Esomeprazole Magnesium With or Without Aspirin in Preventing Esophageal Cancer in Patients With Barrett Esophagus
Condition: Barrett Esophagus; Esophageal Cancer
MeSH terms: Esophageal Neoplasms; Barrett Esophagus
Intervention: acetylsalicylic acid; esomeprazole magnesium; placebo
Intervention description: Given orally; Given orally; Given orally
Intervention MeSH terms: Aspirin; Esomeprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial is studying the effect of esomeprazole magnesium and aspirin
      on tissue PGE2 levels compared with esomeprazole and placebo. This type of chemoprevention
      treatment investigates the use of certain drugs to assess whether they assist in the
      prevention of cancer. The use of esomeprazole magnesium with or without aspirin may help
      prevent esophageal cancer in patients with Barrett esophagus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed Barrett esophagus, meeting all of the following criteria:

               -  Presence of specialized columnar epithelium anywhere in the tubular esophagus
                  with ≥ 2 cm of circumferential involvement

               -  No evidence of high-grade dysplasia or cancer by esophagogastroduodenoscopy (EGD)

               -  No prior histologically confirmed esophageal dysplasia, including cancer

          -  Adequate Barrett mucosa, defined as ≥ 4 of 8 research samples with≥ 50% intestinal
             metaplasia in research biopsies

          -  No ulcer, erosion, plaque, nodule, stricture, or other luminal irregularity within the
             Barrett's segment or erosive esophagitis (Los Angeles classification > grade A)
             detected at pre-intervention EGD exam

          -  Eastern Cooperative Group (ECOG) performance status 0-2

          -  Hemoglobin normal

          -  Platelet count ≥ 100,000/mm³

          -  Aspartate aminotransferase (AST) ≤ 2.5 times upper limit of normal (ULN)

          -  Alkaline phosphatase ≤ 2.5 times ULN

          -  Bilirubin ≤ 2.5 times ULN

          -  Creatinine ≤ 2.5 times ULN

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No nasal polyps associated with asthma or induced or exacerbated by aspirin

          -  No malignancy within the past 5 years except for nonmelanoma skin cancer

          -  No history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to the study agents or rescue medication

          -  No history of endoscopically or radiographically diagnosed peptic ulcer disease
             (bleeding or nonbleeding)

          -  No other uncontrolled illness including, but not limited to, any of the following:

               -  Ongoing or active infection

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Cardiac arrhythmia

               -  Bleeding disorder

               -  Vitamin K deficiency

               -  Alcohol abuse (defined as ingestion of ≥ 3 drinks per day)

               -  Psychiatric illness or social situations that would limit study compliance

          -  At least 3 months since prior chronic use (defined as ≥ 7 days during the 3 months
             preceding the beginning of the Run-in phase) of acetylsalicylic acid (aspirin),
             nonsteroidal antiinflammatory drug (NSAIDs), or selective cyclooxygenase (COX-2)
             inhibitors

          -  At least 3 months since prior investigational agents except innocuous agents with no
             known interaction with the study agents (e.g., standard dose multivitamins or topical
             agents for limited skin conditions)

          -  No prior fundoplication, bariatric surgery, or any other major upper gastrointestinal
             surgery

               -  Prior cholecystectomy allowed

          -  No other concurrent NSAIDs (including aspirin) or selective COX-2 inhibitor therapy

          -  No concurrent anticoagulant drugs including, but not limited to, any of the following:

               -  Warfarin

               -  Heparin

               -  Low-molecular weight heparin

               -  Clopidogrel bisulfate

               -  Extended-release dipyridamole