Exisulind in Preventing Polyps in Patients With Familial Adenomatous Polyposis

study id #: NCT00026468

condition: Colorectal Cancer, Small Intestine Cancer

status: withdrawn

purpose:

intervention: Drug: exisulind

start date: July 1999

estimated completion: July 1999

last updated: July 24, 2013

phase of development: Phase 2, Phase 3

study design:
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention

study description:
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.

inclusion criteria:

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
PATIENT CHARACTERISTICS:
-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)

exclusion criteria: