Chemoprevention of Duodenal Polyps in Familial Adenomatous Polyposis

Inclusion Criteria

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)