Exisulind in Preventing Polyps in Patients With Familial Adenomatous Polyposis

Colorectal Cancer Clinical Trial

Official title:

Chemoprevention of Duodenal Polyps in Familial Adenomatous Polyposis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00026468
• Other study ID #: CDR0000069032
• Secondary ID: R01CA080852P30CA
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: November 9, 2001
• Last updated: July 23, 2013
• Start date: July 1999
• Est. completion date: July 1999

Study information

• Verified date: July 2013
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 1999
• Est. primary completion date: July 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adenomatous Polyposis Coli
• Colorectal Cancer
• Small Intestine Cancer

Intervention

Drug:
• exisulind

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	National Cancer Institute (NCI)