A Randomized Phase II Chemoprevention Study of Pioglitazone Versus Placebo in Patients at High Risk for Lung Cancer

Objective

VA patients who are at high risk for developing lung cancer who have abnormal cells in their sputum. Patients will be randomized to take a new drug called Pioglitazone or a placebo. The study lasts for 7 months, and patients will see a doctor once amonth. They will be on the drug and/or placebo for 6 months. The following tests till be performed: Bronchoscopy (twice), routine and research blood samples, echocardiogram, chest CT. EKG, pulmonaty function test, and a carbon monoxide measurement.

IRB Protocol Number

08-0715

Principal Investigator(s)

ROBERT KEITH

Cancer Trials

• Lung Cancer

Sponsor(s)

Dept Of Veterans Affairs Medical Center

Contact

BRANDI BAGWELL at 303-724-1650
or BRANDI.BAGWELL@ucdenver.edu

Eligibility and Other Participant Information

What To Expect : Pioglitazone or a placebo. The study lasts for 7 months, and patients will see a doctor once amonth. They will be on the drug and/or placebo for 6 months. The following tests till be performed: Bronchoscopy (twice), routine and research blood samples, echocardiogram, chest CT. EKG, pulmonaty function test, and a carbon monoxide measurement. // Eligibility criteria : Adult > 18 years of age. A current or ex-smoker with a > 20 pack-year history of smoking. (An ex-smoker is defined as no tobacco use in the prior 6 months.). Mild or worse sputum cytologic atypia or endobronchial dysplasia on a previous bronchoscopy. At least mild airflow limitation on pulmonary function testing (FEV1/FVC<70% actual). Participants must have normal blood counts as described in the protocol. Participants must have a an adequate preformance status. Participants must have a echocardiogram within normal limits within the last year. Participants must not have pneumonia or acute bronchitis for at least 2 weeks prior to enrollment. Participants must be able and willing to undergo a bronchoscopy before and after treatment for 6 months. Participants of child-bearing age must use appropriate contraception (barrier, hormonal or post-menopausal) until one month after study medication ends. Patients must be fully informed of the investigational nature of this study and must sign an nformed consent .