Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	no age specified	NCI	NCCTG-844652 EST-2284, MAYO-844652, SWOG-8591, INT-0035

Objectives

I.  Assess the effectiveness of levamisole alone and levamisole plus 
5-fluorouracil as surgical adjuvant regimens for resectable colon cancer by 
comparison with untreated controls.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologic proof of 
adenocarcinoma taking origin in the colon (ileo-cecal valve to reflection of 
pelvic peritoneum).  A potentially curative resection must have been performed 
with no gross or microscopic evidence of residual disease; margins of 
resection must be free of tumor involvement.  The resected specimen must show 
an indicator of poor prognosis, i.e., modified Dukes Stage B2 (serosal 
penetration), B3 (invasion of adjacent organs by direct extension), or C 
(involvement of regional lymph nodes).  At least 7 but no more than 30 days 
must have elapsed since surgery, and there may be no active complications.  
Patients must be able to reliably tolerate oral medications.  Prior therapy 
with 5-fluorouracil or levamisole and respective WBC and platelet counts less 
than 4,000 and 130,000 exclude.  There may be no evidence of distant 
metastasis and no regional metastasis that cannot be resected en bloc with the 
primary lesion.  There may have been no other malignant tumors within 5 years 
of entry except for superficial squamous or basal cell carcinoma of the skin 
or carcinoma in situ of the cervix.  Per NCCTG Addendum 2, January 1986, 
patients with more than one simultaneously diagnosed carcinoma primary to the 
colon are eligible; they will be stratified according to the most advanced 
stage lesion.

Expected Enrollment

It is hoped that approximately 400 patients with Dukes Stage B (equally 
randomized between Arms I and II) and 600 patients with Dukes Stage C (equally 
randomized between Arms I, II, and III) will be accrued over 24 and 18 months, 
respectively.  Per Addendum 4, March 1987, 900 Stage C patients will be 
randomized (300 on each arm), with completion of patient entry anticipated by 
October 1987.

Outline

Randomized study.  Patients are randomized for treatment following resection 
of the large bowel.  Those with Dukes Stages B2/B3 are randomized to Arms I 
and II, and those with Dukes Stage C are randomized to Arms I, II, and III.
Arm I:  No adjuvant therapy.
Arm II:  Adjuvant Immunotherapy plus Chemotherapy.  Levamisole, LEV, 
NSC-177023; plus 5-Fluorouracil, 5-FU, NSC-19893.
Arm III:  Single-agent Adjuvant Immunotherapy.  LEV.

Goldberg RM, Fleming TR, Tangen CM, et al.: Surgery for recurrent colon cancer: strategies for identifying resectable recurrence and success rates after resection. Eastern Cooperative Oncology Group, the North Central Cancer Treatment Group, and the Southwest Oncology Group. Ann Intern Med 129 (1): 27-35, 1998.[PUBMED Abstract]

Goldberg RM, Moertel CG, Fleming TR, et al.: Salvage surgery (SS) for recurrent colon cancer (CC) in patients (pts) entered on INT 0035: an evaluation of levamisole alone or levamisole + 5-fluorouracil as surgical adjuvant treatment for resectable colon cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 16: A-992, 280a, 1997.

Donohue JH, Williams S, Cha S, et al.: Perioperative blood transfusions do not affect disease recurrence of patients undergoing curative resection of colorectal carcinoma: a Mayo/North Central Cancer Treatment Group study. J Clin Oncol 13 (7): 1671-8, 1995.[PUBMED Abstract]

Moertel CG, Fleming TR, Macdonald JS, et al.: Fluorouracil plus levamisole as effective adjuvant therapy after resection of stage III colon carcinoma: a final report. Ann Intern Med 122 (5): 321-6, 1995.[PUBMED Abstract]

Moertel CG, Fleming TR, Macdonald JS, et al.: Intergroup study of fluorouracil plus levamisole as adjuvant therapy for stage II/Dukes' B2 colon cancer. J Clin Oncol 13 (12): 2936-43, 1995.[PUBMED Abstract]

Moertel CG, Fleming TR, Macdonald JS, et al.: Hepatic toxicity associated with fluorouracil plus levamisole adjuvant therapy. J Clin Oncol 11 (12): 2386-90, 1993.[PUBMED Abstract]

Moertel CG, Fleming TR, Macdonald JS, et al.: An evaluation of the carcinoembryonic antigen (CEA) test for monitoring patients with resected colon cancer. JAMA 270 (8): 943-7, 1993.[PUBMED Abstract]

Augenlicht L, Corner G, Heerdt B, et al.: C-myc amplification in human colonic tumors: an Eastern Cooperative Oncology Group study. [Abstract] Proceedings of the American Society of Clinical Oncology 11: A-249, 1992.

Moertel CG, Fleming TR, Macdonald JS, et al.: Levamisole and fluorouracil for adjuvant therapy of resected colon carcinoma. N Engl J Med 322 (6): 352-8, 1990.[PUBMED Abstract]

Garrity MM, Burgart LJ, Mahoney MR, et al.: Prognostic value of proliferation, apoptosis, defective DNA mismatch repair, and p53 overexpression in patients with resected Dukes' B2 or C colon cancer: a North Central Cancer Treatment Group Study. J Clin Oncol 22 (9): 1572-82, 2004.[PUBMED Abstract]

Benson AB, Catalano P, Rao S, et al.: Thymidylate synthase expression as a predictor for response to 5-fluorouracil-based therapy and survival for patients with resected colon or advanced colorectal cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 16: A917, 158a, 1997.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

John Laurie, MD, MB, ChB, Protocol chair(Contact information may not be current)		Ph: 701-780-6389

Mayo Clinic Cancer Center

Charles G. Moertel, MD, Protocol chair(Contact information may not be current)		Ph: 507-284-2511

Southwest Oncology Group

John MacDonald, MD, Protocol chair		Ph: 212-604-6011; 888-442-2623

Eastern Cooperative Oncology Group

Daniel Haller, MD, Protocol chair		Ph: 215-662-6318

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