Vorinostat in Treating Patients With Progressive Metastatic Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00330161
First received: May 25, 2006
Last updated: April 25, 2014
Last verified: December 2012
Results First Received: April 25, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Prostate Cancer
Stage IV Prostate 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
Participants were recruited at 5 medical centers between May 2006 and February 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
  Description
Treatment (Vorinostat)

Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.

Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels.


Participant Flow:   Overall Study
    Treatment (Vorinostat)  
STARTED     29  
COMPLETED     29  
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.
Of the 29 patients enrolled, only 27 were analyzed. Two patients were deemed ineligible after treatment started and they were excluded from all analysis except adverse event collection.

Reporting Groups
  Description
Treatment (Vorinostat)

Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.

Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels.


Baseline Measures
    Treatment (Vorinostat)  
Number of Participants  
[units: participants]
  27  
Age  
[units: years]
Median ( Full Range )
 
Age     68  
  ( 54 to 80 )  
Gender  
[units: participants]
 
Female     0  
Male     27  
Region of Enrollment  
[units: participants]
 
United States     27  



  Outcome Measures
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1.  Primary:   Proportion of Patients Who do Not Demonstrate Disease Progression   [ Time Frame: At 6 months ]

2.  Secondary:   Incidence of Toxicity   [ Time Frame: Up to 3 years ]

3.  Secondary:   Rate of PSA Decline   [ Time Frame: Up to 3 years ]

4.  Secondary:   Progression-free Survival   [ Time Frame: From the start of treatment to time of progression, assessed up to 3 years ]

5.  Secondary:   Median Survival   [ Time Frame: Up to 3 years ]

6.  Secondary:   Objective Response Rate   [ Time Frame: Up to 3 years ]


  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
The primary objective was to determine the number of patients wtih progression-free survival at 6 months. Unfortunately all eligible patients were off therapy before the 6 month time point.


  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: Erin Sargent
Organization: University of Michigan Comprehensive Cancer Center
phone: (734) 936-3348
e-mail: esargent@umich.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00330161     History of Changes
Other Study ID Numbers: NCI-2012-03067, NCI-2012-03067, UMCC 2005.127, 6862, N01CM62206, N01CM62201, U01CA062491, P30CA046592
Study First Received: May 25, 2006
Results First Received: April 25, 2014
Last Updated: April 25, 2014
Health Authority: United States: Food and Drug Administration