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Colorectal

PACCE: A Randomized, Open-Label, Controlled, Clinical Trial of Chemotherapy and Bevacizumab With and Without Panitumumab in the First-Line Treatment of Subjects With Metastatic Colorectal Cancer

Unique Dataset IDColorec_Amgen_2005_262
DownloadableYes
SponsorAmgenData ProviderAmgenTotal Study Enrolled Patients1053Comparator (Control) Arm Enrolled Patients525Experimental (Active) Arm Enrolled Patients528RandomizationYesClinicalTrial.gov IDNCT00115765ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00115765?term=20040249&rank=1
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataBoth comparator and experimental arm dataIntervention TypeChemotherapy, Targeted Therapy, BiologicsDataset TypeADS

Clinical Trial Title

PACCE: A Randomized, Open-Label, Controlled, Clinical Trial of Chemotherapy and Bevacizumab With and Without Panitumumab in the First-Line Treatment of Subjects With Metastatic Colorectal Cancer

Trial Summary and Conditions

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.

Data Summary

Control arm and experimental arm data including demographics, disease characteristics, safety and efficacy

Study Objectives

Primary Objective - To assess whether treatment with panitumumab given concomitantly with every 2 (Q2) week oxaliplatin-based chemotherapy and bevacizumab improves progression- free survival (PFS) compared to treatment with Q2-week oxaliplatin-based chemotherapy and bevacizumab alone. • Secondary Objectives - To assess 1) Whether treatment with panitumumab given concomitantly with oxaliplatin-based chemotherapy and bevacizumab improves the following endpoints compared to treatment with oxaliplatin-based chemotherapy and bevicizumab alone: Overall Survival; Response rates (complete [CR] and partial [PR] responses [at week 12 and best overall response during 1st line treatment]); Time to progression (TTP); Time to treatment failure (TTF); Duration of response and Rate of stable disease (SD) and duration of SD. 2) The safety of panitumumab given concomitantly with oxaliplatin-based chemotherapy and bevicizumab as compared to treatment of oxaliplatin-based chemotherapy and bevicizumab alone and 3) The safety and efficacy of panitumumab given concomitantly with irinotecan-based chemotherapy and bevicizumab as compared to treatment of irinotecan-based chemotherapy and bevicizumab alone.

Outcome Measures

Primary Outcome Measures : 1. Progression-Free Survival (Oxaliplatin) 2. Objective Tumor Response Through Week 12 (Irinotecan) Secondary Outcome Measures : 1. Overall Survival (Oxaliplatin) 2. Objective Tumor Response Rate (Oxaliplatin) 3. Time to Progression (Oxaliplatin) 4. Time to Treatment Failure (Oxaliplatin) 5. Overall Survival (Irinotecan) 6. Progression-free Survival (Irinotecan) 7. Objective Tumor Response Rate (Irinotecan) 8. Time to Progression (Irinotecan) 9. Time to Treatment Failure (Irinotecan)

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: 20040249_01.20.01 Protocol Amend 2 2007-08-07 English_Redacted.pdf

CRF: Amgen 20040249 CRF REDACTED.pdf

DATA DICTIONARY: Amgen 20040249 DDT.pdf

DATA (BOTH COMPARATOR AND ACTIVE ARMS): SAS dataset - 20040249.zip