Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborators:
Northern California Cancer Center
Information provided by:
NSABP Foundation Inc
ClinicalTrials.gov Identifier:
NCT00425152
First received: January 18, 2007
Last updated: February 5, 2010
Last verified: February 2010

January 18, 2007
February 5, 2010
July 1989
June 1998   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00425152 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: fluorouracil
  • Drug: leucovorin calcium
  • Drug: levamisole hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2151
April 2004
June 1998   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS: See General Eligibility Criteria

PATIENT CHARACTERISTICS: See General Eligibility Criteria

Both
up to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00425152
NSABP C-04, U10CA012027, NCOG-NSABP-C-04
Yes
Norman Wolmark, MD, NSABP Foundation, Inc.
NSABP Foundation Inc
  • National Cancer Institute (NCI)
  • Northern California Cancer Center
Study Chair: Norman Wolmark, MD Allegheny Cancer Center at Allegheny General Hospital
Study Chair: Robert W. Carlson, MD Stanford University
NSABP Foundation Inc
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP