drugset / Trial / NCT00642577
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Chinese Patients With Metastatic Colorectal Cancer.
RandomizedParallel-groupOpen-labelTreatment
Summary
This 2 arm study will assess the efficacy and safety of Avastin in combination with irinotecan + 5-fluorouracil/folinic acid, versus irinotecan + fluorouracil/folinic acid alone, as first line treatment in Chinese patients with metastatic colorectal cancer. Patients will be randomized 2:1 to receive 6-weekly cycles of Avastin (5mg/kg iv every 2 weeks) + irinotecan 125mg/m2 iv / leucovorin 20mg/m2 iv / fluorouracil 500mg/m2 iv weekly for 4 weeks, or 6-weekly cycles of irinotecan 125mg/m2 iv / leucovorin 20mg/m2 iv / fluorouracil 500mg/m2 iv weekly for 4 weeks. The anticipated time on study treatment is until disease progression, and the sample size is 100-500 individuals.
Timeline
- Start
- 2007-07
- Primary completion
- 2010-12
- Completion
- 2010-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Background | Irinotecan | Small molecule | 125 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | 20 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 500 mg/m2 | Intravenous |