Exisulind in Preventing Polyps in Patients With Familial Adenomatous Polyposis

Overview

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.

Full Title of Study: “Chemoprevention of Duodenal Polyps in Familial Adenomatous Polyposis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: Double
  • Study Primary Completion Date: July 1999

Detailed 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.

Interventions

  • Drug: exisulind

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Utah
  • Collaborator
    • National Cancer Institute (NCI)
  • Overall Official(s)
    • James A. DiSario, MD, Study Chair, University of Utah

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