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Pioglitazone Hydrochloride in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer

18 Years
Not Enrolling
Stage IA Non-small Cell Lung Cancer, Stage IB Non-small Cell Lung Cancer, Stage IIA Non-small Cell Lung Cancer, Stage IIB Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer

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Trial Information

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
undergo surgery.

Inclusion Criteria:

- Suspected or biopsy-proven NSCLC

- Willingness to provide biopsy tissue for correlative studies

- Candidate for pulmonary resection; must be able to schedule >= 14 days and =< 42 days
between registration and surgery to allow for treatment with pioglitazone

- Ability to understand and the willingness to sign a written informed consent document

- Ability and willingness to swallow oral tablets

- Ability and willingness to undergo two bronchoscopies (before treatment and at the
time of surgery)

- For those participants who are undergoing mediastinoscopy as part of their
standard-of-care, the pre-treatment bronchoscopy may be performed during the
mediastinoscopy; if the participant remains eligible for definitive surgical
resection after the mediastinoscopy, the participant may proceed to registration
and pioglitazone treatment

- Current or former smoker with a >= 10 pack-year smoking history

- Women of child-bearing potential and men who agree to use adequate contraception for
the duration of study participation; the effects of pioglitazone on the developing
human fetus at the recommended therapeutic dose are unknown; for this reason, women
must not be pregnant or lactating. Women of child-bearing potential (women considered
not of childbearing potential if they are at least two years postmenopausal and/or
surgically sterile) must have used adequate contraception (abstinence; barrier
methods such as IUD, diaphragm with spermicidal gel, condom, or others; and hormonal
methods such as birth control pills or others) since her last menses prior to study
entry; should a woman become pregnant or suspect she is pregnant while participating
in this study, she should inform her study physician immediately

Exclusion Criteria:

- Receiving any other investigational agents

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to pioglitazone

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Pregnant or lactating woman

- Currently treated diabetes

- Participants with >= class II NYHA congestive heart failure or history of congestive
heart failure

- Participants with >= grade 2 (moderate) edema

- Participants currently receiving an inhibitor of CYP2C8 (gemfibrozil, ketoconazole,
quercetin, trimethoprim), or an inducer of CYP2C8 (cortisol, dexamethasone,
phenobarbital, rifampin), or CYP3A4 substrate

- Prior neoadjuvant therapy for NSCLC

- History of bladder cancer or in situ bladder cancer

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in Ki-67 by IHC

Outcome Description:

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.

Outcome Time Frame:

From baseline to post-resection

Safety Issue:


Principal Investigator

Dennis Wigle

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

April 2011

Completion Date:

Related Keywords:

  • Stage IA Non-small Cell Lung Cancer
  • Stage IB Non-small Cell Lung Cancer
  • Stage IIA Non-small Cell Lung Cancer
  • Stage IIB Non-small Cell Lung Cancer
  • Stage IIIA Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Mayo Clinic Rochester, Minnesota  55905