Conditions: Gastric Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 202
Healthy volunteers: no

Brief summary:
This 2 arm study will compare the efficacy and safety of bevacizumab in combination with capecitabine and cisplatin versus placebo in combination with capecitabine and cisplatin in participants who have not received prior chemotherapy for advanced or metastatic gastric cancer. Participants will be randomized to one of two treatment groups Bevacizumab + Capecitabine/Cisplatin (experimental arm) or Placebo + Capecitabine/Cisplatin (control arm).

Detailed description:

Arms:
arm 1: Participants will receive bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 milligrams per square meter (mg/m\^2) orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity. arm 2: Participants will receive placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.

Interventions: intervention 1: Bevacizumab intervention 2: Placebo intervention 3: Capecitabine intervention 4: Cisplatin
Intervention descriptions: intervention 1: 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle intervention 2: Placebo matched to bevacizumab on Day 1 of every 3-week cycle intervention 3: 1000 mg/m\^2 orally twice daily on Days 1-14 of every 3-week cycle intervention 4: 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles

Protocol document: