Ursodiol in Treating Patients With Barrett Esophagus and Low-Grade Dysplasia
Condition: Barrett Esophagus; Esophageal Carcinoma
MeSH terms: Barrett Esophagus; Esophageal Neoplasms
Intervention: Ursodiol; Laboratory Biomarker Analysis
Intervention description: Given PO; Correlative studies
Intervention MeSH terms: Ursodeoxycholic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Barrett's esophagus with histologically-confirmed intestinal metaplasia
             anywhere in the tubular esophagus either with >= 2 cm of involvement or with a minimum
             circumferential Barrett's esophagus (BE) length of 1 cm

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1

          -  Leukocytes >= 3,000/uL

          -  Absolute neutrophil count >= 1,500/uL

          -  Platelets >= 100,000/uL

          -  Total bilirubin =< 2.0 mg/dL

          -  Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT])
             =< 2 X institutional upper limit of normal (ULN)

          -  Creatinine =< 1X ULN

          -  Women of child-bearing potential (i.e., not surgically sterile or less than one year
             since last menstrual period) agree to use adequate contraception (hormonal or barrier
             method of birth control; abstinence) prior to study entry and for the duration of
             study participation; women of childbearing potential must have a negative urine
             pregnancy test within 14 days prior to study agent administration; male subjects must
             agree to use adequate contraception (barrier method, abstinence, subject has had
             vasectomy or partner is using effective birth control or is postmenopausal)

          -  Ability to understand and the willingness to sign a written informed consent document

          -  Agree to refrain from any non-steroidal anti-inflammatory drug (NSAID) with the
             exception of low-dose aspirin (81 mg once daily [QD]) during the entire study period

          -  Agree not to take aluminum-containing antacids and anion exchange resins such as
             cholestyramine, colestimide or colestipol within 2 hours of taking UDCA

        Exclusion Criteria:

          -  Barrett's esophagus with high grade dysplasia or carcinoma at enrollment

          -  Medical conditions which would make completing endoscopies or completing the trial
             difficult including but not limited to previous transient ischemic attacks or cerebral
             vascular disease, severe respiratory disease, severe ischemic heart disease or
             myocardial infarction in the previous 6 months, inflammatory bowel disease

          -  Participants may not be receiving any other investigational agents within 1 month of
             study enrollment

          -  Have used NSAID for more than 5 days per month within 1 month of enrollment except low
             dose aspirin (81 mg QD)

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to UDCA

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Pregnant and breastfeeding women are excluded from this study; breastfeeding should be
             discontinued during treatment; should a woman become pregnant or suspect she is
             pregnant while participating in this study, she should inform her study physician
             immediately

          -  Have had major upper gastrointestinal (GI) surgeries within 6 months of enrollment
             including, but not limited to, fundoplication, bariatric surgery, cholecystectomy

          -  Erosive esophagitis detected at the baseline endoscopy

          -  Participants who need concurrent chemotherapy, radiotherapy, or cancer-related
             hormonal or immunotherapy during the time of study

          -  Participants who have had chemotherapy, radiotherapy, or cancer-related hormonal or
             immunotherapy within 18 months of the baseline visit

          -  Current or planned use of anticoagulant drugs including, but not limited to, warfarin,
             heparin, low molecular weight heparin, Plavix, or Aggrenox

          -  Use of cyclosporine during the time of study