Esophageal Cancer Clinical Trial
Official title:
Phase IIb Chemoprevention Trial of Difluoromethylornithine (DFMO) in Human Subjects With Intestinal-type Barrett's Esophagus
RATIONALE: Chemoprevention therapy is the use of drugs to try and prevent the development or
recurrence of cancer. It is not known whether eflornithine is effective in preventing cancer
in patients with Barrett's esophagus.
PURPOSE: Randomized double-blinded phase II trial to study the effectiveness of eflornithine
in preventing cancer in patients with Barrett's esophagus.
OBJECTIVES: I. Determine whether oral eflornithine (DFMO) given in this study will cause
significant reduction of the Ki67 labelling index in subjects with intestinal type Barrett's
esophagus and low grade dysplastic Barrett's esophagus. II. Determine whether oral DFMO will
alter the pathology and morphology of Barrett's esophagus. III. Determine whether there is a
difference in cellular DNA ploidy and/or nuclear or nucleolar morphometry in patients with
dysplastic Barrett's esophagus and nondysplastic intestinal type Barrett's esophagus
compared to normal gastric fundic mucosa. Determine whether DFMO modulates changes in these
surrogate endpoint biomarkers towards normal mucosal values. IV. Determine whether cells
demonstrating nuclear p53 protein accumulation are either lost or undergo a change in
cellular distribution, following treatment of patients with dysplastic Barrett's mucosa with
DFMO. V. Determine whether DFMO modulates changes in growth factor or oncogene expression in
dysplastic Barrett's esophagus and nondysplastic intestinal type Barrett's esophagus. VI.
Determine whether pathologic or biologic surrogate modulation occurring during 6 months of
DFMO treatment reverts 6 months after treatment is discontinued.
OUTLINE: This is a randomized, placebo controlled, double blind prevention study. Patients
are initially stratified by dysplasia status at baseline (metaplastic vs low grade
dysplastic) and treatment group (placebo vs eflornithine). Patients are randomized to
receive daily doses of eflornithine (DFMO) or placebo for 26 weeks. At 0, 4, 8, 12, 16, 20,
and 26 weeks there are toxicity and adherence evaluations and at weeks 26 and 52 patients
have follow-up endoscopies.
PROJECTED ACCRUAL: A total of a 152 evaluable patients will be accrued in this study.
;
Primary Purpose: Prevention
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