Exisulind in Preventing Polyps in Patients With Familial Adenomatous Polyposis

Sponsor

University of Utah (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00026468

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Small Intestine Cancer	Drug: exisulind	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

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 :

Jul 1, 1999

Actual Primary Completion Date :

Jul 1, 1999

Actual Study Completion Date :

Jul 1, 1999

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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)