Pioglitazone Hydrochloride in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
I. To evaluate the mechanism(s) of action of pioglitazone as a candidate chemopreventive
agent for lung cancer by investigating the effects on Ki-67 defined in non-small cell lung
cancer (NSCLC) tumor tissue.
I. To determine the effects of pioglitazone on multiple markers listed below:
- Tumor tissue: caspase-3, cyclin D1, p21/Waf1, PPARγ, MUC1.
- Premalignant tissue: Ki-67, caspase-3, PPARγ.
- Histologically normal tissue: Ki-67, PPARγ. II. To evaluate the toxicity and safety of
pioglitazone in this patient population.
III. To analyze the expression of serum markers that are affected by pioglitazone.
IV. To describe the effects of limited treatment with pioglitazone on tumor metabolic
activity as determined by FDG-PET (assessed before and after a minimum of 2 weeks of
Patients receive pioglitazone hydrochloride orally once daily for 14-42 days. Patients then
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Change in Ki-67 by IHC
Descriptive statistics will be used to summarize participant characteristics and all biomarker expression data. Changes in the expression levels of Ki-67 will be plotted graphically, and percent change in expression levels will be formally assessed using the paired t-test or the Wilcoxon signed rank test, if the assumptions of the t-test (i.e. normality) are not met. Changes in the IHC grades of Ki-67 expression from baseline to postintervention will be assessed using a McNemar's test.
From baseline to post-resection
United States: Food and Drug Administration
|Mayo Clinic||Rochester, Minnesota 55905|