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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Comparison of 5-FU/CF vs 5-FU/LEV vs 5-FU/CF/LEV as Adjuvant Therapy Following Potentially Curative Resection of Dukes' B and C Carcinoma of the Colon

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	under 71	NCI	NSABP-C-04 NCOG-NSABP-C-04, NCT00425152

Trial Description

Purpose:

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.

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.

Eligibility:

Eligibility criteria include the following:

• Younger then 71 years old
• No more than 6 weeks since surgery to remove the tumor
• No metastatic cancer
• No previous treatment other than surgery
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patient will be randomly assigned (have an equal chance of being placed) to one of three treatment groups.

Patients in group one will receive a 2-hour infusion of leucovorin and an infusion of fluorouracil once a week for 6 weeks. Treatment may repeat every 8 weeks for six courses.

Patients in group two will receive a 2-hour infusion of leucovorin and an infusion of fluorouracil once a week for 6 weeks. Treatment may repeat every 8 weeks for six courses. They will also receive levamisole by mouth three times a day on days 1-3. Treatment with levamisole may repeat every 2 weeks for 1 year.

Patients in group three will receive an infusion of fluorouracil on days 1-5. Beginning in week 5, they will receive an infusion of fluorouracil once a week for 1 year. Patients will also receive levamisole by mouth three times a day on days 1-3. Treatment with levamisole may repeat every 2 weeks for 1 year.

After finishing treatment, patients will be evaluated every 3 months for 1 year and every 6 months for 3 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

National Surgical Adjuvant Breast and Bowel Project

Norman Wolmark, MD, Protocol chair		Ph: 412-359-3336; 866-680-0004

Clinical Research Program - Northern California Cancer Center

Robert Carlson, MD, Protocol chair		Ph: 650-725-6457; 800-756-9000

Registry Information
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
Registered in ClinicalTrials.gov		NCT00425152
Date Submitted to PDQ		1990-12-31
Information Last Verified		2009-03-26

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