Randomized Phase II Trial Evaluating the Feasibility and Tolerance of the Combination of FOLFOX With Cetuximab and the Combination of FOLFOX With Cetuximab and Bevacizumab as Perioperative Treatment in Patients With Resectable Liver Metastases From Colorectal Cancer
- Compare the safety and activity of neoadjuvant and adjuvant cetuximab, leucovorin
calcium, oxaliplatin, and fluorouracil with vs without bevacizumab in patients with
resectable liver metastases secondary to colorectal cancer.
OUTLINE: This is an open-label, randomized, multicenter study. Patient are stratified
according to participating center and planned liver resection (major [≥ 3 segments] vs minor
[< 3 segments]). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive leucovorin calcium IV over 2 hours and oxaliplatin IV over 2
hours on day 1 and fluorouracil IV over 46 hours (FOLFOX) beginning on day 1. Patients
also receive cetuximab IV over 1-2 hours on days 1 and 8. Treatment repeats every 14
days for 6 courses in the absence of disease progression or unacceptable toxicity.
Between 3-5 weeks after completion of FOLFOX and cetuximab, patients undergo liver
resection. Beginning between 4-8 weeks after surgery, patients receive another 6 courses of
FOLFOX and cetuximab as in neoadjuvant therapy.
- Arm II: Patients receive FOLFOX and cetuximab as in arm I and bevacizumab IV over 30-90
minutes on day 1. Treatment repeats every 14 days for 6 courses* in the absence of
disease progression or unacceptable toxicity.
NOTE: *Patients do not receive bevacizumab during course 6
Between 3-5 weeks after completion of FOLFOX, cetuximab, and bevacizumab, patients undergo
liver resection. Beginning between 4-8 weeks after surgery, patients receive another 6
courses of FOLFOX, cetuximab, and bevacizumab as in neoadjuvant therapy.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for at least 3 years.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Response rate (preoperative response rate)
Bernard Nordlinger, MD
Hopital Ambroise Pare
United States: Federal Government