RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving more than one drug (combination chemotherapy) together with cetuximab may kill more tumor cells. PURPOSE: This phase II trial is studying how well chemotherapy given together with cetuximab works in treating patients undergoing surgery to remove peritoneal carcinomatosis from colorectal cancer.
OBJECTIVES: Primary * 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. Secondary * Determine the therapeutic strategy among patients who are or are not fit to receive chemotherapy. * Determine progression-free survival at 5 years and overall survival at 3 and 5 years in these patients. * 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 courses. After completion of study therapy, patients are followed every 4 months for 2 years and then every 6 months for 3 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Institut Bergonie
Bordeaux, France
Median Progression-free Survival (PFS) Time
Progression-free survival time is defined as the time from the date of surgery to the date of progression (as per RECIST v1.1) or death of any cause, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: Since surgery, up to 5 years
30-day Mortality Rate
Rate of deaths observed within 30 days of surgery
Time frame: from the date of surgery up to 30 days
Mean Number of Adverse Events Per Patient, Within 30 Days of Surgery
Time frame: from the date of surgery up to 30 days
Overall Survival (OS) Time
OS is the delay between surgery and death
Time frame: from surgery, up to five years.
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