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Pioglitazone for Lung Cancer Chemoprevention

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00780234
First received: October 24, 2008
Last updated: March 28, 2016
Last verified: March 2016

October 24, 2008
March 28, 2016
August 2009
June 2016   (final data collection date for primary outcome measure)
Changes in endobronchial histology [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00780234 on ClinicalTrials.gov Archive Site
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Pioglitazone for Lung Cancer Chemoprevention
Pioglitazone for Lung Cancer Chemoprevention
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.
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 qualify based on tobacco exposure, airflow limitation on lung function testing, and sputum cytologic atypia. Subjects have a quantitative high resolution thoracic CT scan and a fluorescent bronchoscopy at study entry and after 6 months on drug or placebo. Biologic samples are collected at both time points. The primary outcome is endobronchial histology and determining if pioglitazone can retard progression. Secondary endpoints related to the PPAR gamma signaling pathway will also be analyzed.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Lung Cancer
  • Endobronchial Dysplasia
  • Procedure: fluorescence bronchoscopy
    examination of the central airways with a bronchoscope. Both white light and fluorescent light will be used.
  • Procedure: quantitative high resolution CT scan
    High resolution CT scan of the chest
  • Drug: PIOGLITAZONE VS. PLACEBO 30 mg

    Patients will be randomized to receive either pioglitazone or placebo. Pioglitazone hydrochloride, a thiazolidinedione antidiabetic agent and a potent peroxisome proliferator-

    activated receptor-gamma agonist. It is FDA approved for the treatment of Type II diabetes. It has been previously administered to non-diabetic subjects. The most common side effect of pioglitazone is fluid retention and modest weight gain. There is a potential risk that pioglitazone may cause an elevation in liver enzymes and more serious hepatotoxicity (rare). There is risk of edema and weight gain associated with pioglitazone therapy. 5% experienced peripheral edema in clinical trials. fluid retention may result in new onset heart failure or exacerbation of existing heart failure. Small risk of hypoglycemia, anemia, myalgia, bone fracture, headache, and macular retinal edema exists. There is insufficient information to confirm its safety in Pregnancy/Breastfeeding. Bladder cancer is more serious but rare.

  • Experimental: Arm 1: pioglitazone
    Current or former smokers receive 6 months of treatment with pioglitazone
    Interventions:
    • Procedure: fluorescence bronchoscopy
    • Procedure: quantitative high resolution CT scan
    • Drug: PIOGLITAZONE VS. PLACEBO 30 mg
  • Placebo Comparator: Arm 2: placebo
    Current or former smokers receive 6 months of treatment with placebo
    Interventions:
    • Procedure: fluorescence bronchoscopy
    • Procedure: quantitative high resolution CT scan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
391
June 2016
June 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00780234
CLIN-005-08S
Yes
Not Provided
Not Provided
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Robert L. Keith, MD VA Eastern Colorado Health Care System, Denver, CO
VA Office of Research and Development
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP