| 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 |
| 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 |
| 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. |
| Not Provided |
| Interventional |
| Phase 2 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment |
| Colorectal Neoplasms |
- Drug: Bevacizumab (avastin)
Bevacizumab intravenous [IV] infusion 5 mg/kg every two weeks until disease progression, intolerance or withdrawal of consent.
- Drug: FOLFIRI (Irinotecan, leucovorin, 5-fluorouracil [5FU])
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.
- Drug: AG-013736 (axitinib)
Axitinib is given at a starting dose of 5 mg twice daily [BID] continuous dosing until disease progression, intolerance or withdrawal of consent.
- Drug: FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])
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.
- Drug: FOLFIRI (irinotecan, leucovorin, 5-fluorouracil [5FU])
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.
- Drug: Bevacizumab (avastin)
Bevacizumab intravenous infusion [IV] 5 mg/kg every two weeks until disease progression, intolerance or withdrawal of consent.
- Drug: FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])
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.
|
- Active Comparator: B
Bevacizumab (avastin)
Interventions:
- Drug: Bevacizumab (avastin)
- Drug: FOLFIRI (Irinotecan, leucovorin, 5-fluorouracil [5FU])
- Experimental: C
AG-013736 (axitinib)
Interventions:
- Drug: AG-013736 (axitinib)
- Drug: FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])
- Experimental: A
AG-013736 (axitinib)
Interventions:
- Drug: AG-013736 (axitinib)
- Drug: FOLFIRI (irinotecan, leucovorin, 5-fluorouracil [5FU])
- Active Comparator: D
bevacizumab (avastin)
Interventions:
- Drug: Bevacizumab (avastin)
- Drug: FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])
|
| Not Provided |
| |
| Completed |
| 171 |
| April 2012 |
| March 2011 (Final data collection date for primary outcome measure) |
|
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.
|
| Sexes Eligible for Study: |
All |
|
| 18 Years and older (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Canada, France, Italy, Japan, Korea, Republic of, Poland, Spain, United States |
| Belgium, Czech Republic |
| |
| NCT00615056 |
| A4061034 |
| No |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| April 2013 |
