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Clinical Trials Detail

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 .

Location

  • Dept Of Veterans Affairs Medical Center