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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

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

History of Changes

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:

MedlinePlus related topics: Colorectal Cancer

Drug Information available for: Cetuximab

U.S. FDA Resources

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

Primary Outcome Measures:

Progression-free survival at 3 years


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 (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

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


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

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

ClinicalTrials.gov processed this record on September 21, 2017

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