Chemotherapy and Cetuximab in Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer (COCHISE)
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|ClinicalTrials.gov Identifier: NCT00766142|
Recruitment Status : Terminated (In 2008, new data highlighted that Cetuximab had no efficacy in case of KRAS mutation. As such, eligibility criteria were revised and limited to KRAS wild-type. Inclusions were thus slown down considerably, and the trial was stopped.)
First Posted : October 3, 2008
Results First Posted : January 26, 2021
Last Update Posted : January 26, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Primary Peritoneal Cavity Cancer||Biological: cetuximab Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Procedure: adjuvant therapy Procedure: therapeutic conventional surgery||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Combination Chemotherapy and Cetuximab in Treating Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 1, 2007|
|Actual Primary Completion Date :||September 17, 2013|
|Actual Study Completion Date :||September 17, 2013|
Experimental: Chemotherapy + Cetuximab
Surgery + Chemotherapy + Cetuximab
Drug: leucovorin calcium
Procedure: adjuvant therapy
Procedure: therapeutic conventional surgery
- Median Progression-free Survival (PFS) Time [ Time Frame: 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.
- 30-day Mortality Rate [ Time Frame: 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 [ Time Frame: from the date of surgery up to 30 days ]
- Overall Survival (OS) Time [ Time Frame: from surgery, up to five years. ]OS is the delay between surgery and death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00766142
|Bordeaux, France, 33076|
|Study Chair:||Serge Evrard||Institut Bergonié|