Double-Blind, Randomised, Multicenter, Phase III Study of Bevacizumab in Combination With Capecitabine and Cisplatin Versus Placebo in Combination With Capecitabine and Cisplatin, As First-Line Therapy in Patients With Advanced Gastric Cancer
This was a two arm, randomized, double-blind, multicenter phase III study. Patients were
randomized (1:1) to capecitabine/cisplatin plus bevacizumab or capecitabine/cisplatin plus
placebo. This was an event-driven trial with the final analysis (triggering the end of the
study) planned after approximately 517 deaths had been observed. After final analysis the
study will remain open and patients can continue with study treatment until progressive
disease or earlier at the investigators discretion. After discontinuation of the last
patient, the study will end globally.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Overall Survival
The primary efficacy endpoint for this study was overall survival (time to death), defined as the time between randomization and the date of death irrespective of the cause of death. Patients for whom no death was captured on the clinical database were censored at the most recent date they were known to be alive. Median survival was estimated by the Kaplan-Meier method.
From randomization until death, up to 26 months
No
Eric Hedrick, M.D.
Study Director
Genentech
United States: Food and Drug Administration
AVF4200g
NCT00548548
September 2007
Name | Location |
---|---|
Florida Cancer Specialists | Fort Myers, Florida 33901 |
Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
Georgetown University | Washington, District of Columbia 20007-2197 |
USC/Norris Cancer Center | Los Angeles, California |
Cancer Center of Kansas | Wichita, Kansas 67214 |
Memorial Sloan Kettering | New York, New York 10021 |
South Carolina Oncology Assoc | Columbia, South Carolina 29210 |
Kenmar Research Institute LLC | Los Angeles, California 90057 |
Tower Cancer Research Fnd | Beverly Hills, California 90211-1850 |
H. Lee Moffitt Cancer | Tampa, Florida 33612 |
Methodist Cancer Center Onc | Omaha, Nebraska 68114 |
Duke Univ Medical Center | Durham, North Carolina 27710 |
The Sarah Cannon Research Inst | Nashville, Tennessee 37203 |