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

Completed · Phase 2 · Has a placebo group

Conditions studied: Barrett Esophagus, Esophageal Cancer

In brief

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.

Key facts

Study ID

NCT00474903

Run by

National Cancer Institute (NCI)

People needed

122

Starts

2007-04-01

Expected to finish

2011-06-01

Last updated by the study team

2014-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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