Pioglitazone Hydrochloride in Treating Patients With Stage IA-IIIA Non-small Cell Lung Cancer
Condition: Stage IA Non-Small Cell Lung Carcinoma; Stage IB Non-Small Cell Lung Carcinoma; Stage IIA Non-Small Cell Lung Carcinoma; Stage IIB Non-Small Cell Lung Carcinoma; Stage IIIA Non-Small Cell Lung Cancer
MeSH terms: Carcinoma; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Laboratory Biomarker Analysis; Pioglitazone Hydrochloride; Quality-of-Life Assessment
Intervention description: Correlative studies; Given PO; Ancillary studies
Intervention MeSH terms: Pioglitazone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This pilot phase II trial studies how well pioglitazone works in treating patients with stage
      IA-IIIA non-small cell lung cancer. Pioglitazone hydrochloride may slow the growth of tumor
      cells and may be an effective treatment for non-small cell lung cancer.
    

Eligibility criteria:

        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; 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 intrauterine device [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 New York Heart Association (NYHA) congestive heart
             failure or history of congestive heart failure

          -  Participants with >= grade 2 (moderate) edema

          -  Participants currently receiving an inhibitor of cytochrome P450 family 2, subfamily
             C, polypeptide 8 (CYP2C8) (gemfibrozil, ketoconazole, quercetin, trimethoprim), or an
             inducer of CYP2C8 (cortisol, dexamethasone, phenobarbital, rifampin), or cytochrome
             P450 family 3, subfamily A, polypeptide 4 (CYP3A4) substrate

          -  Prior neoadjuvant therapy for NSCLC

          -  History of bladder cancer or in situ bladder cancer