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This study has been withdrawn prior to enrollment.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
  Purpose

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:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  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
Investigators
Study Chair: James A. DiSario, MD University of Utah
  More Information

No publications provided

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:
Colorectal Neoplasms
Adenomatous Polyposis Coli
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Adenomatous Polyps
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Colonic Neoplasms
Neoplastic Syndromes, Hereditary
Intestinal Polyposis
Genetic Diseases, Inborn
Sulindac sulfone
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014