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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00138203
Recruitment Status : Completed
First Posted : August 30, 2005
Results First Posted : May 21, 2014
Last Update Posted : January 30, 2018
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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

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
No text entered.

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

Participant Flow:   Overall Study

  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.
No text entered.

Reporting Groups
SAHA Suberoylanilide Hydroxamic Acid (SAHA)

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      12  75.0% 
>=65 years      4  25.0% 
[Units: Years]
Mean (Standard Deviation)
 59.5  (16) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      13  81.3% 
Male      3  18.8% 
Region of Enrollment 
[Units: Participants]
United States   16 

  Outcome Measures

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 ]

  Serious Adverse Events

  Other Adverse Events

  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
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  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: Dr. Anne Traynor
Organization: University of Wisconsin Carbone Cancer Center
phone: (608) 262-8158

Responsible Party: National Cancer Institute (NCI) Identifier: NCT00138203     History of Changes
Other Study ID Numbers: NCI-2012-03070
NCI-2012-03070 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CO 04510 ( Other Identifier: University of Wisconsin Hospital and Clinics )
6860 ( Other Identifier: CTEP )
P30CA014520 ( U.S. NIH Grant/Contract )
U01CA062491 ( U.S. NIH Grant/Contract )
First Submitted: August 29, 2005
First Posted: August 30, 2005
Results First Submitted: February 13, 2013
Results First Posted: May 21, 2014
Last Update Posted: January 30, 2018