Trial information
A Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) and Cisplatin in Patients With Advanced Gastric Cancer.
Status: Recruiting
Protocol number: BO20904
Sponsor: Hoffmann-La Roche; Genentech Inc.; Chugai Pharmaceutical Co. ltd
Company division: Pharmaceutical
Official Scientific Title: A randomized, double-blind study comparing the effect of first-line therapy with Avastin or placebo, in combination with Xeloda and cisplatin, on overall survival in patients with advanced gastric cancer.
Brief summary: This study will compare the efficacy and safety of Xeloda and cisplatin in combination with Avastin or placebo in patients with advanced gastric cancer who have received no prior treatment for advanced or metastatic gastric cancer. Patients will be randomized to receive 3-weekly cycles of Xeloda 1000mg/m2 p.o. b.i.d. plus cisplatin 80mg/m2 in combination with either Avastin 7.5mg/kg i.v. or placebo i.v. After a maximum of 6 cycles of oxaliplatin, patients can continue with Xeloda and Avastin or monotherapy with either drug, depending on the toxicity experienced by the patient. Throughout the study, safety will be monitored by an independent data and safety monitoring board. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals. In the US this study is sponsored/managed by Genentech, under protocol no. AVF4200g. Target sample size is 760.
Study phase: III
Study type: Interventional; Treatment; Randomized; Double Blind; Active; Parallel; Safety/Efficacy study
Condition: Gastric Cancer
Intervention type: Drug
Intervention name: bevacizumab[Avastin]
Primary outcome: 1. Overall survival.
Key secondary outcomes: 1. Efficacy: Progression-free survival, time to progression, overall response rate, duration of response, disease control rate. Safety: AEs, laboratory parameters.
Inclusion criteria:
- adult patients, >=18 years of age;
- inoperable, locally advanced or metastatic cancer of stomach or gastro-esophageal junction;
- measurable or non-measurable but evaluable disease;
- ERCOG PS of 0, 1 or 2.
Exclusion criteria:
- previous chemotherapy for locally advanced or metastatic gastric cancer;
- previous platinum or anti-angiogenic therapy;
- patients with locally advanced disease who are candidates for curative therapy;
- radiotherapy within 28 days of randomisation;
- evidence of CNS metastasis;
- inadequate organ function;
- history of bleeding or wound-healing complications.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: September, 2007
Trial registration date: 07/19/2007
Date last updated: 9/29/2008
Link to trial result
This trial is being conducted at the following locations:
Australia
- Adelaide
- Heidelberg
- Melbourne
- Sydney
Belgium
Brazil
- Barretos
- Fortaleza
- Goiania
- Jaú
- Porto Alegre
- Rio De Janeiro
- Salvador
- Sao Paulo
- Sorocaba
China
Costa Rica
France
- Brest
- Colmar
- Nantes
- Reims
Germany
- Halle
- Hannover
- Mainz
- Mannheim
- Tübingen
- Ulm
Italy
- Ancona
- Aviano
- Firenze
- Genova
- Milano
- Roma
- Udine
Japan
- Aichi
- Chiba
- Ehime
- Hokkaido
- Kanagawa
- Osaka
- Saitama
- Shizuoka
- Tochigi
- Tokyo
Peru
Russian Federation
- Ivanovo
- Kazan
- Moscow
- Omsk
- Rostov-Na-Donu
- Ryazan
- Samara
- Saratov
- St Petersburg
- Ufa
Singapore
Spain
- Barcelona
- Madrid
- Santander
Taiwan
United Kingdom
- Bristol
- Denbigh
- Wolverhampton
United States
- Beverly Hills, CA
- La Jolla, CA
- Los Angeles, CA
- Washington, DC
- Bonita Springs, FL
- Bradenton, FL
- Cape Coral, FL
- Englewood, FL
- Fort Myers, FL
- Naples, FL
- Port Charlotte, FL
- Sarasota , FL
- Tampa, FL
- Venice, FL
- Wichita, KS
- Omaha, NE
- New York, NY
- Durham, NC
- Columbia, SC
- Nashville, TN
