Phase IIB Randomized, Double-Blinded, Placebo Controlled Study to Evaluate the Safety and Efficacy of Topical Difluoromethylornithine (DFMO) With and Without a Topical Corticosteroid Cream (Triamcinolone 0.1%) in the Therapy of Actinic Keratoses (AK) on the Forearms
OBJECTIVES: I. Compare the safety and efficacy of eflornithine (DFMO) vs placebo as
chemoprevention of non-melanoma skin cancer in patients with moderate to heavy actinic
keratosis (AK). II. Determine whether this drug reverses AK in these patients. III.
Determine whether triamcinolone reduces DFMO-induced skin irritation in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
randomized to 1 of 4 treatment arms. Arm I: Patients receive eflornithine (DFMO) topically
and triamcinolone topically to forearms once daily. Arm II: Patients receive DFMO and
placebo topically as in arm I. Arm III: Patients receive placebo and triamcinolone topically
as in arm I. Arm IV: Patients receive 2 placebos topically as in arm I. Treatment continues
for 6 months in the absence of unacceptable toxicity. Patients are followed at 2 weeks.
PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 1 year.
Primary Purpose: Treatment
David S. Alberts, MD
University of Arizona
United States: Federal Government
|Arizona Cancer Center||Tucson, Arizona 85724|