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

Roche

Status and phase: Completed; Phase 3

Conditions: Gastric Cancer

Treatments: Drug: Bevacizumab; Drug: Placebo; Drug: Cisplatin; Drug: Capecitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00887822

ML22367

Details and patient eligibility

About

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).

Enrollment: 202 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction with inoperable, locally advanced or metastatic disease, not amenable to curative therapy
• Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2
• Measurable disease or non-measurable but evaluable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST)

Exclusion criteria

• Previous chemotherapy for locally advanced or metastatic gastric cancer
• Previous platinum or anti-angiogenic therapy
• Radiotherapy within 28 days of randomization
• Evidence of Central Nervous System (CNS) metastasis at baseline

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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202 participants in 2 patient groups, including a placebo group

Bevacizumab, Capecitabine and Cisplatin

Experimental group

Description:

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.

Treatment:

Drug: Cisplatin

Drug: Capecitabine

Drug: Bevacizumab

Placebo, Capecitabine and Cisplatin

Placebo Comparator group

Description:

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.

Treatment:

Drug: Cisplatin

Drug: Placebo

Drug: Capecitabine