IRB Number:

06-003697

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

This study is being done for these reasons:
- To learn about any effects (good and bad) esomeprazole (an acid blocker) with or without aspirin has on a patient and their esophagus;
- To find out if esomeprazole and aspirin have an effect on a patient's risk for getting cancer of the esophagus;
- There are no U.S. Food and Drug (FDA) approved drugs for the prevention of esophageal cancer.
Esomeprazole is a drug which has been approved by the FDA for the treatment of gastroesophageal reflux disease (GERD) and duodenal (small intestine) ulcers. Aspirin is a drug which is used for the treatment of joint inflammation
conditions, pain, fever, strokes, and heart disease. At the present time, neither of these agents is approved for the prevention of esophageal cancer.

Who is Eligible to Participate in the Study?

-Diagnosed with Barrett's esophagus, an abnormal condition of the esophagus (the tube that carries food from the mouth to the stomach). Having this condition means that the normal lining of a person's esophagus has been damaged and changed into the type of lining that is normally found in the intestines.

*More specific, detailed eligibility and/ or exclusion criteria are associated with this trial.

What is Involved With this Study?

Before the study begins, patients will have an initial screening to be sure they are eligible to be in the study. This will include a medical history and physical exam (including body height and weight, body temperature, heart rate, blood pressure and breathing rate). Patients will have some blood drawn for research eligibility blood tests (including a pregnancy test if they are a woman able to become pregnant).

Patients will also be asked to stop taking certain medications they may be taking to help control their symptoms of GERD, such as heartburn or pain in their esophagus or stomach. Instead, patients will take esomeprazole twice a day about 20 to 60 minutes before the morning and evening meal, for 28 days. This is called the "Run-In period" of the study. If the patient's GERD symptoms come back during this time, they will be given Gelusil, which is a chewable antacid tablet. Patients will be given only one box of Gelusil and should follow the directions printed on the box, which include not taking more than 12 tablets in a 24-hour period, for no more than two weeks. No other medication except esomeprazole should be used during this time.

During this time patients will also be asked to keep a medication diary for the esomeprazole and, if taken, the Gelusil. This should be completed each day.

Patients will be asked about other medications they are taking and about any symptoms they are having. If the patient tolerated the esomeprazole and still wishes to be a part of the study, they will continue taking the esomeprazole as prescribed and have more screening. Patients will also have some blood drawn for a salicylate (aspirin) level and have a repeat pregnancy test, if applicable. Patients will be asked to give another blood sample for future research purposes. This is optional and will not affect the patient?s participation in the study.

Patients will also have another physical exam and an esophagogastroduodenoscopy, also called an "EGD", which involves placing an instrument called an endoscope into the patient's mouth, down the tube that carries food to their stomach, and passing it down into their stomach. Small samples of tissue, or biopsies, will also be taken during the EGD exam.

If the patient continues to be eligible for the study and still wishes to participate they will be "randomized" into one of the study arms described below. Randomization means that the patient is put into a group by chance. It is like flipping a coin. Neither the patient nor the researcher will choose or know what group the patient will be in. Patients have a two in three chance of being in one of the groups that will take aspirin.

Patients will be asked to take one of the following study drug combinations:
- One tablet of esomeprazole by mouth two times a day (once in the morning and once in the evening, about 20-60 minutes before eating); and two tablets of placebo by mouth in the morning with food;
- One tablet of esomeprazole by mouth two times a day (once in the morning and once in the evening, about 20-60 minutes before eating); and one 81 milligram (mg) tablet of aspirin and one tablet of placebo by mouth in the morning with food;
- One tablet of esomeprazole by mouth two times a day (once in the morning and once in the evening, about 20-60 minutes before eating); and one 325 mg tablet of aspirin and one tablet of placebo by mouth in the morning with food.

The study esomeprazole and aspirin or placebo will be taken each day for 28 days starting on Day 1. Patients will be given enough pills to last beyond their scheduled return visit. Patients will be asked to keep a medication diary for each study medication they are taking. This should be completed each day. Patients will be asked to bring both the medication diary and the medication container to their return visit on Day 28.

Patients will also be asked to complete a questionnaire about their study participation experience. This will take 5 to 10 minutes to complete.

If taking part in this study, patients will have some additional tests and procedures. These will happen at different times during the study and they can have them done as an outpatient. These tests and procedures are: physical exams, including vital signs (blood pressure, heart rate, breathing rate and body temperature), body weight, repeat blood tests, and EGD with biopsies. Patients will be asked about any other medications they are taking. Patients will also be asked about any side effects they might be having as well as their overall health and general well-being.

This study also has required laboratory tests that will be done to study small samples of tissue. The tissue sample will be collected during the EGD with biopsies taken at the end of the study. These tests will be done in order to understand how damage to the lining of the esophagus can lead to the development of cancer. These tests are for research purposes only and the patient will not have to pay for them

How long will the Study run?

After a patient has taken the esomeprazole for 28 days as part of the Run-In period and for the remaining days until the start of Day 1, patients will then be in the study for 28 days of treatment. There is no follow-up planned after the 28 days of treatment unless the patient is having side effects. If this happens, the patient will be followed by telephone until the side effects go away. Patients will also be contacted by phone to discuss their final test results

Sponsor(s): National Cancer Institute, Division of Cancer Prevention

Study Activation/Registration Date: 04/26/2007

IRB Review and Approval Date: 10/05/2006

Study Type: Prevention

Projected Accrual: The plan is to have up to 168 patients participate from multiple medical centers.

Costs of Study:There may be standard patient care costs related to participating in a cancer research study.

Principal Investigator: Yvonne Romero, M.D.

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN
• Jacksonville, FL
• Scottsdale and Phoenix, AZ

Last updated: 11/19/2009