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
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
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Axitinib + FOLFIRI vs Bevacizumab + FOLFIRI; p = 0.8268; Hazard Ratio (HR) 1.273 (95% CI 0.769 to 2.108); Log Rank NCT00615056 ↗
registry analysis (superiority or other test); Axitinib + FOLFOX vs Bevacizumab + FOLFOX; p = 0.5498; Hazard Ratio (HR) 1.041 (95% CI 0.553 to 1.041); Log Rank NCT00615056 ↗
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 |