Frontline Chemotherapy "Reinforced" for Cancers of the Colon and Rectum With Potentially Resectable Hepatic and/or Pulmonary Metastases: Association of FOLFIRI and ERBITUX
- Determine the tumor response rate in patients with colorectal cancer and hepatic and/or
pulmonary metastases treated with cetuximab and FOLFIRI chemotherapy comprising
irinotecan hydrochloride, leucovorin calcium, and fluorouracil as first-line therapy.
- Determine the rate of resectability in patients treated with this regimen.
- Determine the overall and disease-free survival of patients treated with this regimen.
- Determine the tolerability of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 60-120 minutes on days 1 and 8. Patients also receive
FOLFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes and leucovorin
calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 48 hours on days 1
and 2. Patients with 7/6 or 7/7 genotypes also receive filgrastim (G-CSF) as primary
prophylaxis (patients with 6/6 genotypes receive G-CSF as secondary prophylaxis). Treatment
repeats every 2 weeks for up to 8 courses in the absence of disease progression or
unacceptable toxicity. Within 6 weeks after the completion of cetuximab and FOLFIRI
chemotherapy, patients with responding disease undergo surgical resection of visceral
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor response rate
From baseline to end of treatment
Jean Marc Phelip, MD, PhD
University Hospital, Grenoble
France: Agence Nationale de Sécurité du Médicament et des produits de santé