Spots Global Cancer Trial Database for Ursodiol in Treating Patients With Barrett Esophagus and Low-Grade Dysplasia

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Trial Identification

Brief Title: Ursodiol in Treating Patients With Barrett Esophagus and Low-Grade Dysplasia

Official Title: Clinical Study of Ursodeoxycholic Acid in Barrett's Patients

Study ID: NCT01097304

Conditions

Barrett Esophagus

Esophageal Carcinoma

Interventions

Ursodiol

Laboratory Biomarker Analysis

Study Description

Brief Summary: This pilot phase II trial studies how well ursodiol works in treating patients with Barrett esophagus or cells that look abnormal under a microscope but are not cancer (low-grade dysplasia). Chemoprevention is the use of certain drugs to keep cancer from forming. The use of ursodiol may keep cancer for forming in patients with Barrett esophagus or low-grade dysplasia.

Detailed Description: PRIMARY OBJECTIVES: I. To evaluate the ability of UDCA (ursodiol) treatment to reverse oxidative deoxyribonucleic acid (DNA) damage in the esophageal epithelium of subjects with Barrett's esophagus. SECONDARY OBJECTIVES: I. To determine the effects of UDCA treatment on gastric bile acid composition and on cell proliferation in Barrett's epithelium. OUTLINE: Patients receive ursodiol orally (PO) twice daily (BID) for 6 months in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up for 2 weeks.