Pioglitazone Hydrochloride in Treating Patients With Stage IA-IIIA Non-small Cell Lung Cancer

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01342770
First received: April 23, 2011
Last updated: December 21, 2015
Last verified: February 2013
Results First Received: September 4, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: 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
Interventions: Other: Laboratory Biomarker Analysis
Drug: Pioglitazone Hydrochloride
Other: Quality-of-Life Assessment

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Ten subjects were pre-registered at one Cancer Prevention Network (CPN) member organization from 2011 to 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Treatment (Pioglitazone Hydrochloride) Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.

Participant Flow:   Overall Study
    Treatment (Pioglitazone Hydrochloride)  
STARTED     6  
COMPLETED     6  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who met eligibility criteria that were registered and received study agent.

Reporting Groups
  Description
Treatment (Pioglitazone Hydrochloride) Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.

Baseline Measures
    Treatment (Pioglitazone Hydrochloride)  
Number of Participants  
[units: participants]
  6  
Age  
[units: years]
Median (Full Range)
  64   (54 to 72)  
Gender  
[units: participants]
 
Female     1  
Male     5  
Region of Enrollment  
[units: participants]
 
United States     6  
Baseline Eastern Cooperative Oncology Group (ECOG) performance status  
[units: participants]
 
0=Asymptomatic and fully active     5  
1=Symptomatic and fully ambulatory     1  
Somoking Status  
[units: participants]
 
Former     4  
Current     2  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Change in Ki-67 by Immunohistochemistry (IHC)   [ Time Frame: Baseline to the time of surgery ]

2.  Secondary:   Incidence of Adverse Events Graded According to Common Terminology Criteria for Adverse Events Version 4.0   [ Time Frame: Up to the time of surgery ]

3.  Secondary:   Number of Participants With Complete Pathologic Response   [ Time Frame: Up to the time of surgery ]

4.  Secondary:   Percent Change in Cyclin D1   [ Time Frame: Baseline to the time of surgery ]

5.  Secondary:   Percent Change in MUC1   [ Time Frame: Baseline to the time of surgery ]

6.  Secondary:   Percent Change in p21   [ Time Frame: Baseline to the time of surgery ]

7.  Secondary:   Percent Change in PPARy   [ Time Frame: Baseline to the time of surgery ]

8.  Secondary:   Percent Change in SUVmax From the PET Scan   [ Time Frame: Baseline to the time of surgery ]

9.  Secondary:   Pre-intervention SUV of PET Scan   [ Time Frame: Baseline ]

10.  Secondary:   Post-intervention SUV of PET Scan   [ Time Frame: Time of surgery ]

11.  Secondary:   Change in Apoptosis Assessment (e.g., Caspase-3)   [ Time Frame: Baseline to the time of surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

12.  Secondary:   Change in Levels of Serum CA-153   [ Time Frame: Baseline to the time of surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

13.  Secondary:   Change in Levels of Serum CRP   [ Time Frame: Baseline to the time of surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

14.  Secondary:   Gene Expression Analysis of RNA From Bronchial Brush Cells   [ Time Frame: Up to the time of surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

15.  Secondary:   Number of Participants With Clinical Response, Based on Response Evaluation Criteria in Solid Tumors ( RECIST) Version 1.1   [ Time Frame: Up to the time of surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dennis Wigle, M.D., Ph.D.
Organization: Mayo Clinic
phone: 507-284-2511
e-mail: wigle.dennis@mayo.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01342770     History of Changes
Other Study ID Numbers: NCI-2011-03826
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 ( US NIH Grant/Contract Award Number )
N01CN35000 ( US NIH Grant/Contract Award Number )
P30CA015083 ( US NIH Grant/Contract Award Number )
Study First Received: April 23, 2011
Results First Received: September 4, 2015
Last Updated: December 21, 2015
Health Authority: United States: Food and Drug Administration