drugset / Trial / NCT00615056
A Study Combining FOLFOX or FOLFIRI With AG-013736 or Bevacizumab (Avastin) in Patients With Metastatic Colorectal Cancer After Failure Of One First Line Regimen
RandomizedParallel-groupOpen-labelTreatment
Summary
The study is designed to demonstrate that the combination of AG-013736 with either FOLFIRI or FOLFOX is superior to FOLFIRI or FOLFOX in combination with bevacizumab (Avastin) in delaying tumor progression in the second-line treatment of patients with metastatic colorectal cancer after failure of an irinotecan or oxaliplatin-containing first-line regimen.
Timeline
- Start
- 2008-03
- Primary completion
- 2011-03
- Completion
- 2012-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Axitinib | Small molecule | 5 mg | — |
| Comparator | Bevacizumab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | Irinotecan | Small molecule | 180 mg/m2 | Intravenous |
| Comparator | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Comparator | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Comparator | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Comparator | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |