Exisulind in Preventing Polyps in Patients With Familial Adenomatous Polyposis

Study Overview
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Brief Summary
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RATIONALE: Exisulind may be effective in preventing the development and growth of polyps in patients who have familial adenomatous polyposis. PURPOSE: Randomized phase II/III trial to determine the effectiveness of exisulind in preventing the development and growth of polyps in patients who have familial adenomatous polyposis.

Detailed Description
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OBJECTIVES: Determine the ability of exisulind to inhibit growth and development of duodenal adenomas in patients with familial adenomatous polyposis. Determine the effect on apoptosis in polyp vs mucosal tissue in these patients when treated with this drug. OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral exisulind 4 times daily. Arm II: Patients receive oral placebo 4 times daily. Treatment continues for 1 year. PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.

Official Title
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Chemoprevention of Duodenal Polyps in Familial Adenomatous Polyposis

Conditions
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Colorectal Cancer, Small Intestine Cancer

Intervention / Treatment
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* Drug: exisulind


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: One of the following diagnosis: Diagnosis of familial adenomatous polyposis Prior total or subtotal colectomy Attenuated adenomatous polyposis coli May have colon intact 10-40 duodenal polyps from second portion to 10 cm distal to papilla of Vater PATIENT CHARACTERISTICS: Age: 18 to 80 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Hemoglobin at least 10 g/dL Platelet count at least 100,000/mm^3 No active hematologic disease Hepatic: AST and ALT less than 1.5 times upper limit of normal (ULN) Alkaline phosphatase less than 1.5 times ULN No active hepatic disease Renal: Creatinine less than 1.5 mg/dL No active renal disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active peptic ulcer disease No serious underlying medical or psychiatric illness that would preclude completion of the study or limit survival No prisoners or institutionalized patients No known allergy to sulindac or related compounds No active internal malignancy within the past 5 years No alcohol or drug abuse within the past 5 years PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other: No prior non-steroidal anti-inflammatory drugs (NSAIDs) or salicylates more than 10 days a month for the past 3 months No concurrent NSAIDs (e.g., mesalamine, olsalazine, azodisalicylate, salsalate, sulfasalazine) Aspirin for cardiac reasons allowed (81 mg/day or 325 mg twice/week)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: exisulind|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon cancer, rectal cancer, small intestine cancer