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

Institut Bergonié

Status and phase

Terminated

Phase 2

Conditions

Primary Peritoneal Cavity Cancer

Colorectal Cancer

Treatments

Drug: oxaliplatin

Biological: cetuximab

Drug: leucovorin calcium

Procedure: therapeutic conventional surgery

Procedure: adjuvant therapy

Drug: fluorouracil

Study type

Interventional

Funder types

Other

Identifiers

NCT00766142

EUDRACT-2006-003900 (Registry Identifier)

MERCK-IB-COCHISE-I (Other Identifier)

IB-2007-20 (Other Identifier)

IB-COCHISE-I (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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