IRB Number:

06-002185

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

The purpose of this study is to find out what effects (good and bad) sulindac (CLINORIL®) has on patients and their risk of developing lung cancer.

Who is Eligible to Participate in the Study?

• Men and women 40 to 79 years of age who have a history of smoking ≥ 30 pack-years .


• Both current and former smokers are eligible. Other criteria includes:


• No prior lung cancer, or Stage I non-small cell lung cancer (NSCLC) treated with surgery at least one year prior to study registration, or Stage I non-small cell lung cancer (NSCLC) with at least one year since the conclusion of adjuvant chemotherapy.


• Presence of mild, moderate or severe dysplasia as detected by EITHER recent biopsy OR sputum testing.

Minimum Age:

45

Maximum Age:

79

What is Involved With this Study?

• Medical history


• Sputum collection test


• Physical exam


• Vital signs, body height and weight, and oxygen level


• Chest X-ray


• ECG


• Bronchoscopy and biopsies


• Blood tests


• Pregnancy test for women able to become pregnant


• Medications: Study participants will be randomly assigned (by chance) to 2 groups and receive either sulindac or placebo (inactive pill) taken in pill form.

These tests and procedures can be done as an outpatient.

How long will the Study run?

You will be in the study for 6 months.

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, or e-mail cancerclinicaltrials@mayo.edu


• 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

Last updated: 11/19/2009