Esophageal Cancer Clinical Trial
Official title:
Randomized, Double-Blinded Phase II Trial of Esomeprazole Versus Esomeprazole + Two Doses of Aspirin in Barrett's Esophagus Patients
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.
Status | Completed |
Enrollment | 122 |
Est. completion date | June 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Mean Tissue Prostaglandin E2 (PGE2) Concentration as Determined From Barrett's Research Mucosal Biopsy Samples | The mean tissue PGE2 is reported for each Arm. | Baseline to 30 days after completion of study treatment | No |
Secondary | Toxicity | Toxicity is defined as adverse events that are classified as either possibly, probably, or definitely related to the interventional agent, graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The number of patients reporting adverse events will be tabulated by grade. | Up to 30 days after completion of study treatment | Yes |
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