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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Dec 5, 2017 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
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
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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.