Pioglitazone Hydrochloride in Treating Patients With Stage IA-IIIA Non-small Cell Lung Cancer
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.
Checked against the public recordLast updated Dec 5, 2017 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- National Cancer Institute (NCI)
- Interventions being studied
- Other: Laboratory Biomarker Analysis; Drug: Pioglitazone Hydrochloride; Other: Quality-of-Life Assessment
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Mayo ClinicRochester, Minnesota
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 5, 2017. Always confirm current availability with the study team.