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Sponsored by: |
Institut Bergonie |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00766142 |
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 |
Drug: cetuximab Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Procedure: adjuvant therapy Procedure: therapeutic conventional surgery |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized |
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 |
Estimated Enrollment: | 46 |
Study Start Date: | May 2007 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed colorectal adenocarcinoma meeting the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00766142 |
Health Authority: | Unspecified |
adenocarcinoma of the colon recurrent colon cancer stage IV colon cancer adenocarcinoma of the rectum |
recurrent rectal cancer stage IV rectal cancer peritoneal carcinomatosis |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Cetuximab Colonic Diseases Leucovorin Abdominal Neoplasms Intestinal Diseases Rectal Diseases Recurrence Intestinal Neoplasms Rectal neoplasm |
Carcinoma Calcium, Dietary Oxaliplatin Digestive System Diseases Fluorouracil Peritoneal Diseases Gastrointestinal Neoplasms Peritoneal Neoplasms Adenocarcinoma Rectal cancer Colorectal Neoplasms Neoplasms, Glandular and Epithelial |
Antimetabolites Neoplasms by Histologic Type Antimetabolites, Antineoplastic Vitamin B Complex Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances |
Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Vitamins Therapeutic Uses Micronutrients |