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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-03826 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| MAYO-MAY10-15-02 | |||
| N01-CN-2012-00042 | |||
| CDR0000699459 | |||
| MAY10-15-02 | Other Identifier | Mayo Clinic | |
| MAY10-15-02 | Other Identifier | DCP | |
| N01CN00042 | U.S. NIH Grant/Contract | View source | |
| N01CN35000 | U.S. NIH Grant/Contract | View source | |
| P30CA015083 | U.S. NIH Grant/Contract | View source |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (pioglitazone hydrochloride) | Experimental | Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laboratory Biomarker Analysis | Other | Correlative studies |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and at the time of surgery, after 42 days of treatment |
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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)
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:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Limburg | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
Four participants were deemed screen failures (3 without histologically-confirmed non-small cell lung cancer (NSCLC) and 1 with metastatic NSCLC and were excluded from all analyses.
Ten subjects were pre-registered at one Cancer Prevention Network (CPN) member organization from 2011 to 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Pioglitazone Hydrochloride) | Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Pioglitazone Hydrochloride |
| Drug |
Given PO |
|
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| Quality-of-Life Assessment | Other | Ancillary studies |
|
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline |
| Post-intervention SUV of PET Scan | The pre- and post-intervention SUV will be summarized using descriptive statistics and simple graphical plots. | Time of surgery, after 42 days of treatment |
| COMPLETED |
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| NOT COMPLETED |
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Participants who met eligibility criteria that were registered and received study agent.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Pioglitazone Hydrochloride) | Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Baseline Eastern Cooperative Oncology Group (ECOG) performance status | Number | participants |
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| Smoking Status | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Includes all registered participants with pre- and post-intervention tumor tissue samples except one participant who was deemed ineligible post-registration | Posted | Median | Full Range | Percent change in Ki-67 measurements | Baseline and at the time of surgery, after 42 days of treatment |
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| Secondary | 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. | Data were not collected. Study team decision not to analyze this endpoint. | Posted | Baseline and at the time of surgery, after 42 days of treatment |
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| Secondary | 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. | Data were not collected due to a study team decision not to analyze this endpoint. | Posted | Baseline and at the time of surgery, after 42 days of treatment |
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| Secondary | 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. | Data not collected due to a study team decision not to analyze this endpoint. | Posted | Baseline and at the time of surgery, after 42 days of treatment |
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| Secondary | 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. | Data not collected due to a study team decision not to analyze this endpoint. | Posted | Up to the time of surgery, after 42 days of treatment |
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| Secondary | 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. | Includes all registered eligible participants | Posted | Number | participants | Up to the time of surgery, after 42 days of treatment |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Data not collected due to a study team decision not to analyze this endpoint. | Posted | Up to the time of surgery, after 42 days of treatment |
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| Secondary | 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. | Includes all registered participants | Posted | Number | participants | Up to the time of surgery, after 42 days of treatment |
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| Secondary | 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. | Includes all registered participants with pre- and post-intervention tumor tissue samples except one participant who was deemed ineligible post-registration | Posted | Median | Full Range | Percent change in Cyclin D1 measurements | Baseline to the time of surgery, after 42 days of treatment |
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| Secondary | Percent Change in MUC1 | Changes in the expression levels from baseline (prior to intervention) to post intervention (resected tumor sample) will be plotted graphically. | Includes all registered participants with pre- and post-intervention tumor tissue samples except one participant who was deemed ineligible post-registration | Posted | Median | Full Range | Percent change in MUC1 measurements | Baseline to the time of surgery, after 42 days of treatment |
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| Secondary | Percent Change in p21 | Changes in the expression levels from baseline (prior to intervention) to post intervention (resected tumor sample) will be plotted graphically. | Includes all registered participants with pre- and post-intervention tumor tissue samples except one participant who was deemed ineligible post-registration | Posted | Median | Full Range | Percent change in p21 measurements | Baseline to the time of surgery, after 42 days of treatment |
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| Secondary | Percent Change in PPARy | Changes in the expression levels from baseline (prior to intervention) to post intervention (resected tumor sample) will be plotted graphically. | Includes all registered participants with pre- and post-intervention tumor tissue samples except one participant who was deemed ineligible post-registration | Posted | Median | Full Range | Percent change in PPARy measurements | Baseline to the time of surgery, after 42 days of treatment |
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| Secondary | 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. | Includes registered eligible participants with pre- and post-intervention PET/CT images obtained | Posted | Median | Full Range | Percent change in tumor SUV max values | Baseline to the time of surgery, after 42 days of treatment |
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| Secondary | Pre-intervention SUV of PET Scan | The pre- and post-intervention SUV will be summarized using descriptive statistics and simple graphical plots. | Includes registered eligible participants with pre- and post-intervention PET/CT images obtained | Posted | Median | Full Range | SUV | Baseline |
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| Secondary | Post-intervention SUV of PET Scan | The pre- and post-intervention SUV will be summarized using descriptive statistics and simple graphical plots. | Includes registered eligible participants with pre- and post-intervention PET/CT images obtained | Posted | Median | Full Range | SUV | Time of surgery, after 42 days of treatment |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment (Pioglitazone Hydrochloride) | Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery. | 0 | 5 | 2 | 5 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oral Pain | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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| Hemorrhoidal Hemorrhage | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Lung Infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dennis Wigle, M.D., Ph.D. | Mayo Clinic | 507-284-2511 | wigle.dennis@mayo.edu |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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