Study of Bevacizumab + mFOLFOX6 Versus Bevacizumab + FOLFIRI With Biomarker Stratification in Participants With Previously Untreated Metastatic Colorectal Cancer (mCRC)
Summary
This will be a randomized, open-label, multicenter, Phase II study with primary objectives to assess whether expression of select chemotherapy markers is associated with progression-free survival (PFS) in participants treated with bevacizumab plus leucovorin, 5-fluorouracil, and oxaliplatin (mFOLFOX6) or bevacizumab plus leucovorin, 5-fluorouracil, and irinotecan (FOLFIRI). The study population will consist of participants with first-line mCRC.
Timeline
- Start
- 2011-08
- Primary completion
- 2015-05
- Completion
- 2015-07
Outcome
Missed primary endpoint
registry Bevacizumab + mFOLFOX6 vs Bevacizumab + FOLFIRI; p = 0.0555; Hazard Ratio (HR) 0.79 (95% CI 0.61 to 1.01); Log Rank NCT01374425 ↗
registry Bevacizumab + mFOLFOX6 (ERCC-1 High) vs Bevacizumab + FOLFIRI (ERCC-1 High); p = 0.3944; Hazard Ratio (HR) 0.84 (95% CI 0.56 to 1.26); Log Rank NCT01374425 ↗
registry Bevacizumab + mFOLFOX6 (ERCC-1 Low) vs Bevacizumab + FOLFIRI (ERCC-1 Low); p = 0.0786; Hazard Ratio (HR) 0.76 (95% CI 0.55 to 1.03); Log Rank NCT01374425 ↗
registry Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 High) vs Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 Low); p = 0.9576; Hazard Ratio (HR) 0.99 (95% CI 0.77 to 1.28); Log Rank NCT01374425 ↗
registry Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A High) vs Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A Low); p = 0.1658; Hazard Ratio (HR) 1.19 (95% CI 0.93 to 1.53); Log Rank NCT01374425 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | 180 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Background | Bevacizumab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Background | Capecitabine | Small molecule | 850 mg/m2 | Oral |
| Background | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Background | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |