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Type(s) of Cancer
Lung
Study Phase
Phase 1Phase 2
Study Completion Date
2013-06-30
NCT00453154Uploaded 03-30-2023
Access via NCI by Request
PDS UID: nci-data-512
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
Provider Information
Provider Data DescriptionNCT00453154-D1-Dataset.csv (ae) is one of 2 datasets associated with PubMed ID 25732163. This dataset contains information for the adverse events reported in the manuscript.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis 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.
ConditionsExtensive Stage Lung Small Cell Carcinoma
Recurrent Lung Small Cell Carcinoma
Intervention TypeDrug: Carboplatin
Drug: Cisplatin
Drug: Etoposide
Other: Laboratory Biomarker Analysis
Other: Placebo Administration
Drug: Sunitinib Malate
Drug(s)Drug: Carboplatin
Drug: Cisplatin
Drug: Etoposide
Drug: Sunitinib Malate
Total Enrolled156
RandomizationRandomized
Blinding MethodDouble
Arms InterventionArm I (Combination Chemotherapy + Sunitinib Maintenance) - Experimental
Arm II (Combination Chemotherapy + Placebo Maintenance) - Active Comparator
Secondary IDNCI-2009-00465
PubMed (PMID)25732163
Collaborator(s)N/A
Region(s)United States
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT00453154-D1
Data DictionaryNCT00453154-D1-Data-Dictionary_1.pdf
DATANCT00453154-D1-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00453154-D2
Data DictionaryNCT00453154-D2-Data-Dictionary_1.pdf
DATANCT00453154-D2-Dataset_1.csv
OTHERREADME.pdf
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