Exisulind in Preventing Polyps in Patients With Familial Adenomatous Polyposis

• Status: Withdrawn
• Trial end date: 1999-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Collaborator: National Cancer Institute (NCI)
• Treatments: Sulindac sulfone

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)