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
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Intervention: Bevacizumab (avastin); FOLFIRI (Irinotecan, leucovorin, 5-fluorouracil [5FU]); AG-013736 (axitinib); FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU]); AG-013736 (axitinib); FOLFIRI (irinotecan, leucovorin, 5-fluorouracil [5FU]); Bevacizumab (avastin); FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])
Intervention description: 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.
Intervention MeSH terms: Leucovorin; Bevacizumab; Fluorouracil; Oxaliplatin; Irinotecan; Axitinib; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 171.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically documented colorectal cancer plus one of the following:

          -  Failure of one prior irinotecan- or oxaliplatin-containing regimen, or

          -  Adjuvant refractory to irinotecan- or oxaliplatin-containing regimen.

        Exclusion Criteria:

          -  Prior treatment in first line metastatic setting with more than one regimen

          -  Prior irradiation of more than 25% of bone marrow.