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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00474903
First received: May 16, 2007
Last updated: June 2, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Barrett Esophagus
Esophageal Cancer
Drug: acetylsalicylic acid
Drug: esomeprazole magnesium
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Randomized, Double-Blinded Phase II Trial of Esomeprazole Versus Esomeprazole + Two Doses of Aspirin in Barrett's Esophagus Patients

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Change in Mean Tissue Prostaglandin E2 (PGE2) Concentration as Determined From Barrett's Research Mucosal Biopsy Samples [ Time Frame: Baseline to 30 days after completion of study treatment ] [ Designated as safety issue: No ]
    The mean tissue PGE2 is reported for each Arm.


Secondary Outcome Measures:
  • Toxicity [ Time Frame: Up to 30 days after completion of study treatment ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 122
Study Start Date: April 2007
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I (placebo, esomeprazole magnesium)
Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).
Drug: esomeprazole magnesium
Given orally
Other: placebo
Given orally
Experimental: Arm II (low-dose aspirin, esomeprazole magnesium)
Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).
Drug: acetylsalicylic acid
Given orally
Drug: esomeprazole magnesium
Given orally
Other: placebo
Given orally
Experimental: Arm III (higher-dose aspirin, esomeprazole magnesium)
Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).
Drug: acetylsalicylic acid
Given orally
Drug: esomeprazole magnesium
Given orally
Other: placebo
Given orally

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474903

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Investigators
Principal Investigator: Paul Limburg Mayo Clinic
  More Information

No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00474903     History of Changes
Other Study ID Numbers: NCI-2009-00838, NCI-2009-00838, MAY04-4-01, CDR0000544180, MAYO-MAY04-4-01, MAY04-4-01, N01CN35000
Study First Received: May 16, 2007
Results First Received: January 8, 2014
Last Updated: June 2, 2014
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Additional relevant MeSH terms:
Esophageal Neoplasms
Barrett Esophagus
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Abnormalities
Esomeprazole
Aspirin
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents

ClinicalTrials.gov processed this record on October 19, 2014