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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Colorectal Cancer; Peritoneal Cavity Cancer	Biological: cetuximab; Drug: fluorouracil; Drug: leucovorin calcium; Drug: oxaliplatin; Procedure: adjuvant therapy; Procedure: therapeutic conventional surgery	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	46 participants
Allocation:	Non-Randomized
Primary Purpose:	Treatment
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 2007
Estimated Primary Completion Date :	December 2009

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. Progression-free survival at 3 years

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

France
Institut Bergonie	Recruiting
Bordeaux, France, 33076
Contact: Serge Evrard 33-556-333-333

Sponsors and Collaborators

Institut Bergonié

Investigators

Study Chair:	Serge Evrard	Institut Bergonié

More Information

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ClinicalTrials.gov Identifier:	NCT00766142 History of Changes
Other Study ID Numbers:	CDR0000599511; IB-COCHISE-I; IB-2007-20; EUDRACT-2006-003900; MERCK-IB-COCHISE-I
First Posted:	October 3, 2008
Last Update Posted:	July 8, 2009
Last Verified:	July 2009

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the colon; recurrent colon cancer; stage IV colon cancer; adenocarcinoma of the rectum	recurrent rectal cancer; stage IV rectal cancer; peritoneal carcinomatosis

Additional relevant MeSH terms:

Colorectal Neoplasms; Carcinoma; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type	Oxaliplatin; Cetuximab; Fluorouracil; Levoleucovorin; Antineoplastic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antidotes; Protective Agents