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

NCT00887822 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2017-03-01

Study results available
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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).

Conditions

Interventions

DRUG

Bevacizumab

7.5 mg/kg IV infusion on Day 1 of every 3-week cycle

DRUG

Placebo

Placebo matched to bevacizumab on Day 1 of every 3-week cycle

DRUG

Capecitabine

1000 mg/m\^2 orally twice daily on Days 1-14 of every 3-week cycle

DRUG

Cisplatin

80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-05-31
Completion
2014-08-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00887822 on ClinicalTrials.gov