NCT00766142

Chemotherapy and Cetuximab in Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Institut Bergonié · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Colorectal Cancer
• Primary Peritoneal Cavity Cancer

Interventions

Type	Name	Description
BIOLOGICAL	cetuximab
DRUG	fluorouracil
DRUG	leucovorin calcium
DRUG	oxaliplatin
PROCEDURE	adjuvant therapy
PROCEDURE	therapeutic conventional surgery

Timeline

• Start date: 2007-05-01
• Primary completion: 2013-09-17
• Completion: 2013-09-17
• First posted: 2008-10-03
• Last updated: 2025-08-29
• Results posted: 2021-01-26

Locations

1 site across 1 country: France