Fluorouracil and Leucovorin and/or Levamisole After Surgery In Treating Patients With Dukes' B Or Dukes' C Colon Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colorectal Cancer
Intervention: fluorouracil (Drug); leucovorin calcium (Drug); levamisole hydrochloride (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: National Surgical Adjuvant Breast and Bowel Project (NSABP) Official(s) and/or principal investigator(s):
Norman Wolmark, MD, Study Chair, Affiliation: Allegheny Cancer Center at Allegheny General Hospital
Robert W. Carlson, MD, Study Chair, Affiliation: Stanford University
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.
Clinical Details
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
Study design: Treatment
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
Minimum age: N/A.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS: See General Eligibility Criteria
PATIENT CHARACTERISTICS: See General Eligibility Criteria
Locations and Contacts
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Related publications: 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.
Last updated: May 23, 2008
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