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.

Condition	Treatment or Intervention	Phase
Colon Cancer Rectal Cancer small intestine cancer	Drug: exisulind  Procedure: cancer prevention intervention  Procedure: chemoprevention of cancer	Phase II Phase III

Further Study Details: 

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 will be 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 3 years.

PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

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)

Utah
      Huntsman Cancer Institute, Salt Lake City,  Utah,  84112,  United States

Study chairs or principal investigators

James Anthony DiSario, MD,  Study Chair,  Huntsman Cancer Institute   

Study ID Numbers:  CDR0000069032; UUMC-IRB-5999-96; NCI-H01-0079
Record last reviewed:  September 2003
Last Updated:  October 13, 2004
Record first received:  November 9, 2001
ClinicalTrials.gov Identifier:  NCT00026468
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08