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