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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00766142
First received: October 2, 2008
Last updated: July 7, 2009
Last verified: July 2009
  Purpose

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 Intervention Phase
Colorectal Cancer
Peritoneal Cavity Cancer
Biological: cetuximab
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Procedure: adjuvant therapy
Procedure: therapeutic conventional surgery
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival at 3 years [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: May 2007
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766142

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

Additional Information:
No publications provided

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
Study First Received: October 2, 2008
Last Updated: July 7, 2009
Health Authority: Unspecified

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
Peritoneal Neoplasms
Carcinoma
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Abdominal Neoplasms
Peritoneal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fluorouracil
Oxaliplatin
Cetuximab
Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on August 28, 2014