Pioglitazone to Treat Adults Undergoing Surgery for Non-small Cell Lung Cancer

This study has been terminated.
(Study never published; terminated early due to low accrual.)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00923949
First received: June 17, 2009
Last updated: February 14, 2012
Last verified: February 2012
Results First Received: January 11, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non-Small-Cell Lung Cancer
Intervention: Drug: Pioglitazone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
1 participant was accrued to this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pioglitazone 45 mg tablet daily by mouth for six weeks

Participant Flow:   Overall Study
    Pioglitazone  
STARTED     1  
COMPLETED     1  
NOT COMPLETED     0  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Pioglitazone 45 mg tablet daily by mouth for six weeks

Baseline Measures
    Pioglitazone  
Number of Participants  
[units: participants]
  1  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     0  
>=65 years     1  
Age  
[units: years]
Mean ± Standard Deviation
  74.5  ± 0  
Gender  
[units: participants]
 
Female     0  
Male     1  
Ethnicity (NIH/OMB)  
[units: Participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     1  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: Participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     1  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     1  



  Outcome Measures
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1.  Primary:   Number of Participants With a Change in Ki-67 Due to the Effect of Pioglitazone in Tumor Tissue   [ Time Frame: 58 days ]

2.  Secondary:   Number of Participants With Effects of Pioglitazone on Multiple Biomarkers in Tumor   [ Time Frame: 58 days ]

3.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 58 days ]

4.  Secondary:   Number of Participants With Metabolic Activity Determined by Fludeoxyglucose Positron-emission Tomography (FDG-PET)   [ Time Frame: 58 days ]

5.  Secondary:   Number of Participants With Effects of Pioglitazone on Premalignant Tissue Biomarkers   [ Time Frame: 58 days ]

6.  Secondary:   Number of Participants With Effects of Pioglitazone on Histologically Normal Tissue Biomarkers   [ Time Frame: 58 days ]

7.  Secondary:   Number of Participants With Effects of Pioglitazone on Serum Tumor Markers   [ Time Frame: 58 days ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
Study never published; terminated early due to low accrual.  


Results Point of Contact:  
Name/Title: Giuseppe Giaccone M.D.
Organization: National Cancer Institute
phone: 301-496-4916
e-mail: giacconeg@mail.nih.gov


Publications:

Responsible Party: Giuseppe Giaccone, M.D./National Cancer Institute, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00923949     History of Changes
Obsolete Identifiers: NCT00751725
Other Study ID Numbers: 080208, 08-C-0208
Study First Received: June 17, 2009
Results First Received: January 11, 2012
Last Updated: February 14, 2012
Health Authority: United States: Federal Government