A Study of Bevacizumab in Combination With Capecitabine and Cisplatin as First-line Therapy in Patients With Advanced Gastric Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

774

Participants

Timeline

Start Date

September 30, 2007

Primary Completion Date

November 30, 2009

Study Completion Date

November 30, 2013

Conditions
Adenocarcinoma
Interventions
DRUG

Bevacizumab

Intravenous bevacizumab 7.5 mg/kg once every 3 weeks, given until disease progression or unmanageable toxicity.

DRUG

Capecitabine

Oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, given until disease progression or unmanageable toxicity.

DRUG

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.

DRUG

Placebo

Intravenous placebo every 3 weeks, given until disease progression or unmanageable toxicity.

DRUG

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.

Trial Locations (13)

10021

Memorial Sloan Kettering, New York

10595

South Carolina Oncology Assoc, Columbia

20007

Georgetown University, Washington D.C.

27710

Duke Univ Medical Center, Durham

33612

H. Lee Moffitt Cancer, Tampa

33916

Florida Cancer Specialists, Fort Myers

37203

The Sarah Cannon Research Inst, Nashville

68114

Methodist Cancer Center Onc, Omaha

90057

Kenmar Research Institute LLC, Los Angeles

90089

USC/Norris Cancer Center, Los Angeles

92093

Moores UCSD Cancer Center, La Jolla

90211-1850

Tower Cancer Research Fnd, Beverly Hills

67214-3728

Cancer Center of Kansas, Wichita

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Hoffmann-La Roche

INDUSTRY

collaborator

Chugai Pharmaceutical

INDUSTRY

lead

Genentech, Inc.

INDUSTRY