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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00766142
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : October 3, 2008
Last Update Posted : July 8, 2009
Information provided by:
National Cancer Institute (NCI)

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:



  • 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)
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

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab
U.S. FDA Resources

Primary Outcome Measures :
  1. Progression-free survival at 3 years

Information from the National Library of Medicine

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


  • 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


  • 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


  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00766142

Institut Bergonie Recruiting
Bordeaux, France, 33076
Contact: Serge Evrard    33-556-333-333      
Sponsors and Collaborators
Institut Bergonié
Study Chair: Serge Evrard Institut Bergonié Identifier: NCT00766142     History of Changes
Other Study ID Numbers: CDR0000599511
First Posted: October 3, 2008    Key Record Dates
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
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents