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

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Disease Information

Descriptive Information
Brief Title † A Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) and Cisplatin as First-Line Therapy for Advanced Gastric Cancer
Official Title † A Double-blind, Randomised, Multicenter, Phase III Study of Bevacizumab in Combination With Capecitabine and Cisplatin Versus Placebo in Combination With Capecitabine and Cisplatin, as First-line Therapy in Chinese Patients With Advanced Gastric Cancer.
Brief Summary This 2 arm study will compare the efficacy and safety of Avastin versus placebo, in combination with Xeloda and cisplatin, in patients who have received no prior treatment for advanced or metastatic gastric cancer. Patients will be randomized to receive either Avastin 7.5mg/kg iv or placebo iv, in combination with Xeloda 1000mg/m2 po bid on days 1-14 of each 3 week cycle, and cisplatin 80mg/m2 every 3 weeks. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Detailed Description
Study Phase Phase 3
Study Type † Interventional
Study Design † Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary Outcome Measure † Overall survival
Secondary Outcome Measure † Progression-free survival; time to progression; overall response rate; duration of response
Condition † Gastric Cancer
Intervention † DrugPlacebo
Study Arms / Comparison Groups 1 2
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 202
Start Date † March 2009
Completion Date August 2014
Primary Completion Date August 2014
Eligibility Criteria † Inclusion Criteria: - adult patients, >=18 years of age; - histologically confirmed cancer of the stomach or gastro-oesophageal junction; - inoperable, locally advanced or metastatic disease, not amenable to curative therapy; - ECOG PS of 0,1 or 2. Exclusion Criteria: - previous chemotherapy for locally advanced or metastatic gastric cancer; - previous platinum or anti-angiogenic therapy; - radiotherapy within 28 days of randomisation; - evidence of CNS metastasis at baseline.
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † China
Administrative Information
NCT ID † NCT00887822
Organization ID ML22367
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Hoffmann-La Roche
Collaborators ††
Investigators † Study Director: Clinical Trials, Hoffmann-La Roche
Information Provided By
Verification Date October 2015
First Received Date † April 22, 2009
Last Updated Date October 1, 2015
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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