Folfox-B Study for Patients With Colorectal Liver Metastases
Summary
Objective: * To evaluate the efficacy of the use of the combination of oxaliplatin, 5-fluorouracil, leucovorin and bevacizumab (FOLFOX-B) in patients with unresectable colorectal liver metastases, with the objective to downstage hepatic disease and enable complete resection of residual disease. Primary Objective: * To evaluate the resection rate in patients with initially unresectable hepatic colorectal metastases downstaged with FOLFOX-B. Complete resection of all liver lesions is the goal. Secondary Objectives: * To evaluate the probability of complete response, partial response or stable disease. * To evaluate the proportion of patients who are resected, and the proportion of patients achieving an R0 resection (among those receiving surgery). * To correlate survival with downstaging and resection based on metastatic colorectal prognostic score. * To evaluate the disease-free survival and overall survival. * To evaluate the positron emission tomography response rate. * To explore correlations of clinical response with telomerase and hTERT expression.
Timeline
- Start
- 2005-11
- Primary completion
- 2009-06
- Completion
- 2009-06
Outcome
Outcome not reported
Stopped (Enrollment): “Slow accrual, study terminated.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |