Esomeprazole Magnesium With or Without Aspirin in Preventing Esophageal Cancer in Patients With Barrett Esophagus

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