Trial Information

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.