Exisulind in Preventing Polyps in Patients With Familial Adenomatous Polyposis

This study has been withdrawn prior to enrollment.
(Principle Investigator has left the University.)
Sponsor:
Collaborator:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00026468
First received: November 9, 2001
Last updated: July 23, 2013
Last verified: July 2013

November 9, 2001
July 23, 2013
July 1999
July 1999   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00026468 on ClinicalTrials.gov Archive Site
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Exisulind in Preventing Polyps in Patients With Familial Adenomatous Polyposis
Chemoprevention of Duodenal Polyps in Familial Adenomatous Polyposis

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Colorectal Cancer
  • Small Intestine Cancer
Drug: exisulind
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
July 1999
July 1999   (final data collection date for primary outcome measure)

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)
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00026468
CDR0000069032, R01CA080852, P30CA042014, UUMC-IRB-5999-96, NCI-H01-0079
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Not Provided
University of Utah
National Cancer Institute (NCI)
Study Chair: James A. DiSario, MD University of Utah
University of Utah
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP