Exisulind in Preventing Polyps in Patients With Familial Adenomatous Polyposis

Utah System of Higher Education (USHE)

Status and phase

Withdrawn

Phase 3

Phase 2

Conditions

Small Intestine Cancer

Colorectal Cancer

Treatments

Drug: exisulind

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00026468

CDR0000069032

P30CA042014 (U.S. NIH Grant/Contract)

UUMC-IRB-5999-96

NCI-H01-0079

R01CA080852 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)