NCTN: A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients with Advanced Transitional Cell Carcinoma (CALGB-90601)
Study ID: CALGB-90601
NCT Number: NCT00942331
Alliance for Clinical Trials in Oncology
Submitted in collaboration with the NCTN/NCORP Data Archive
Trial Title: NCTN: A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients with Advanced Transitional Cell Carcinoma (CALGB-90601)
Trial Description: This randomized phase III trial studies gemcitabine hydrochloride, cisplatin, and bevacizumab to see how well they work compared with gemcitabine hydrochloride and cisplatin in treating patients with urinary tract cancer that has spread to other places in the body. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, 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. Immunotherapy with bevacizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether gemcitabine hydrochloride and cisplatin are more effective when given with or without bevacizumab in treating patients with urinary tract cancer.
Clinical data presented in the following publication(s):
- PMID 33989025
Disease type(s): Urothelial Tract Neoplasm - Urothelial Tract/Bladder Cancer
Clinical Dataset(s) included:
- NCT00942331-D1 (PMID 33989025): Dataset NCT00942331-D1 is one of 3 datasets associated with PubMed ID 33989025. This dataset contains all patient level data including baseline characteristics, survival status and time to event, progression free survival and time to event, treatment summaries, off treatment reasons for chemotherapy and bev/placebo, best response, tumor scans, the occurrence of grade 3/4 thrombocytopenia, the occurrence of a serious adverse event, and the occurrence of a dose delay or reduction.
- NCT00942331-D2 (PMID 33989025): Dataset NCT00942331-D2 is one of 3 datasets associated with PubMed ID 33989025. This dataset contains dose modification reasons for all patients with at least one dose reduction or delay. There is also a variable distinguishing the dose modification between cisplatin and gemcitabine.
- NCT00942331-D3 (PMID 33989025): Dataset NCT00942331-D3 is one of 3 datasets associated with PubMed ID 33989025. This dataset contains adverse event information.
You are encouraged to view the PDF data dictionaries found in the “Documents” tab of the dbGaP study page, which may contain additional information regarding the data or the associated publication(s).
- Type: Double-Blind
- Archive: The database of Genotypes and Phenotypes (dbGaP)