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

NCT ID: NCT00766142

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-01
• Study Completion Date: 2013-09-17

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.

Conditions

Colorectal Cancer; Primary Peritoneal Cavity Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chemotherapy + Cetuximab

Surgery + Chemotherapy + Cetuximab

Group Type: EXPERIMENTAL

cetuximab

Intervention Type: BIOLOGICAL

fluorouracil

Intervention Type: DRUG

leucovorin calcium

Intervention Type: DRUG

oxaliplatin

Intervention Type: DRUG

adjuvant therapy

Intervention Type: PROCEDURE

therapeutic conventional surgery

Intervention Type: PROCEDURE

Interventions

cetuximab

Intervention Type: BIOLOGICAL

fluorouracil

Intervention Type: DRUG

leucovorin calcium

Intervention Type: DRUG

oxaliplatin

Intervention Type: DRUG

adjuvant therapy

Intervention Type: PROCEDURE

therapeutic conventional surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: collaborator

Centre Alexis Vautrin, Nancy

OTHER

Sponsor Role: collaborator

Centre Leon Berard

OTHER

Sponsor Role: collaborator

Institut Cancerologie de l'Ouest

OTHER

Sponsor Role: collaborator

Hôpital Haut-Lévêque

OTHER

Sponsor Role: collaborator

Clinique Médicale de Francheville

OTHER

Sponsor Role: collaborator

Institut Bergonié

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Serge Evrard

Role: STUDY_CHAIR

Institut Bergonié

Locations

Institut Bergonie

Bordeaux, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 31331370 (View on PubMed)

Other Identifiers

IB-COCHISE-I

Identifier Type: OTHER

Identifier Source: secondary_id

EUDRACT-2006-003900

Identifier Type: REGISTRY

Identifier Source: secondary_id

MERCK-IB-COCHISE-I

Identifier Type: OTHER

Identifier Source: secondary_id

IB-2007-20

Identifier Type: -

Identifier Source: org_study_id