Pioglitazone Hydrochloride in Treating Patients With Stage IA-IIIA Non-small Cell Lung Cancer
Pioglitazone as a Candidate Chemoprevention Agent for Lung Cancer: A Pilot Trial Using a Pre-surgical Model in Early Stage NSCLC
8 other identifiers
interventional
6
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 23, 2011
CompletedFirst Posted
Study publicly available on registry
April 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
October 6, 2015
CompletedDecember 5, 2017
October 1, 2017
1.7 years
April 23, 2011
September 4, 2015
October 30, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change in Ki-67 by Immunohistochemistry (IHC)
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.
Baseline and at the time of surgery, after 42 days of treatment
Secondary Outcomes (14)
Change in Apoptosis Assessment (e.g., Caspase-3)
Baseline and at the time of surgery, after 42 days of treatment
Change in Levels of Serum CA-153
Baseline and at the time of surgery, after 42 days of treatment
Change in Levels of Serum CRP
Baseline and at the time of surgery, after 42 days of treatment
Gene Expression Analysis of RNA From Bronchial Brush Cells
Up to the time of surgery, after 42 days of treatment
Incidence of Adverse Events Graded According to Common Terminology Criteria for Adverse Events Version 4.0
Up to the time of surgery, after 42 days of treatment
- +9 more secondary outcomes
Study Arms (1)
Treatment (pioglitazone hydrochloride)
EXPERIMENTALPatients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
Interventions
Given PO
Ancillary studies
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dennis Wigle, M.D., Ph.D.
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Limburg
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2011
First Posted
April 27, 2011
Study Start
April 1, 2011
Primary Completion
December 1, 2012
Study Completion
February 1, 2013
Last Updated
December 5, 2017
Results First Posted
October 6, 2015
Record last verified: 2017-10