At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Phase 2 Study Of FOLFOX Or FOLFIRI With AG-013736 Or Bevacizumab (Avastin) In Patients With Metastatic Colorectal Cancer After Failure Of An Irinotecan Or Oxaliplatin-Containing First-Line Regimen
In Brief
A Phase 2 clinical trial evaluating Bevacizumab (avastin), FOLFIRI (Irinotecan, leucovorin, 5-fluorouracil [5FU]), and 3 other interventions for Colorectal Neoplasms. Completed, enrolled 171 participants across 83 sites in 8 countries.
Detailed 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.
Study Details
Timeline
Interventions
Bevacizumab intravenous \[IV\] infusion 5 mg/kg every two weeks until disease progression, intolerance or withdrawal of consent.
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.
Axitinib is given at a starting dose of 5 mg twice daily \[BID\] continuous dosing until disease progression, intolerance or withdrawal of consent.
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.
Axitinib is given at a starting dose of 5 mg twice daily \[BID\] continuous dosing until disease progression, intolerance or withdrawal of consent.
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.
Bevacizumab intravenous infusion \[IV\] 5 mg/kg every two weeks until disease progression, intolerance or withdrawal of consent.
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.