Chemotherapy and Cetuximab in Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer
- Conditions
- Primary Peritoneal Cavity CancerColorectal Cancer
- Interventions
- Biological: cetuximabProcedure: adjuvant therapyProcedure: therapeutic conventional surgery
- Registration Number
- NCT00766142
- Lead Sponsor
- Institut BergoniƩ
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 18
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Chemotherapy + Cetuximab cetuximab Surgery + Chemotherapy + Cetuximab Chemotherapy + Cetuximab leucovorin calcium Surgery + Chemotherapy + Cetuximab Chemotherapy + Cetuximab adjuvant therapy Surgery + Chemotherapy + Cetuximab Chemotherapy + Cetuximab therapeutic conventional surgery Surgery + Chemotherapy + Cetuximab Chemotherapy + Cetuximab fluorouracil Surgery + Chemotherapy + Cetuximab Chemotherapy + Cetuximab oxaliplatin Surgery + Chemotherapy + Cetuximab
- Primary Outcome Measures
Name Time Method Median Progression-free Survival (PFS) Time Since surgery, up to 5 years 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.
- Secondary Outcome Measures
Name Time Method 30-day Mortality Rate from the date of surgery up to 30 days Rate of deaths observed within 30 days of surgery
Mean Number of Adverse Events Per Patient, Within 30 Days of Surgery from the date of surgery up to 30 days Overall Survival (OS) Time from surgery, up to five years. OS is the delay between surgery and death
Trial Locations
- Locations (1)
Institut Bergonie
š«š·Bordeaux, France