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Home > "C" Clinical Trials Conditions > Comparison of Sulindac, Aspirin, and Ursodiol in Preventing Colorectal Cancer  Comparison of Sulindac, Aspirin, and Ursodiol in Preventing Colorectal Cancer
Comparison of Sulindac, Aspirin, and Ursodiol in Preventing Colorectal Cancer
For Condition: stage 4 colon cancer,stage 2 colon cancer,stage 3 colon cancer,stage 1 colon cancer,Colorectal Cancer
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. It is not yet known whether sulindac, aspirin, or ursodiol is more effective in preventing colorectal cancer. PURPOSE: Randomizedphase II trial to compare the effectiveness of sulindac, aspirin, and ursodiol in preventing colorectal cancer.
Details: OBJECTIVES: - Determine the percentage change in colorectal aberrant crypt foci (ACF) in patients with a history of colorectal cancer or at high risk for colorectal cancer when treated with sulindac vs aspirin vs ursodiol. - Determine the safety and efficacy of these drugs, in terms of ability to cause regression of existing colorectal ACF and prevent new ACF development, in these patients. OUTLINE: This is a partially blinded, randomized, placebo-controlled study. Patients are stratified according to colorectal neoplasia (adenoma vs carcinoma). Patients are randomized to 1 of 4 treatment arms. - Arm I: Patients receive oral sulindac twice daily. - Arm II: Patients receive oral aspirin once daily. - Arm III: Patients receive oral ursodiol three times daily. - Arm IV: Patients receive oral sulindac placebo twice daily. In all arms, treatment continues for 12 months in the absence of disease progression or unacceptable toxicity. Patients undergo a colonoscopy at baseline and at the end of treatment. Patients are followed at 2 months after the end of treatment. PROJECTED ACCRUAL: A total of 172 patients (43 per treatment arm) with a history of colorectal cancer or adenomas will be accrued for this study. A total of 20 additional patients with no elevated risk of colorectal neoplasia will be accrued, but not randomized, for this study.
Eligibility:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 40 Years/80 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Presence of at least 5 colorectal aberrant crypt foci - Meets 1 of the following criteria: - Recent or current history of colorectal cancer* defined by 1 of the following: - Dukes' A/B1 carcinoma within the past 5 years - Any stage of colorectal cancer if at least 5 years after surgical resection NOTE: *No rectal cancer except for transanal excision without radiotherapy - Recent or current history of colorectal adenoma(s) defined by 1 of the following: - One adenomatous polyp at least 1 cm - Two or more adenomatous polyps of any size - One adenomatous polyp of any size and a documented history of prior adenomatous polyps - No elevated risk of colorectal cancer or adenoma - No known familial adenomatous polyposis - No hereditary nonpolyposis colon cancer - No inflammatory bowel disease PATIENT CHARACTERISTICS: Age - 40 to 80 Performance status - Not specified Life expectancy - Not specified Hematopoietic - WBC greater than 3,000/mm^3 - Platelet count greater than 100,000/mm^3 - Hemoglobin greater than 10.0 g/dL - No bleeding diathesis Hepatic - Bilirubin no greater than 1.5 mg/dL - AST and ALT less than 2 times upper limit of normal - No unexplained elevation of transaminases - No acute liver disease Renal - No history of renal stones Pulmonary - No asthma Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Able to participate in scheduled follow-up tests - No history of gastroduodenal ulcers by endoscopy - No history of hypersensitivity to cyclo-oxygenase-2 inhibitors, sulfonamides, NSAIDs, salicylates, or ursodiol - No hypersensitivity to sulindac products - No significant medical or psychiatric problem that would preclude study participation - No other invasive carcinoma within the past 5 years except Dukes' A/B1 carcinoma or any stage of colorectal cancer that is at least 5 years post-surgical resection - No "unacceptable clinical risk" to proceed including: - New diagnosis of carcinoma - Suspicion of need for colectomy PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - More than 6 months since prior chemotherapy - Topical chemotherapy may be allowed on a case-by-case basis Endocrine therapy - At least 30 days since prior nasal steroids - No concurrent nasal steroids (mometasone allowed) - No concurrent oral corticosteroids Radiotherapy - No prior radiotherapy to the pelvis or rectum Surgery - See Disease Characteristics - No prior colectomy Other - More than 3 months since prior investigational agents - At least 3 months since prior nonsteroidal anti-inflammatory drugs (NSAIDs) (including aspirin) - Concurrent acetaminophen allowed - No concurrent aspirin (including as a cardioprotectant) - No concurrent NSAIDs (e.g., ibuprofen or naproxen)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertBresalier, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Robert Bresalier 713-745-4340
Additional Information:
Study ID Numbers: CDR0000304433; MDA-ID-01454
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00062023
Other Stage 1 Colon Cancer Studies:
1. Comparison of Sulindac, Aspirin, and Ursodiol in Preventing Colorectal Cancer
2. Laparoscopic-Assisted Surgery Compared With Open Surgery in Treating Patients With Colon Cancer
3. Diagnostic Procedure for Identifying Patients With Metastatic Colorectal Cancer
4. Lymph Node Mapping and Sentinel Lymph Node Biopsy in Patients With Stage I, Stage II, or Stage III Colorectal Cancer
5. Genetic Study of Familial Factors in Patients With Colon Cancer
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Comparison of Sulindac, Aspirin, and Ursodiol in Preventing Colorectal Cancer
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