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A Phase III Randomized, Double-Blind, Placebo-Controlled Clinical Trial of the Combination of DFMO and Sulindac to Decrease the Rate of Recurrence of Adenomatous Polyps in the Colon


Phase 3
40 Years
80 Years
Not Enrolling
Both
Precancerous Condition

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Trial Information

A Phase III Randomized, Double-Blind, Placebo-Controlled Clinical Trial of the Combination of DFMO and Sulindac to Decrease the Rate of Recurrence of Adenomatous Polyps in the Colon


PRIMARY OBJECTIVES:

I. Compare the rate of new adenomatous polyp formation in patients with a history of
adenomatous polyps of the colon treated with eflornithine and sulindac vs placebo.

II. Correlate the effects of eflornithine and sulindac on polyamine and prostaglandin
content in the flat mucosa with the rate of new adenoma formation in these patients.

III. Compare the rate of side effects in patients treated with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to participating center and aspirin use (yes vs no).

Patients receive oral double placebo once daily for 4 weeks. Patients who are more than 70%
compliant by pill measurement or self reporting are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral double placebo once daily.

Arm II: Patients receive oral eflornithine (DFMO) and oral sulindac once daily.

In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or
the development of an invasive malignancy.

Inclusion Criteria


Criteria:

- History of >= 1 surgically resected adenomatous polyp of the colon measuring >= 3 mm
within the past 5 years

- Screening colonoscopy performed within the past 6 months

- All polyps must have been removed during colonoscopy, pathologically examined, and
archived

- No prior surgical resection removing > 40 cm of the colon

- No personal or family history of familial polyposis or hereditary non-polyposis colon
cancer

- SWOG 0-1

- Bilirubin =< 2.0 mg/dL

- AST and ALT =< 2 times normal

- Creatinine =< 1.5 mg/dL

- Urine protein =<, urine casts 0-3, urine WBC and RBC count 0-5 cells by urinalysis

- No history of inflammatory bowel disease

- No gastric or duodenal ulcers within the past 12 months

- Gastric or duodenal ulcers that were adequately treated > 24 months ago are allowed

- No symptomatic gastric or duodenal ulcers

- Not pregnant or nursing

- Negative pregnancy test

- Must have regional geographic stability over the next 36 months

- Pure tone audiometry evaluation normal

- Patients with >= 20 dB of uncorrectable hearing loss (for age) of any 2 contiguous
frequencies are not allowed

- No invasive malignancy within the past 5 years except adequately treated nonmelanoma
skin cancer, level I (or Breslow < 0.76 mm) cutaneous melanoma, Duke's A colon
cancer, stage I cervical cancer, or stage 0 chronic lymphocytic leukemia

- No severe metabolic disorder

- No other significant acute or chronic disease that would preclude study participation

- No history of abnormal wound healing or repair

- No conditions that would confer risk of abnormal wound healing or repair

- No history of allergy to NSAIDs or eflornithine

- No concurrent chemotherapy

- No concurrent corticosteroids on a regular or predictable intermittent basis

- No concurrent radiotherapy

- Concurrent calcium supplements (=< 1,000 mg/day) allowed

- Concurrent lipid-lowering drugs (i.e., high-dose statins) allowed

- No other concurrent nonsteroidal anti-inflammatory drugs (NSAIDs) on a regular or
predictable intermittent basis

- Concurrent aspirin for cardiovascular prophylaxis (i.e., 81 mg/day) allowed

- No concurrent anticoagulants on a regular or predictable intermittent basis

- No concurrent treatment for gastric or duodenal ulcers

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Rate of new adenomatous polyp formation

Outcome Description:

Fisher's exact test will be used to compare treatment groups with regard to the proportions of patients with at least one new adenoma. Ninety-five percent confidence intervals for the proportion of recurrent adenomas will be computed for each treatment group. For multivariate analyses, logistic regression will be used to model the presence of at least one adenoma.

Outcome Time Frame:

Up to 36 months

Safety Issue:

No

Principal Investigator

Frank Meyskens

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California Medical Center At Irvine-Orange Campus

Authority:

United States: Institutional Review Board

Study ID:

NCI-2009-00880

NCT ID:

NCT00118365

Start Date:

July 1998

Completion Date:

Related Keywords:

  • Precancerous Condition
  • Precancerous Conditions

Name

Location

University of California Medical Center At Irvine-Orange CampusOrange, California  92868