Phase 2
N=171
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
Colorectal Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00615056 ↗Enrolled (actual)
171
Serious AEs
25.0%
Results posted
Apr 2012
Primary outcome: Primary: Progression Free Survival (PFS) — 5.72; 6.87; 7.59; 6.44 Months — p=0.8268
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bevacizumab (avastin) (Drug); FOLFIRI (Irinotecan, leucovorin, 5-fluorouracil [5FU]) (Drug); AG-013736 (axitinib) (Drug); FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU]) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
5.72; 6.87; 7.59; 6.44 | 0.8268 |
| SECONDARY Overall Survival (OS) |
12.9; 15.7; 17.1; 14.1 | 0.8828 |
| SECONDARY Percentage of Participants With Objective Response (OR) |
24.5; 23.5; 19.4; 20.0 | 0.4552 |
| SECONDARY Duration of Response (DR) |
7.52; 12.29; 10.15; 10.94 | — |
| SECONDARY Change From Baseline in MD Anderson Symptoms Inventory Diarrhea (MDASI-D) Symptom Severity Score at Day 1 of Cycles 2-5, Day 1 of Every Odd-numbered Cycle Throughout the Study and End of Treatment (Cycle 65) or Withdrawal |
2.1; 1.8; 1.9; 2.0; 0.6; 0.5 | — |
| SECONDARY Change From Baseline in MDASI-D Symptom Interference Score at Day 1 of Cycles 2-5, Day 1 of Every Odd-numbered Cycle Throughout the Study and End of Treatment (Cycle 65) or Withdrawal |
2.1; 1.7; 2.4; 2.8; 0.8; 0.9 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00615056). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.