drugset / Trial / NCT00623805

A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) as Maintenance Treatment in Patients With Metastatic Colorectal Cancer

NCT00623805 ↗

Phase 3 Completed 123 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

Summary

This 2 arm study assessed the efficacy and safety of maintenance treatment with Avastin (bevacizumab) + Xeloda (capecitabine), after initial treatment with Xeloda + oxaliplatin + Avastin, in patients with metastatic colorectal cancer. Patients were randomized into one of 2 groups to receive 1) Xeloda + oxaliplatin + Avastin until disease progression or 2) Xeloda + oxaliplatin + Avastin for 6 3-week cycles, followed by Xeloda + Avastin until disease progression. Xeloda was administered at a dose of 1000 mg/m\^2 orally twice a day on days 1-14 of each cycle, oxaliplatin at a dose of 130 mg/m\^2 intravenously (iv) on day 1 of each cycle, and Avastin at a dose of 7.5 mg/kg iv on day 1 of each cycle.

Timeline

Start
2008-03
Primary completion
2012-05
Completion
2012-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 7.5 mg/kg Intravenous
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Oxaliplatin Small molecule 130 mg/m2 Intravenous

Indications