A Study of Bevacizumab (Avastin) Versus Placebo in Combination With Capecitabine (Xeloda) and Cisplatin as First-Line Therapy for Advanced Gastric Cancer

Sponsor
Hoffmann-La Roche
Study ID
NCT00887822
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

First listed
Apr 24, 2009
Start date
Mar 31, 2009
Status verified
Jan 2017
Primary completion
May 31, 2011
Completion
Aug 31, 2014

Study Design

Enrollment
202 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab, Capecitabine and Cisplatin
    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.
  • Placebo Comparator: Placebo, Capecitabine and Cisplatin
    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.

Primary Outcome Measure

Percentage of Participants With Event (Death) [ Time Frame: From randomization until death (up to 34 months) ]

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