ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00976183
Recruitment Status : Terminated (toxicities)
First Posted : September 14, 2009
Results First Posted : April 10, 2017
Last Update Posted : April 10, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Gynecologic Oncology Associates

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ovarian Neoplasms
Intervention Drug: Vorinostat
Enrollment 18

Recruitment Details 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  
Arm/Group Title Vorinostat
Hide Arm/Group Description

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.

Period Title: Overall Study
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
Arm/Group Title Vorinostat
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<=18 years
0
   0.0%
Between 18 and 65 years
9
  50.0%
>=65 years
9
  50.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 18 participants
58
(41 to 74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
18
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
1.Primary Outcome
Title Objective Response Rate
Hide Description Clinical response was assessed by clinical, serologic, and radiographic means.
Time Frame 2 years or 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Response Evaluation Criteria In Solid Tumors (RECIST v1.0)
Arm/Group Title Vorinostat
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: participants
12
2.Secondary Outcome
Title Number of Participants With Progression Free Survival (PFS) up to 24 Months
Hide Description Progression-free survival was defined as the length of time from the date of initial induction chemotherapy until clinical, radiological, or CA-125 progression
Time Frame 2 years or 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vorinostat
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: participants
18
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vorinostat
Hide Arm/Group Description

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.

All-Cause Mortality
Vorinostat
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Vorinostat
Affected / at Risk (%) # Events
Total   3/18 (16.67%)    
Gastrointestinal disorders   
gastrointestinal event   3/18 (16.67%)  3
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Vorinostat
Affected / at Risk (%) # Events
Total   5/18 (27.78%)    
Blood and lymphatic system disorders   
Thrombocytopenia   1/18 (5.56%)  1
Neutropenia   2/18 (11.11%)  2
Gastrointestinal disorders   
Diarrhea   1/18 (5.56%)  1
Nervous system disorders   
Neuropathy   1/18 (5.56%)  1
Indicates events were collected by systematic assessment
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
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