774
Participants
Start Date
September 30, 2007
Primary Completion Date
November 30, 2009
Study Completion Date
November 30, 2013
Bevacizumab
Intravenous bevacizumab 7.5 mg/kg once every 3 weeks, given until disease progression or unmanageable toxicity.
Capecitabine
Oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, given until disease progression or unmanageable toxicity.
Cisplatin
Cisplatin 80 mg/m˄2 as a 2 hr intravenous infusion with hyper-hydration and pre-medication (steroids and anti-emetics), given every 3 weeks for a maximum of 6 cycles or until disease progression or unmanageable toxicity.
Placebo
Intravenous placebo every 3 weeks, given until disease progression or unmanageable toxicity.
5-fluorouracil
For participants with difficulty swallowing, malabsorption, or other conditions that could affect intake of oral capecitabine medication, 5-fluorouracil was administered instead, at a dose of 800 mg/m˄2/day as a continuous intravenous infusion over 5 days (days 1 to 5 of each cycle), every 3 weeks.
Memorial Sloan Kettering, New York
South Carolina Oncology Assoc, Columbia
Georgetown University, Washington D.C.
Duke Univ Medical Center, Durham
H. Lee Moffitt Cancer, Tampa
Florida Cancer Specialists, Fort Myers
The Sarah Cannon Research Inst, Nashville
Methodist Cancer Center Onc, Omaha
Kenmar Research Institute LLC, Los Angeles
USC/Norris Cancer Center, Los Angeles
Moores UCSD Cancer Center, La Jolla
Tower Cancer Research Fnd, Beverly Hills
Cancer Center of Kansas, Wichita
Lead Sponsor
Collaborators (1)
Hoffmann-La Roche
INDUSTRY
Chugai Pharmaceutical
INDUSTRY
Genentech, Inc.
INDUSTRY