 clinical trial evaluating the efficacy and safety of sunitinib + prednisone (SP) versus placebo+prednisone (PP) in subjects with CRPC whose disease failed treatment with a docetaxel-based chemotherapy regimen.

This dataset was included in the Prostate Cancer Tumor Growth data cited in The Lancet Oncology manuscript: Estimation of tumour regression and growth rates during treatment in patients with advanced prostate cancer. To view the consolidated Prostate Cancer Tumor Growth data, visit: https://www.projectdatasphere.org/projectdatasphere/html/content/167

Based on a very good pre-clinical activity, a favorable safety profile in addition to the early activity observed in prostate cancer and taxane resistant Metastatic Breast Cancer (MBC) patients, it was hypothesized that cabazitaxel in combination with prednisone may prolong survival in prostate cancer patients that failed a docetaxel containing regimen.