Combination Chemotherapy and Cetuximab in Treating Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer
Recruitment status was Recruiting
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.
Peritoneal Cavity Cancer
Drug: leucovorin calcium
Procedure: adjuvant therapy
Procedure: therapeutic conventional surgery
|Study Design:||Allocation: Non-Randomized
Primary Purpose: Treatment
|Official Title:||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|
- Progression-free survival at 3 years [ Designated as safety issue: No ]
|Study Start Date:||May 2007|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
- 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 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.