Clinical Phase II Study Evaluating Systemic Chemotherapy in Combination With Cetuximab as Adjuvant Treatment in Patients With Completely Surgically Resected Peritoneal Carcinomatosis of Colorectal Origin
- Determine the efficacy of systemic chemotherapy and cetuximab, in terms of
progression-free survival at 3 years, in patients with completely resected peritoneal
carcinomatosis of colorectal origin.
- Determine the therapeutic strategy among patients who are or are not fit to receive
- Determine progression-free survival at 5 years and overall survival at 3 and 5 years in
- Determine the overall tolerability (mortality, morbidity) of this regimen, including
surgery, in these patients.
OUTLINE: This is a multicenter study.
Patients undergo complete resection of the peritoneal carcinomatosis. Beginning 4-8 weeks
after surgery, patients receive cetuximab IV over 2.5 hours. Patients also receive FOLFOX
chemotherapy comprising oxaliplatin IV and leucovorin calcium IV over 2 hours, and
fluorouracil IV continuously over 46 hours. Treatment repeats every 2 weeks for up to 12
After completion of study therapy, patients are followed every 4 months for 2 years and then
every 6 months for 3 years.
Allocation: Non-Randomized, Primary Purpose: Treatment
Progression-free survival at 3 years