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Chemoprevention of Duodenal Polyps in Familial Adenomatous Polyposis


Phase 2/Phase 3
18 Years
80 Years
Not Enrolling
Both
Colorectal Cancer, Small Intestine Cancer

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Trial Information

Chemoprevention of Duodenal Polyps in Familial Adenomatous Polyposis


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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

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

Principal Investigator

James A. DiSario, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Utah

Authority:

United States: Federal Government

Study ID:

CDR0000069032

NCT ID:

NCT00026468

Start Date:

July 1999

Completion Date:

July 1999

Related Keywords:

  • Colorectal Cancer
  • Small Intestine Cancer
  • colon cancer
  • rectal cancer
  • small intestine cancer
  • Colorectal Neoplasms
  • Adenomatous Polyposis Coli
  • Duodenal Neoplasms
  • Ileal Neoplasms
  • Jejunal Neoplasms
  • Intestinal Neoplasms

Name

Location

Huntsman Cancer InstituteSalt Lake City, Utah  84112