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Exisulind in Preventing Polyps in Patients With Familial Adenomatous Polyposis
study id #: NCT00026468
condition: Colorectal Cancer, Small Intestine Cancer
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.
intervention: Drug: exisulind
start date: July 1999
estimated completion: July 1999
last updated: July 24, 2013
phase of development: Phase 2, Phase 3
Intervention Model: Single Group Assignment
Primary Purpose: Prevention
- 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.
DISEASE CHARACTERISTICS: - One of the following diagnosis:
1. Diagnosis of familial adenomatous polyposis
a. Prior total or subtotal colectomy
2. Attenuated adenomatous polyposis coli
a. May have colon intact
- 10-40 duodenal polyps from second portion to 10 cm distal to papilla of Vater
-Age: - 18 to 80
-Performance status: - Not specified
-Life expectancy: - Not specified
-Hematopoietic: 1. Hemoglobin at least 10 g/dL 2. Platelet count at least 100,000/mm^3 3. No active hematologic disease
- Hepatic: 1. AST and ALT less than 1.5 times upper limit of normal (ULN) 2. Alkaline phosphatase less than 1.5 times ULN 3. No active hepatic disease
- Renal: 1. Creatinine less than 1.5 mg/dL 2. No active renal disease
- Other: 1. Not pregnant or nursing 2. Negative pregnancy test 3. Fertile patients must use effective contraception 4. No active peptic ulcer disease 5. No serious underlying medical or psychiatric illness that would preclude completion of the study or limit survival 6. No prisoners or institutionalized patients 7. No known allergy to sulindac or related compounds 8.No active internal malignancy within the past 5 years 9. 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: 1. No prior non-steroidal anti-inflammatory drugs (NSAIDs) or salicylates more than 10 days a month for the past 3 months 2. No concurrent NSAIDs (e.g., mesalamine, olsalazine, azodisalicylate, salsalate, sulfasalazine) 3. Aspirin for cardiac reasons allowed (81 mg/day or 325 mg twice/week)
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