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Exisulind in Preventing Polyps in Patients With Familial Adenomatous Polyposis

Primary Purpose

Colorectal Cancer, Small Intestine Cancer

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
exisulind
Sponsored by
University of Utah
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring colon cancer, rectal cancer, small intestine cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 9, 2001
    Last Updated
    July 23, 2013
    Sponsor
    University of Utah
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00026468
    Brief Title
    Exisulind in Preventing Polyps in Patients With Familial Adenomatous Polyposis
    Official Title
    Chemoprevention of Duodenal Polyps in Familial Adenomatous Polyposis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2013
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Principle Investigator has left the University.
    Study Start Date
    July 1999 (undefined)
    Primary Completion Date
    July 1999 (Actual)
    Study Completion Date
    July 1999 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Utah
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer, Small Intestine Cancer
    Keywords
    colon cancer, rectal cancer, small intestine cancer

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    exisulind

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    James A. DiSario, MD
    Organizational Affiliation
    University of Utah
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Exisulind in Preventing Polyps in Patients With Familial Adenomatous Polyposis

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