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Lung (Small Cell)

Combination Chemotherapy With or Without Maintenance Sunitinib Malate (NSC 736511) For Untreated Extensive Stage Small Cell Lung Cancer: A Phase IB/Randomized Phase II Study

Unique Dataset IDLungSm_Allianc_2007_218
DownloadableYes
SponsorAlliance for Clinical Trials in OncologyData ProviderThe Alliance for Clinical Trials in OncologyTotal Study Enrolled Patients144Comparator (Control) Arm Enrolled Patients46Experimental (Active) Arm Enrolled Patients49RandomizationYesClinicalTrial.gov IDNCT00453154ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/record/NCT00453154?term=CALGB+30504&rank=1
Study PhaseClinical Study Phase IIBBlinding MethodDouble-BlindedType(s) of dataBoth comparator and experimental arm dataIntervention TypeDrug, PlaceboDataset TypeADS

Clinical Trial Title

Combination Chemotherapy With or Without Maintenance Sunitinib Malate (NSC 736511) For Untreated Extensive Stage Small Cell Lung Cancer: A Phase IB/Randomized Phase II Study

Trial Summary and Conditions

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.

Data Summary

Control and experimental arm data files include data on safety, efficacy, demographics, etc. See the data dictionary provided for complete details.

Study Objectives

Phase IB: To determine the phase II dose for sunitinib combined with cisplatin and etoposide. Phase II: To compare the progression-free survival of patients with extensive stage small cell lung cancer treated with cisplatin or carboplatin and etoposide followed by maintenance sunitinib to patients receiving the same chemotherapy followed by placebo. See protocol for further details.

Outcome Measures

Maximum Tolerated of Sunitinib Combined With Cisplatin and Etoposide (Phase I) [ Time Frame: 21 days ] Progression-free Survival (Phase II) [ Time Frame: Up to 3 years ]

Available Downloads:

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

PROTOCOL: C30504-13.pdf

CRF: C30504-Allforms.pdf

DATA DICTIONARY: c30504_dd.docx

DATA (BOTH COMPARATOR AND ACTIVE ARMS): ae.csv

DATA (BOTH COMPARATOR AND ACTIVE ARMS): clinical.csv