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Sponsors and Collaborators: |
National Surgical Adjuvant Breast and Bowel Project (NSABP) National Cancer Institute (NCI) Clinical Research Program - Northern California Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00425152 |
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Leucovorin may help fluorouracil kill more tumor cells. Biological therapies, such as levamisole, may interfere with the growth of tumor cells and slow the growth of solid tumors. It is not yet known whether fluorouracil is more effective when given together with leucovorin and/or levamisole after surgery in treating colon cancer.
PURPOSE: This randomized phase III trial is studying giving fluorouracil together with leucovorin to see how well it works compared with giving fluorouracil together with levamisole, or giving fluorouracil together with leucovorin and levamisole after surgery in treating patients with Dukes' B or Dukes' C colon cancer.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: fluorouracil Drug: leucovorin calcium Drug: levamisole hydrochloride |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Clinical Trial to Assess the Relative Efficacy of 5-FU + Leucovorin, 5-FU + Levamisole, and 5-FU + Leucovorin + Levamisole in Patients With Dukes' B and C Carcinoma of the Colon |
OBJECTIVES: I. Compare, in a Phase III setting, disease-free survival and overall survival of patients who have undergone potentially curative resection of Dukes' B or C carcinoma of the colon randomly assigned to adjuvant therapy with 5-fluorouracil/leucovorin vs. 5-fluorouracil/levamisole vs. 5-fluorouracil/leucovorin/levamisole.
OUTLINE: Randomized study. Arm I: Single-agent Chemotherapy with Drug Modulation. 5-Fluorouracil, 5-FU, NSC-19893; with Leucovorin calcium, Citrovorum Factor, CF, NSC-3590. Arm II: Single-agent Chemotherapy with Drug Modulation plus Biological Response Modifier Therapy. 5-FU; with CF; plus Levamisole, LEV, NSC-177023. Arm III: Single-agent Chemotherapy plus Biological Response Modifier Therapy. 5-FU; plus LEV.
PROJECTED ACCRUAL: 1,800 evaluable patients will be accrued over about 3 years; an additional 2 years will be required before final analysis.
Ages Eligible for Study: | up to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: See General Eligibility Criteria
PATIENT CHARACTERISTICS: See General Eligibility Criteria
Study Chair: | Norman Wolmark, MD | Allegheny Cancer Center at Allegheny General Hospital |
Study Chair: | Robert W. Carlson, MD | Stanford University |
Study ID Numbers: | CDR0000075754, NSABP-C-04, NCOG-NSABP-C-04 |
Study First Received: | January 18, 2007 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00425152 |
Health Authority: | United States: Federal Government |
stage II colon cancer stage III colon cancer |
Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Leucovorin Intestinal Diseases Rectal Diseases Intestinal Neoplasms Carcinoma |
Calcium, Dietary Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Levamisole Colonic Neoplasms Colorectal Neoplasms |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Vitamin B Complex Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Adjuvants, Immunologic Anthelmintics |
Immunosuppressive Agents Pharmacologic Actions Antiparasitic Agents Neoplasms Neoplasms by Site Therapeutic Uses Vitamins Micronutrients Antirheumatic Agents Antinematodal Agents |