Fluorouracil and Leucovorin and/or Levamisole After Surgery In Treating Patients With Dukes' B Or Dukes' C Colon Cancer

National Surgical Adjuvant Breast and Bowel Project Foundation (NSABP)

Status and phase: Completed; Phase 3

Conditions: Colorectal Cancer

Treatments: Drug: levamisole hydrochloride; Drug: fluorouracil; Drug: leucovorin calcium

Study type: Interventional

Funder types: Other; NETWORK; NIH

Identifiers

NCT00425152

U10CA012027 (U.S. NIH Grant/Contract)

NCOG-NSABP-C-04

NSABP C-04

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2,151 patients

Sex: All

Ages: Under 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS: See General Eligibility Criteria

PATIENT CHARACTERISTICS: See General Eligibility Criteria