A Phase 2 interventional study of Laboratory Biomarker Analysis and Pioglitazone Hydrochloride in Stage IA Non-Small Cell Lung Carcinoma, Stage IB Non-Small Cell Lung Carcinoma and Stage IIA Non-Small Cell Lung Carcinoma, sponsored by National Cancer Institute (NCI). Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-05.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
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.
PRIMARY OBJECTIVES:
I. To evaluate the mechanism(s) of action of pioglitazone as a candidate chemopreventive agent for lung cancer by investigating the effects on Ki-67 defined in non-small cell lung cancer (NSCLC) tumor tissue.
SECONDARY OBJECTIVES:
I. To determine the effects of pioglitazone on multiple markers listed below:
III. To analyze the expression of serum markers that are affected by pioglitazone.
IV. To describe the effects of limited treatment with pioglitazone on tumor metabolic activity as determined by FDG-PET (assessed before and after a minimum of 2 weeks of treatment).
OUTLINE:
Patients receive pioglitazone hydrochloride orally (PO) once daily (QD) for 14-42 days. Patients then undergo surgery.
6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.
This study's enrollment of 6 is below the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →National Cancer Institute (NCI) is the lead sponsor of 3,554 studies on the registry; 334 are open to participants now.
Of its 407 completed or terminated interventional studies of FDA-regulated products, 370 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Ability and willingness to undergo two bronchoscopies (before treatment and at the time of surgery)
Exclusion Criteria:
Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
Other: Laboratory Biomarker Analysis · Drug: Pioglitazone Hydrochloride · Other: Quality-of-Life Assessment
Correlative studies
Given PO
Also known as: Actos, Pioglitazone.HCl
Ancillary studies
Also known as: Quality of Life Assessment
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.
Time frame: Baseline and at the time of surgery, after 42 days of treatment
Change in Apoptosis Assessment (e.g., Caspase-3)
Changes in the expression levels (or grades) from baseline (prior to intervention) to post-intervention (resected tumor sample) will be plotted graphically as well as formally assessed using the McNemar's tests (for categorical variables) or Wilcoxon signed rank tests (for continuous variables) respectively.
Time frame: Baseline and at the time of surgery, after 42 days of treatment
Change in Levels of Serum CA-153
Each participant's pre- and post serum levels of CA-153 will be graphically represented and the mean levels analyzed using a paired t-test or Wilcoxon signed rank test, if the assumptions of the t-test are not met.
Time frame: Baseline and at the time of surgery, after 42 days of treatment
Change in Levels of Serum CRP
Each participant's pre- and post serum levels of CRP will be graphically represented and the mean levels analyzed using a paired t-test or Wilcoxon signed rank test, if the assumptions of the t-test are not met.
Time frame: Baseline and at the time of surgery, after 42 days of treatment
Gene Expression Analysis of RNA From Bronchial Brush Cells
For the gene expression profiles obtained from the data from normal bronchial brush cells, each participant's pre- and post gene expression will be graphically represented and the mean expression levels analyzed using a paired t-test or Wilcoxon signed rank test, if the assumptions of the t-test are not met.
Time frame: 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
To evaluate the adverse events profile, the maximum grade for each type of adverse event will be recorded for each participant and frequency tables will be reviewed to determine the overall patterns. The number and severity of adverse events (both regardless of attribution as well as those that are at least possibly, probably, or definitely related) will be tabulated and summarized.
Time frame: Up to the time of surgery, after 42 days of treatment
Number of Participants With Clinical Response, Based on Response Evaluation Criteria in Solid Tumors ( RECIST) Version 1.1
Clinical response rates will be summarized. Complete response (CR) is the disappearance of all non-nodal target lesions (TL) and each target lymph node (LN) must have reduction in short axis to \<1.0cm. Partial Response (PR) is at least a 30% decrease in the sum of the longest diameters (LD) of the non-nodal TR and the short axis of the target LN with the baseline sum diameters (BSD) as reference. Progression (PD) is at least 1 new malignant lesion or LN whose short axis increased to \>1.5 cm or at least a 20% increase in the sum of TL diameters with the minimum sum of diameters as reference.
Time frame: Up to the time of surgery, after 42 days of treatment
Number of Participants With Complete Pathologic Response
Complete pathologic response was defined as no viable residual tumor cells. Acellular residual mucin pools also considered a pathologic complete response.
Time frame: Up to the time of surgery, after 42 days of treatment
Percent Change in Cyclin D1
Changes in the expression levels from baseline (prior to intervention) to post intervention (resected tumor sample) will be plotted graphically.
Time frame: Baseline to the time of surgery, after 42 days of treatment
Percent Change in MUC1
Changes in the expression levels from baseline (prior to intervention) to post intervention (resected tumor sample) will be plotted graphically.
Time frame: Baseline to the time of surgery, after 42 days of treatment
Percent Change in p21
Changes in the expression levels from baseline (prior to intervention) to post intervention (resected tumor sample) will be plotted graphically.
Time frame: Baseline to the time of surgery, after 42 days of treatment
Percent Change in PPARy
Changes in the expression levels from baseline (prior to intervention) to post intervention (resected tumor sample) will be plotted graphically.
Time frame: Baseline to the time of surgery, after 42 days of treatment
Percent Change in SUVmax From the PET Scan
The percent change from pre to post-intervention in SUV max values will be summarized using descriptive statistics and simple graphical plots.
Time frame: Baseline to the time of surgery, after 42 days of treatment
Pre-intervention SUV of PET Scan
The pre- and post-intervention SUV will be summarized using descriptive statistics and simple graphical plots.
Time frame: Baseline
Post-intervention SUV of PET Scan
The pre- and post-intervention SUV will be summarized using descriptive statistics and simple graphical plots.
Time frame: Time of surgery, after 42 days of treatment
Ten subjects were pre-registered at one Cancer Prevention Network (CPN) member organization from 2011 to 2013.
| Milestone | Treatment (Pioglitazone Hydrochloride) |
|---|---|
| Started | 6 |
| Completed | 6 |
| Not completed | 0 |
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.
| Percent change in Ki-67 measurements | Treatment (Pioglitazone Hydrochloride) |
|---|---|
| Percent Change in Ki-67 by Immunohistochemistry (IHC) | -20.0 (-40.0 to -11.1) |
Changes in the expression levels (or grades) from baseline (prior to intervention) to post-intervention (resected tumor sample) will be plotted graphically as well as formally assessed using the McNemar's tests (for categorical variables) or Wilcoxon signed rank tests (for continuous variables) respectively.
No measurements were reported for this outcome.
Each participant's pre- and post serum levels of CA-153 will be graphically represented and the mean levels analyzed using a paired t-test or Wilcoxon signed rank test, if the assumptions of the t-test are not met.
No measurements were reported for this outcome.
Each participant's pre- and post serum levels of CRP will be graphically represented and the mean levels analyzed using a paired t-test or Wilcoxon signed rank test, if the assumptions of the t-test are not met.
No measurements were reported for this outcome.
For the gene expression profiles obtained from the data from normal bronchial brush cells, each participant's pre- and post gene expression will be graphically represented and the mean expression levels analyzed using a paired t-test or Wilcoxon signed rank test, if the assumptions of the t-test are not met.
No measurements were reported for this outcome.
To evaluate the adverse events profile, the maximum grade for each type of adverse event will be recorded for each participant and frequency tables will be reviewed to determine the overall patterns. The number and severity of adverse events (both regardless of attribution as well as those that are at least possibly, probably, or definitely related) will be tabulated and summarized.
| participants | Treatment (Pioglitazone Hydrochloride) |
|---|---|
| No Adverse Events | 3 |
| Grade 1 Adverse Events | 2 |
Clinical response rates will be summarized. Complete response (CR) is the disappearance of all non-nodal target lesions (TL) and each target lymph node (LN) must have reduction in short axis to \<1.0cm. Partial Response (PR) is at least a 30% decrease in the sum of the longest diameters (LD) of the non-nodal TR and the short axis of the target LN with the baseline sum diameters (BSD) as reference. Progression (PD) is at least 1 new malignant lesion or LN whose short axis increased to \>1.5 cm or at least a 20% increase in the sum of TL diameters with the minimum sum of diameters as reference.
No measurements were reported for this outcome.
Complete pathologic response was defined as no viable residual tumor cells. Acellular residual mucin pools also considered a pathologic complete response.
| participants | Treatment (Pioglitazone Hydrochloride) |
|---|---|
| Complete Response | 1 |
| No Response | 5 |
Changes in the expression levels from baseline (prior to intervention) to post intervention (resected tumor sample) will be plotted graphically.
| Percent change in Cyclin D1 measurements | Treatment (Pioglitazone Hydrochloride) |
|---|---|
| Percent Change in Cyclin D1 | -69 (-91 to 50) |
Changes in the expression levels from baseline (prior to intervention) to post intervention (resected tumor sample) will be plotted graphically.
| Percent change in MUC1 measurements | Treatment (Pioglitazone Hydrochloride) |
|---|---|
| Percent Change in MUC1 | 0 (-16.7 to 40) |
Changes in the expression levels from baseline (prior to intervention) to post intervention (resected tumor sample) will be plotted graphically.
| Percent change in p21 measurements | Treatment (Pioglitazone Hydrochloride) |
|---|---|
| Percent Change in p21 | -5 (-88.9 to 50) |
Changes in the expression levels from baseline (prior to intervention) to post intervention (resected tumor sample) will be plotted graphically.
| Percent change in PPARy measurements | Treatment (Pioglitazone Hydrochloride) |
|---|---|
| Percent Change in PPARy | 183.4 (0 to 1100) |
The percent change from pre to post-intervention in SUV max values will be summarized using descriptive statistics and simple graphical plots.
| Percent change in tumor SUV max values | Treatment (Pioglitazone Hydrochloride) |
|---|---|
| Percent Change in SUVmax From the PET Scan | 0 (-15.4 to 0) |
The pre- and post-intervention SUV will be summarized using descriptive statistics and simple graphical plots.
| SUV | Treatment (Pioglitazone Hydrochloride) |
|---|---|
| Pre-intervention SUV of PET Scan | 13.0 (12.2 to 18.7) |
The pre- and post-intervention SUV will be summarized using descriptive statistics and simple graphical plots.
| SUV | Treatment (Pioglitazone Hydrochloride) |
|---|---|
| Post-intervention SUV of PET Scan | 12.2 (11.0 to 18.7) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Pioglitazone Hydrochloride) | — | 0/5 (0%) | 2/5 (40%) |
| Event | Treatment (Pioglitazone Hydrochloride) |
|---|---|
| Oral PainGastrointestinal disorders | 1/5 |
| TremorNervous system disorders | 1/5 |
| Hemorrhoidal HemorrhageGastrointestinal disorders | 1/5 |
| Lung InfectionInfections and infestations | 1/5 |
Participants who met eligibility criteria that were registered and received study agent.
| Age, Continuous(years) | Treatment (Pioglitazone Hydrochloride) |
|---|---|
| Median | 64 (54 to 72) |
| Sex: Female, Male(Participants) | Treatment (Pioglitazone Hydrochloride) |
|---|---|
| Female | 1 |
| Male | 5 |
| Region of Enrollment(participants) | Treatment (Pioglitazone Hydrochloride) |
|---|---|
| United States | 6 |
| Baseline Eastern Cooperative Oncology Group (ECOG) performance status(participants) | Treatment (Pioglitazone Hydrochloride) |
|---|---|
| 0=Asymptomatic and fully active | 5 |
| 1=Symptomatic and fully ambulatory | 1 |
| Smoking Status(participants) | Treatment (Pioglitazone Hydrochloride) |
|---|---|
| Former | 4 |
| Current | 2 |
The record gives a start of Apr 2011, a primary completion of Dec 2012 and a completion of Feb 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2015, 2 years 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Pioglitazone
Carcinoma, Non-Small-Cell Lung →
National Cancer Institute (NCI) →