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Study 18 of 864 for search of: | United States, Hawaii |
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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) Eastern Cooperative Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00079274 |
RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining more than one chemotherapy drug with monoclonal antibody therapy and giving them after surgery may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective after surgery in treating colon cancer. (As of 6/1/2005, patients will no longer receive irinotecan on this study.)
PURPOSE: This randomized phase III trial is comparing three different combination chemotherapy regimens to see how well they work when given with or without cetuximab in treating patients who have undergone surgery for stage III colon cancer. (As of 6/1/2005, patients will no longer receive irinotecan on this study.)
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: cetuximab Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Drug: oxaliplatin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5-Fluorouracil (5-FU)/Leucovorin (CF) With or Without Cetuximab (C225) After Curative Resection for Patients With Stage III Colon Cancer |
Estimated Enrollment: | 2648 |
Study Start Date: | February 2004 |
Estimated Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours on days 1. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
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Drug: fluorouracil
Given IV
Drug: leucovorin calcium
Given IV
Drug: oxaliplatin
Given IV
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Arm II: Experimental
Patients receive irinotecan IV over 2 hours on day 1 and leucovorin calcium and fluorouracil as in arm I. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
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Drug: fluorouracil
Given IV
Drug: irinotecan hydrochloride
Given IV
Drug: leucovorin calcium
Given IV
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Arm III: Experimental
Patients receive the same treatment as in arm I for 6 courses followed by the same treatment as in arm II for 6 courses (total of 12 courses). Treatment continues in the absence of unacceptable toxicity or recurrent disease.
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Drug: fluorouracil
Given IV
Drug: irinotecan hydrochloride
Given IV
Drug: leucovorin calcium
Given IV
Drug: oxaliplatin
Given IV
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Arm IV: Experimental
Patients receive cetuximab IV over 1 hour on days 1 and 8 and oxaliplatin, leucovorin calcium, and fluorouracil as in arm I. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
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Drug: cetuximab
Given IV
Drug: fluorouracil
Given IV
Drug: leucovorin calcium
Given IV
Drug: oxaliplatin
Given IV
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Arm V: Experimental
Patients receive cetuximab as in arm IV and irinotecan, leucovorin calcium, and fluorouracil as in arm II. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
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Drug: cetuximab
Given IV
Drug: fluorouracil
Given IV
Drug: irinotecan hydrochloride
Given IV
Drug: leucovorin calcium
Given IV
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Arm VI: Experimental
Patients receive cetuximab as in arm IV and chemotherapy as in arm III.
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Drug: cetuximab
Given IV
Drug: fluorouracil
Given IV
Drug: irinotecan hydrochloride
Given IV
Drug: leucovorin calcium
Given IV
Drug: oxaliplatin
Given IV
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OBJECTIVES:
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to positive lymph node involvement (1-3 vs 4 or more), histology (high [poorly differentiated or undifferentiated] vs low [well to moderately differentiated]), and clinical T stage (T1 or T2 vs T3 vs T4). Patients are randomized to 1 of 6 treatment arms (as of 6/1/2005, patients are randomized to treatment arms I and IV only; arms II, III, V, and VI are closed to accrual).
NOTE: *Cetuximab is administered over 2 hours at a higher dose on day 1 of course 1 only.
Quality of life is assessed at baseline, before course 6, and at the end of therapy.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 3 years.
PROJECTED ACCRUAL: A total of 2,648 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years to 69 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the colon
No rectal cancer
Stage III tumor must have been completely resected within the past 56 days
At least 1 pathologically confirmed positive lymph node
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | Steven R. Alberts, MD | Mayo Clinic |
Investigator: | Albert M. Bernath, MD | CCOP - Geisinger Clinic and Medical Center |
Principal Investigator: | Frank Sinicrope, MD | Mayo Clinic |
Study Chair: | Gershon Y. Locker, MD, FACP | Evanston Northwestern Healthcare - Evanston Hospital |
Study ID Numbers: | CDR0000355132, NCCTG-N0147, ECOG-N0147 |
Study First Received: | March 8, 2004 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00079274 |
Health Authority: | Unspecified |
stage III colon cancer adenocarcinoma of the colon |
Digestive System Neoplasms Gastrointestinal Diseases Cetuximab Colonic Diseases Irinotecan Leucovorin Intestinal Diseases Rectal Diseases Camptothecin |
Intestinal Neoplasms Calcium, Dietary Oxaliplatin Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Adenocarcinoma Colonic Neoplasms Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Vitamin B Complex Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Vitamins Micronutrients Antineoplastic Agents, Phytogenic |