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Paclitaxel, Carboplatin and Vorinostat for the Treatment of Advanced Stage Ovarian Carcinoma

This study has been terminated.
(toxicities)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00976183
First Posted: September 14, 2009
Last Update Posted: April 10, 2017
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.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Gynecologic Oncology Associates
Results First Submitted: August 9, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Ovarian Neoplasms
Intervention: Drug: Vorinostat

  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
The recruitment was from one location a private practice. The enrollment started on 01/15/2010. The recruitment was to be a two year time period.

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
Vorinostat

All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin.

Vorinostat: Vorinostat will start at 200 mg QD on weeks 1 and 3, and escalating to 300 mg QD after safety has been evaluated following 2 cycles of treatment. If safety is acceptable, then the following patients could be treated at 400 mg QD on weeks 1 and 3.

Vorinostat: Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD.


Participant Flow:   Overall Study
    Vorinostat
STARTED   18 
COMPLETED   18 [1] 
NOT COMPLETED   0 
[1] The study was closed on 05/30/12 due to adverse events. We did not complete enrollment



  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
Vorinostat

All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin.

Vorinostat: Vorinostat will start at 200 mg QD on weeks 1 and 3, and escalating to 300 mg QD after safety has been evaluated following 2 cycles of treatment. If safety is acceptable, then the following patients could be treated at 400 mg QD on weeks 1 and 3.

Vorinostat: Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD.


Baseline Measures
   Vorinostat 
Overall Participants Analyzed 
[Units: Participants]
 18 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      9  50.0% 
>=65 years      9  50.0% 
Age 
[Units: Years]
Median (Full Range)
 58 
 (41 to 74) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      18 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   18 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Objective Response Rate   [ Time Frame: 2 years or 24 months ]

2.  Secondary:   Number of Participants With Progression Free Survival (PFS) up to 24 Months   [ Time Frame: 2 years or 24 months ]


  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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: John P. Micha, M.D.
Organization: Gynecologic Oncology Associates
phone: 949-642-5165
e-mail: Research@gynoncology.com



Responsible Party: Gynecologic Oncology Associates
ClinicalTrials.gov Identifier: NCT00976183     History of Changes
Other Study ID Numbers: GOA-TCOV
First Submitted: September 10, 2009
First Posted: September 14, 2009
Results First Submitted: August 9, 2016
Results First Posted: April 10, 2017
Last Update Posted: April 10, 2017