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Trial record 33 of 4147 for:    colon cancer AND Intestinal Neoplasms

Exisulind in Preventing Polyps in Patients With Familial Adenomatous Polyposis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00026468
Recruitment Status : Withdrawn (Principle Investigator has left the University.)
First Posted : January 27, 2003
Last Update Posted : July 24, 2013
National Cancer Institute (NCI)
Information provided by:
University of Utah

Brief 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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Small Intestine Cancer Drug: exisulind Phase 2 Phase 3

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Chemoprevention of Duodenal Polyps in Familial Adenomatous Polyposis
Study Start Date : July 1999
Actual Primary Completion Date : July 1999
Actual Study Completion Date : July 1999

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 to 80

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Hemoglobin at least 10 g/dL
  • Platelet count at least 100,000/mm^3
  • No active hematologic disease


  • 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


  • Creatinine less than 1.5 mg/dL
  • No active renal disease


  • 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


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • Not specified


  • Not specified


  • See Disease Characteristics


  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00026468

Sponsors and Collaborators
University of Utah
National Cancer Institute (NCI)
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Study Chair: James A. DiSario, MD University of Utah

Layout table for additonal information Identifier: NCT00026468     History of Changes
Other Study ID Numbers: CDR0000069032
R01CA080852 ( U.S. NIH Grant/Contract )
P30CA042014 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 24, 2013
Last Verified: July 2013

Keywords provided by University of Utah:
colon cancer
rectal cancer
small intestine cancer

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Intestinal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Syndromes, Hereditary
Intestinal Polyposis
Adenomatous Polyposis Coli
Digestive System Diseases
Gastrointestinal Diseases
Rectal Diseases
Adenomatous Polyps
Genetic Diseases, Inborn
Sulindac sulfone
Antineoplastic Agents
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic