drugset / Trial / NCT00623805
A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) as Maintenance Treatment in Patients With Metastatic Colorectal Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |