Conditions: Colorectal Neoplasms
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 171
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Bevacizumab (avastin) arm 2: AG-013736 (axitinib) arm 3: AG-013736 (axitinib) arm 4: bevacizumab (avastin)

Interventions: intervention 1: Bevacizumab (avastin) intervention 2: FOLFIRI (Irinotecan, leucovorin, 5-fluorouracil [5FU]) intervention 3: AG-013736 (axitinib) intervention 4: FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU]) intervention 5: AG-013736 (axitinib) intervention 6: FOLFIRI (irinotecan, leucovorin, 5-fluorouracil [5FU]) intervention 7: Bevacizumab (avastin) intervention 8: FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])
Intervention descriptions: intervention 1: Bevacizumab intravenous \[IV\] infusion 5 mg/kg every two weeks until disease progression, intolerance or withdrawal of consent. intervention 2: Irinotecan (180 mg/m²) intravenous infusion \[IV\] over 90 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion \[IV\] over 2 hours followed immediately by 5-FU bolus (400 mg/m²) intravenous \[IV\] and a subsequent 5-FU infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent. intervention 3: Axitinib is given at a starting dose of 5 mg twice daily \[BID\] continuous dosing until disease progression, intolerance or withdrawal of consent. intervention 4: Oxaliplatin (85 mg/m²) intravenous infusion \[IV\] over 120 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion \[IV\] over 2 hours followed by 5-FU IV bolus (400 mg/m²) and a subsequent 5-FU IV infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent. intervention 5: Axitinib is given at a starting dose of 5 mg twice daily \[BID\] continuous dosing until disease progression, intolerance or withdrawal of consent. intervention 6: Irinotecan (180 mg/m²) intravenous infusion \[IV\] over 90 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion \[IV\] over 2 hours followed immediately by 5-FU bolus (400 mg/m²) IV and a subsequent 5-FU IV infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent. intervention 7: Bevacizumab intravenous infusion \[IV\] 5 mg/kg every two weeks until disease progression, intolerance or withdrawal of consent. intervention 8: Oxaliplatin (85 mg/m²) IV infusion over 120 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion \[IV\] over 2 hours followed by 5-FU IV bolus (400 mg/m²) and a subsequent 5-FU IV infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent.

Protocol document: