Status:
COMPLETED
Pioglitazone for Lung Cancer Chemoprevention
Lead Sponsor:
VA Office of Research and Development
Conditions:
Lung Cancer
Endobronchial Dysplasia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 sput...
Detailed Description
This trial evaluates the oral peroxisome proliferator-activated receptor gamma (PPARgamma) agonist pioglitazone in a double-blind placebo controlled trial. The high risk current and former smokers qua...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00780234
Start Date
August 1 2009
End Date
August 1 2017
Last Update
April 11 2019
Active Locations (2)
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1
VA Eastern Colorado Health Care System, Denver, CO
Denver, Colorado, United States, 80220
2
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, United States, 37212-2637