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

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

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.

Study Overview

• Status: Terminated
• Conditions: Colorectal Cancer; Primary Peritoneal Cavity Cancer
• Intervention / Treatment: Drug: fluorouracil; Drug: leucovorin calcium; Procedure: therapeutic conventional surgery; Procedure: adjuvant therapy; Drug: oxaliplatin; Biological: cetuximab

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • Institut Bergonié

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

DISEASE CHARACTERISTICS:

• Histologically confirmed colorectal adenocarcinoma meeting the following criteria:

  • Exclusively peritoneal carcinomatosis (no other metastases)
  • Resectable disease
• Primary tumor may be same in the same location as another synchronous carcinomatosis
• Patients with metastatic disease who have been in complete remission for more than 1 year are eligible regardless of prior chemotherapy

PATIENT CHARACTERISTICS:

• WHO performance status 0-2
• Life expectancy ≥ 12 weeks
• ANC ≥ 1.5 x 10^9/L
• Platelet count ≥ 100 x 10^9/L
• Hemoglobin ≥ 10 g/dL
• Bilirubin ≤ 1.25 times upper limit of normal (ULN)
• AST and ALT ≤ 3 times ULN
• Creatinine ≤ 1.25 times ULN
• Creatinine clearance ≥ 30 mL/min
• Not pregnant or nursing
• Fertile patients must use effective contraception
• No allergy, hypersensitivity, or other contraindication to leucovorin calcium, oxaliplatin, or fluorouracil
• No other noncancerous disease that would preclude study therapy
• Good nutritional status
• No sensitive peripheral neuropathy with functional impairment
• No hypoplasia or bone marrow failure
• No clinically significant cardiovascular disease within the past year (e.g., unstable angina or myocardial infarction)
• No other cancer within the past 5 years unless in complete remission with the exception of cervical carcinoma in situ or basal cell cancer
• No patients deprived of liberty or under supervision
• No psychological, social, familial, or geographical reasons prohibiting follow-up

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• At least 1 year since prior adjuvant chemotherapy, including prior therapy with oxaliplatin and/or cetuximab
• No prophylactic phenytoin (Dihydan®, Dilantin®)
• No prior yellow fever vaccine
• More than 1 month since participation in another study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chemotherapy + Cetuximab; Surgery + Chemotherapy + Cetuximab	Drug: fluorouracil; Drug: leucovorin calcium; Procedure: therapeutic conventional surgery; Procedure: adjuvant therapy; Drug: oxaliplatin; Biological: cetuximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Since surgery, up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day Mortality Rate	Rate of deaths observed within 30 days of surgery	from the date of surgery up to 30 days
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	OS is the delay between surgery and death	from surgery, up to five years.

Collaborators and Investigators

• Sponsor: Institut Bergonié
• Collaborators: Assistance Publique - Hôpitaux de Paris; Centre Leon Berard; Institut Cancerologie de l'Ouest; Hôpital Haut-Lévêque; Centre Alexis Vautrin, Nancy; Clinique Médicale de Francheville
• Investigators: Study Chair: Serge Evrard, Institut Bergonié

Publications and helpful links

General Publications

• Evrard S, Desolneux G, Bellera C, Esnaud T, Becouarn Y, Collet D, Chafai N, Marchal F, Cany L, Lermite E, Rivoire M, Mathoulin-Pelissier S. Systemic chemotherapy plus cetuximab after complete surgery in the treatment of isolated colorectal peritoneal carcinoma: COCHISE phase II clinical trial. BMC Res Notes. 2019 Jul 22;12(1):450. doi: 10.1186/s13104-019-4476-9.

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): September 17, 2013
• Study Completion (Actual): September 17, 2013

Study Registration Dates

• First Submitted: October 2, 2008
• First Submitted That Met QC Criteria: October 2, 2008
• First Posted (Estimated): October 3, 2008

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 28, 2025
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: adenocarcinoma of the rectum; stage IV rectal cancer; stage IV colon cancer; adenocarcinoma of the colon; recurrent colon cancer; recurrent rectal cancer; peritoneal carcinomatosis
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Peritoneal Diseases; Abdominal Neoplasms; Rectal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms; Peritoneal Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics; Drug Therapy; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Coordination Complexes; Pyrimidines; Leucovorin; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Uracil; Pyrimidinones; Combined Modality Therapy; Oxaliplatin; Cetuximab; Fluorouracil; Levoleucovorin; Chemotherapy, Adjuvant
• Other Study ID Numbers: IB-2007-20 (Institut Bergonié); IB-COCHISE-I (Other Identifier: Institut Bergonié); EUDRACT-2006-003900 (Registry Identifier: EUDRACT); MERCK-IB-COCHISE-I (Other Identifier: MERCK)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No