Colon Cancer Clinical Trial

Aspirin in Treating Patients With Colorectal Cancer That Has Been Surgically Removed

Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of aspirin may be an effective way to prevent the recurrence of polyps in colorectal cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of aspirin in treating patients who have stage I, stage II, or stage III colorectal cancer that has been surgically removed.

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Full Description

OBJECTIVES: I. Determine whether aspirin administered at a dose of 325 mg/day will decrease the number and size of new adenomas in patients with Dukes' A/B1/B2/C colorectal cancer who have undergone curative surgical resection. II. Assess whether this dose of aspirin will increase disease-free survival in these patients.

OUTLINE: Randomized, double-blind study. Arm I: Chemoprevention. Enteric-coated Aspirin, ASA, NSC-27223. Arm II: Control. Placebo, PLCB.

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Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically documented colorectal cancer that has been curatively resected, including: Dukes' A/B1 (T1-2, N0, M0) Dukes' B2/C (T3, N0, M0 and any T, N1, M0) disease-free more than 5 years post-resection Colonoscopy to the cecum (or small bowel anastomosis) with removal of all polyps required within 4 months of entry Preparation must be adequate to visualize mucosa and discern the presence of no further polyps No familial polyposis (more than 100 polyps at time of resection) No history of inflammatory bowel disease including ulcerative colitis or Crohn's disease

PATIENT CHARACTERISTICS: Age: 30 to under 75 Performance status: Physician's assessment of good general health required Life expectancy: At least 5 years Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No NYHA class III/IV status No history of angina No history of MI No history of stroke or TIAs No peripheral vascular disease No bleeding diathesis including hemorrhagic stroke No prophylactic aspirin for cardiovascular disease Other: No documented peptic ulcer disease within past 15 years No aspirin sensitivity including: Aspirin-induced asthma Bronchial hyper-reactivity Urticaria Angioedema No requirement for sodium warfarin or other anticoagulant No frequent (greater than 36 times/year) NSAID use within the past 5 years No recurrent arthritis or other musculoskeletal problems No narcotic or alcohol dependency (unless there has been at least a 6-month period of abstinence) No prior or concurrent malignancy within 5 years (including metastases) except nonmelanomatous skin cancer No pregnant or nursing women Effective contraception required of fertile women

PRIOR CONCURRENT THERAPY: No concurrent enrollment in a colon cancer treatment trial or other chemoprevention trial Biologic therapy: At least 6 months since immunosuppressive therapy (i.e., azathioprine, methotrexate, cyclosporine) Chemotherapy: Prior chemotherapy allowed for patients with Dukes' B2/C colorectal cancer No concurrent chemotherapy Endocrine therapy: Prior non-immunosuppressive steroid treatment allowed Radiotherapy: Prior radiotherapy allowed for patients with Dukes' B2/C colorectal cancer No concurrent radiotherapy Surgery: Curative resection required

Study is for people with:

Colon Cancer

Phase:

Phase 3

Estimated Enrollment:

635

Study ID:

NCT00002527

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 42 Locations for this study

See Locations Near You

CCOP - Scottsdale Oncology Program
Scottsdale Arizona, 85259, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco California, 94115, United States
CCOP - Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
University of Chicago Cancer Research Center
Chicago Illinois, 60637, United States
CCOP - Illinois Oncology Research Association
Peoria Illinois, 61602, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids Iowa, 52403, United States
CCOP - Iowa Oncology Research Association
Des Moines Iowa, 10309, United States
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States
Siouxland Hematology-Oncology
Sioux City Iowa, 51101, United States
CCOP - Ochsner
New Orleans Louisiana, 70121, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore Maryland, 21201, United States
Massachusetts General Hospital Cancer Center
Boston Massachusetts, 02114, United States
University of Massachusetts Memorial Medical Center
Worcester Massachusetts, 01655, United States
CCOP - Ann Arbor Regional
Ann Arbor Michigan, 48106, United States
University of Minnesota Cancer Center
Minneapolis Minnesota, 55455, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
CentraCare Clinic
Saint Cloud Minnesota, 56303, United States
Ellis Fischel Cancer Center - Columbia
Columbia Missouri, 65203, United States
Barnes-Jewish Hospital
Saint Louis Missouri, 63110, United States
CCOP - Missouri Valley Cancer Consortium
Omaha Nebraska, 68131, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas Nevada, 89106, United States
Norris Cotton Cancer Center
Lebanon New Hampshire, 03756, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
CCOP - North Shore University Hospital
Manhasset New York, 11030, United States
New York Presbyterian Hospital - Cornell Campus
New York New York, 10021, United States
State University of New York - Upstate Medical University
Syracuse New York, 13210, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill North Carolina, 27599, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem North Carolina, 27104, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem North Carolina, 27157, United States
Quain & Ramstad Clinic, P.C.
Bismarck North Dakota, 58501, United States
CCOP - Merit Care Hospital
Fargo North Dakota, 58122, United States
Altru Health Systems
Grand Forks North Dakota, 58201, United States
CCOP - Toledo Community Hospital Oncology Program
Toledo Ohio, 43623, United States
CCOP - Geisinger Clinical and Medical Center
Danville Pennsylvania, 17822, United States
Rhode Island Hospital
Providence Rhode Island, 02903, United States
Rapid City Regional Hospital
Rapid City South Dakota, 57709, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls South Dakota, 57105, United States
University of Tennessee, Memphis Cancer Center
Memphis Tennessee, 38163, United States
Vermont Cancer Center
Burlington Vermont, 05401, United States
MBCCOP - Massey Cancer Center
Richmond Virginia, 23298, United States
Saskatchewan Cancer Agency
Regina Saskatchewan, S4S 6, Canada

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 3

Estimated Enrollment:

635

Study ID:

NCT00002527

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

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