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Type(s) of Cancer
Bladder
Study Phase
Phase 3
Study Completion Date
2018-11-02
NCT00942331Uploaded 10-11-2023
Access via NCI by Request
PDS UID: nci-data-526
A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients With Advanced Transitional Cell Carcinoma
Provider Information
Provider Data DescriptionDataset NCT00942331-D1-Dataset.csv (pt_all) 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.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis 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.
ConditionsAdvanced Urothelial Carcinoma
Metastatic Bladder Urothelial Carcinoma
Metastatic Prostate Carcinoma
Metastatic Renal Pelvis Urothelial Carcinoma
Metastatic Ureter Urothelial Carcinoma
Metastatic Urethral Urothelial Carcinoma
Metastatic Urothelial Carcinoma
Stage IV Bladder Urothelial Carcinoma AJCC v7
Stage IV Prostate Cancer AJCC v7
Stage IV Renal Pelvis Cancer AJCC v7
Stage IV Ureter Cancer AJCC v7
Stage IV Urethral Cancer AJCC v7
Unresectable Urothelial Carcinoma
Intervention TypeBiological: Bevacizumab
Drug: Cisplatin
Drug: Gemcitabine Hydrochloride
Other: Laboratory Biomarker Analysis
Other: Placebo Administration
Drug(s)Drug: Cisplatin
Drug: Gemcitabine Hydrochloride
Total Enrolled506
RandomizationRandomized
Blinding MethodDouble
Arms InterventionArm I (gemcitabine hydrochloride, cisplatin, placebo) - Active Comparator
Arm II (gemcitabine hydrochloride, cisplatin, bevacizumab) - Experimental
Secondary IDNCI-2011-01952
PubMed (PMID)33989025
Collaborator(s)N/A
Region(s)United States
Puerto Rico
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT00942331-D1
Data DictionaryNCT00942331-D1-Data-Dictionary_0.pdf
DATANCT00942331-D1-Dataset_0.csv
OTHERREADME.pdf
Files: NCT00942331-D2
Data DictionaryNCT00942331-D2-Data-Dictionary_0.pdf
DATANCT00942331-D2-Dataset_0.csv
OTHERREADME.pdf
Files: NCT00942331-D3
Data DictionaryNCT00942331-D3-Data-Dictionary_0.pdf
DATANCT00942331-D3-Dataset_0.csv
OTHERREADME.pdf
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