Exisulind in Preventing Polyps in Patients With Familial Adenomatous Polyposis

This study has been withdrawn prior to enrollment.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

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 Intervention Phase
Colorectal Cancer
Small Intestine Cancer
Drug: exisulind
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Chemoprevention of Duodenal Polyps in Familial Adenomatous Polyposis

Resource links provided by NLM:

Further study details as provided by University of Utah:

Enrollment: 0
Study Start Date: July 1999
Study Completion Date: July 1999
Primary Completion Date: July 1999 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00026468

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

ClinicalTrials.gov Identifier: NCT00026468     History of Changes
Other Study ID Numbers: CDR0000069032  R01CA080852  P30CA042014  UUMC-IRB-5999-96  NCI-H01-0079 
Study First Received: November 9, 2001
Last Updated: July 23, 2013
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on May 26, 2016