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

NCT00474903 | Completed Phase 2 Results

• 5 other identifiers: NCI-2009-00838MAY04-4-01CDR0000544180MAYO-MAY04-4-01N01CN35000
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Barrett Esophagus; Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Toxicity

  Up to 30 days after completion of study treatment

Study Arms (3)

Arm I (placebo, esomeprazole magnesium)

ACTIVE COMPARATOR

Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).

Drug: esomeprazole magnesium; Other: placebo

Arm II (low-dose aspirin, esomeprazole magnesium)

EXPERIMENTAL

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; Drug: esomeprazole magnesium; Other: placebo

Arm III (higher-dose aspirin, esomeprazole magnesium)

EXPERIMENTAL

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; Drug: esomeprazole magnesium; Other: placebo

Interventions

acetylsalicylic acid DRUG

Given orally

Arm II (low-dose aspirin, esomeprazole magnesium); Arm III (higher-dose aspirin, esomeprazole magnesium)

esomeprazole magnesium DRUG

Given orally

Arm I (placebo, esomeprazole magnesium); Arm II (low-dose aspirin, esomeprazole magnesium); Arm III (higher-dose aspirin, esomeprazole magnesium)

placebo OTHER

Given orally

Arm I (placebo, esomeprazole magnesium); Arm II (low-dose aspirin, esomeprazole magnesium); Arm III (higher-dose aspirin, esomeprazole magnesium)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Falk GW, Buttar NS, Foster NR, Ziegler KL, Demars CJ, Romero Y, Marcon NE, Schnell T, Corley DA, Sharma P, Cruz-Correa MR, Hur C, Fleischer DE, Chak A, Devault KR, Weinberg DS, Della'Zanna G, Richmond E, Smyrk TC, Mandrekar SJ, Limburg PJ; Cancer Prevention Network. A combination of esomeprazole and aspirin reduces tissue concentrations of prostaglandin E(2) in patients with Barrett's esophagus. Gastroenterology. 2012 Oct;143(4):917-26.e1. doi: 10.1053/j.gastro.2012.06.044. Epub 2012 Jul 11.

  PMID: 22796132 DERIVED

MeSH Terms

Conditions

Barrett Esophagus; Esophageal Neoplasms

Interventions

Aspirin; Esomeprazole

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Paul J. Limburg, M.D., M.P.H.
• Organization: Mayo Clinic Rochester

limburg.paul@mayo.edu

Study Officials

• Paul Limburg

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2007
• First Posted: May 17, 2007
• Study Start: April 1, 2007
• Primary Completion: March 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 2, 2014
• Results First Posted: July 2, 2014

Record last verified: 2014-01

Locations

US (1)