NCT00425152

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,151 (actual)
• Sponsor: NSABP Foundation Inc · Network
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	fluorouracil
DRUG	leucovorin calcium
DRUG	levamisole hydrochloride

Timeline

• Start date: 1989-07-01
• Primary completion: 1998-06-01
• Completion: 2004-04-01
• First posted: 2007-01-22
• Last updated: 2010-02-08