Vorinostat in Treating Patients With Locally Recurrent or Metastatic Cancer of the Urothelium

This study has been terminated.
(Trial stopped early for futility)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00363883
First received: August 10, 2006
Last updated: January 28, 2015
Last verified: January 2014
Results First Received: January 28, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Localized Transitional Cell Cancer of the Renal Pelvis and Ureter
Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter
Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter
Regional Transitional Cell Cancer of the Renal Pelvis and Ureter
Transitional Cell Carcinoma of the Bladder
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
No text entered.

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) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

vorinostat: Given orally

laboratory biomarker analysis: Correlative studies


Participant Flow:   Overall Study
    Treatment (Vorinostat)  
STARTED     14  
COMPLETED     14  
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
Treatment (Vorinostat)

Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

vorinostat: Given orally

laboratory biomarker analysis: Correlative studies


Baseline Measures
    Treatment (Vorinostat)  
Number of Participants  
[units: participants]
  14  
Age  
[units: years]
Median ( Full Range )
  65  
  ( 43 to 84 )  
Gender  
[units: participants]
 
Female     2  
Male     12  
Region of Enrollment  
[units: participants]
 
United States     14  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Objective Tumor Response Rate   [ Time Frame: Response assessed after every 2 cycles (6 weeks) up to 26 weeks ]

2.  Secondary:   Overall Survival   [ Time Frame: Up to 26 weeks ]

3.  Secondary:   Progression-free Survial   [ Time Frame: assessed up to 26 weeks ]


  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
Study was terminated early after the first stage of a two-stage design, allowing for early termination for discouraging results.


  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: DCC Project Administrator
Organization: California Cancer Consortium
phone: 626-256-4673 ext 60094
e-mail: CCCP@coh.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00363883     History of Changes
Other Study ID Numbers: NCI-2012-02844, NCI-2012-02844, PHII-61, 6879, N01CM62209, P30CA033572
Study First Received: August 10, 2006
Results First Received: January 28, 2015
Last Updated: January 28, 2015
Health Authority: United States: Food and Drug Administration