Suberoylanilide Hydroxamic Acid in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00138203
First received: August 29, 2005
Last updated: April 25, 2014
Last verified: December 2012
Results First Received: February 13, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Interventions: Drug: vorinostat
Other: laboratory biomarker analysis

  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
Recruitment will occur at all participating sites from August 2005 - June 2007.

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

Reporting Groups
  Description
SAHA Suberoylanilide Hydroxamic Acid (SAHA), 400mg orally, once daily, in a 21 day cycle.

Participant Flow:   Overall Study
    SAHA  
STARTED     16  
COMPLETED     16  
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
SAHA Suberoylanilide Hydroxamic Acid (SAHA)

Baseline Measures
    SAHA  
Number of Participants  
[units: participants]
  16  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     12  
>=65 years     4  
Age  
[units: years]
Mean ± Standard Deviation
  59.5  ± 16  
Gender  
[units: participants]
 
Female     13  
Male     3  
Region of Enrollment  
[units: participants]
 
United States     16  



  Outcome Measures
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1.  Primary:   Response Per RECIST Criteria   [ Time Frame: Time from treatment initiation until the end of treatment. The median number of cycles was 3 (range 1-27) ]

2.  Secondary:   Time to Progression   [ Time Frame: From start of treatment to progression (average was 3.7 months) ]

3.  Secondary:   Overall Survial   [ Time Frame: From treatment start to time of death ]

4.  Secondary:   Toxicity   [ Time Frame: From first dose of treatment until 30 days from the last dose of treatment ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Dr. Anne Traynor
Organization: University of Wisconsin Carbone Cancer Center
phone: (608) 262-8158
e-mail: amt@medicine.wisc.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00138203     History of Changes
Other Study ID Numbers: NCI-2012-03070, NCI-2012-03070, CO 04510, 6860, P30CA014520, U01CA062491
Study First Received: August 29, 2005
Results First Received: February 13, 2013
Last Updated: April 25, 2014
Health Authority: United States: Food and Drug Administration