Frontline Chemotherapy "Reinforced" for Cancers of the Colon and Rectum With Potentially Resectable Hepatic and/or Pulmonary Metastases: Association of FOLFIRI and ERBITUX
OBJECTIVES:
Primary
- 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.
Secondary
- 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
metastases.
Interventional
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor response rate
From baseline to end of treatment
No
Jean Marc Phelip, MD, PhD
Study Chair
University Hospital, Grenoble
France: Agence Nationale de Sécurité du Médicament et des produits de santé
CDR0000574153
NCT00557102
September 2007
December 2010
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