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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Rate of new adenomatous polyp formation
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.
Up to 36 months
University of California Medical Center At Irvine-Orange Campus
United States: Institutional Review Board
|University of California Medical Center At Irvine-Orange Campus||Orange, California 92868|