Pioglitazone Hydrochloride in Treating Patients With Stage IA-IIIA Non-small Cell Lung Cancer
Stopped early · Phase 2
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT01342770
- Run by
- National Cancer Institute (NCI)
- People needed
- 6
- Starts
- 2011-04-01
- Expected to finish
- 2013-02-01
- Last updated by the study team
- 2017-12-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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