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Pioglitazone for Lung Cancer Chemoprevention


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer, Endobronchial Dysplasia

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Trial Information

Pioglitazone for Lung Cancer Chemoprevention


This trial evaluates the oral PPAR gamma 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.


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:

- MI with ejection fraction < 50%;

- severe/unstable angina;

- history of coronary or peripheral arterial bypass grafting;

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Changes in endobronchial histology

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Robert L. Keith, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

VA Eastern Colorado Health Care System, Denver

Authority:

United States: Federal Government

Study ID:

CLIN-005-08S

NCT ID:

NCT00780234

Start Date:

August 2009

Completion Date:

December 2014

Related Keywords:

  • Lung Cancer
  • Endobronchial Dysplasia
  • chemoprevention
  • lung cancer
  • pioglitazone
  • Lung Neoplasms

Name

Location
VA Eastern Colorado Health Care System, Denver Denver, Colorado  80220
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN Nashville, Tennessee  37212-2637