Pioglitazone for Lung Cancer Chemoprevention

• Status: Completed
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a chemoprevention trial evaluating the diabetic agent pioglitazone. Non-diabetic subjects at risk for lung cancer (based on smoking history, lung function testing, and atypical cells in a sputum sample) receive either placebo or pioglitazone and have chest computerized tomography (CAT) scans and examinations of their airways with a bronchoscope at the start of the trial and after 6 months on treatment. Compensation will be provided to the subject after completing the trial.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Pioglitazone

Criteria

Inclusion Criteria:

• Current or former smoker (at least 10 pack years);

• One or more of the following:

• Mild or worse sputum atypia

• Airflow Limitation (FEV1/FVC<70% predicted)

• Biopsy proven airway dysplasia

Exclusion Criteria:

• myocardial infarction (MI) with ejection fraction < 50%;

• severe/unstable angina;

• history of coronary or peripheral arterial bypass grafting;

• New York Heart Association (NYHA) class III or IV congestive heart failure;

• hypoxemia (less than POX 90 with supplemental oxygen); Diabetes type I or II; severe COPD (GOLD stage III or IV); clinically significant edema requiring diuretic therapy;

• life expectancy < 6 months; history of bladder cancer

• pregnant or breast feeding; inability to give informed consent