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

Sponsor:	National Surgical Adjuvant Breast and Bowel Project (NSABP)
Collaborators:	National Cancer Institute (NCI) Northern California Cancer Center
Information provided by:	National Surgical Adjuvant Breast and Bowel Project (NSABP)
ClinicalTrials.gov Identifier:	NCT00425152

Purpose

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.

Condition	Intervention	Phase
Colorectal Cancer	Drug: fluorouracil Drug: leucovorin calcium Drug: levamisole hydrochloride	Phase III

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Fluorouracil Leucovorin Levamisole Levamisole hydrochloride Citrovorum factor Leucovorin Calcium Folinic acid calcium salt pentahydrate

U.S. FDA Resources

Further study details as provided by National Surgical Adjuvant Breast and Bowel Project (NSABP):

Enrollment:	2151
Study Start Date:	July 1989
Study Completion Date:	April 2004
Primary Completion Date:	June 1998 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	up to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS: See General Eligibility Criteria

PATIENT CHARACTERISTICS: See General Eligibility Criteria

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425152

Sponsors and Collaborators

National Surgical Adjuvant Breast and Bowel Project (NSABP)

National Cancer Institute (NCI)

Northern California Cancer Center

Investigators

Study Chair:	Norman Wolmark, MD	Allegheny Cancer Center at Allegheny General Hospital
Study Chair:	Robert W. Carlson, MD	Stanford University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Wolmark N, Rockette H, Mamounas E, Jones J, Wieand S, Wickerham DL, Bear HD, Atkins JN, Dimitrov NV, Glass AG, Fisher ER, Fisher B. Clinical trial to assess the relative efficacy of fluorouracil and leucovorin, fluorouracil and levamisole, and fluorouracil, leucovorin, and levamisole in patients with Dukes' B and C carcinoma of the colon: results from National Surgical Adjuvant Breast and Bowel Project C-04. J Clin Oncol. 1999 Nov;17(11):3553-9.

Wolmark N, Rockette H, Mamounas EP, et al.: The relative efficacy of 5-FU + leucovorin (FU-LV), 5-FU + levamisole (FU-LEV), and 5-FU + leucovorin + levamisole (FU-LV-LEV) in patients with Dukes' B and C carcinoma of the colon: first report of NSABP C-04. [Abstract] Proceedings of the American Society of Clinical Oncology 15: A460, 205a, 1996.

Wilkinson NW, Yothers G, Lopa SH, et al.: Long-term survival results of surgery alone compared with surgery plus 5-fluorouracil and leucovorin for stage II and stage III colon cancer: pooled analysis of NSABP adjuvant trials C-01 through C-05. [Abstract] American Society of Clinical Oncology 2009 Gastrointestinal Cancers Symposium, 15-17 January 2009, San Francisco, CA. A-442, 2009.

Kim GP, Colangelo LH, Wieand HS, Paik S, Kirsch IR, Wolmark N, Allegra CJ; National Cancer Institute. Prognostic and predictive roles of high-degree microsatellite instability in colon cancer: a National Cancer Institute-National Surgical Adjuvant Breast and Bowel Project Collaborative Study. J Clin Oncol. 2007 Mar 1;25(7):767-72. Epub 2007 Jan 16.

Dignam JJ, Polite BN, Yothers G, Raich P, Colangelo L, O'Connell MJ, Wolmark N. Body mass index and outcomes in patients who receive adjuvant chemotherapy for colon cancer. J Natl Cancer Inst. 2006 Nov 15;98(22):1647-54.

Wang SJ, Zamboni BA, Wieand HS, et al.: Conditional survival for patients with colon cancer: an analysis of National Surgical Adjuvant Breast and Bowel Project (NSABP) trials C-03 through C-06. [Abstract] J Clin Oncol 24 (Suppl 18): A-6005, 302s, 2006.

Kim GP, Colangelo L, Wieand H, et al.: Prognostic and predictive roles of high-degree microsatellite instability (MSI-H) in colon cancer: National Cancer Institute (NCI)-National Surgical Adjuvant Bowel Project (NSABP) collaborative study. [Abstract] American Society of Clinical Oncology 2005 Gastrointestinal Cancers Symposium, 27-29 January 2005, Miami, Florida. A-227, 2005.

Allegra CJ, Paik S, Colangelo LH, Parr AL, Kirsch I, Kim G, Klein P, Johnston PG, Wolmark N, Wieand HS. Prognostic value of thymidylate synthase, Ki-67, and p53 in patients with Dukes' B and C colon cancer: a National Cancer Institute-National Surgical Adjuvant Breast and Bowel Project collaborative study. J Clin Oncol. 2003 Jan 15;21(2):241-50.

Wolmark N, Colangelo L, Wieand S. National Surgical Adjuvant Breast and Bowel Project trials in colon cancer. Semin Oncol. 2001 Feb;28(1 Suppl 1):9-13.

Dignam JJ, Colangelo L, Tian W, Jones J, Smith R, Wickerham DL, Wolmark N. Outcomes among African-Americans and Caucasians in colon cancer adjuvant therapy trials: findings from the National Surgical Adjuvant Breast and Bowel Project. J Natl Cancer Inst. 1999 Nov 17;91(22):1933-40.

Mamounas E, Wieand S, Wolmark N, Bear HD, Atkins JN, Song K, Jones J, Rockette H. Comparative efficacy of adjuvant chemotherapy in patients with Dukes' B versus Dukes' C colon cancer: results from four National Surgical Adjuvant Breast and Bowel Project adjuvant studies (C-01, C-02, C-03, and C-04) J Clin Oncol. 1999 May;17(5):1349-55.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Yothers G, Sargent DJ, Wolmark N, Goldberg RM, O'Connell MJ, Benedetti JK, Saltz LB, Dignam JJ, Blackstock AW; ACCENT Collaborative Group. Outcomes among black patients with stage II and III colon cancer receiving chemotherapy: an analysis of ACCENT adjuvant trials. J Natl Cancer Inst. 2011 Oct 19;103(20):1498-506. Epub 2011 Oct 12.

Responsible Party:	Norman Wolmark, MD, NSABP Foundation, Inc.
ClinicalTrials.gov Identifier:	NCT00425152 History of Changes
Other Study ID Numbers:	NSABP C-04, U10CA012027, NCOG-NSABP-C-04
Study First Received:	January 18, 2007
Last Updated:	February 5, 2010
Health Authority:	United States: Federal Government

Keywords provided by National Surgical Adjuvant Breast and Bowel Project (NSABP):

stage II colon cancer
stage III colon cancer

Additional relevant MeSH terms:

Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
Levamisole
Leucovorin

Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes

ClinicalTrials.gov processed this record on February 12, 2012