Paclitaxel, Carboplatin and Vorinostat for the Treatment of Advanced Stage Ovarian Carcinoma
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|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
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Neoplasms||Drug: Vorinostat||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II, Open-Label, Non-Randomized, Pilot Study of Weekly Paclitaxel, Every Four-week Carboplatin and Oral Vorinostat for Patients Newly Diagnosed With Stage III/IV Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||October 2012|
U.S. FDA Resources
All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin.
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.
Other Name: suberoylanilide hydroxamic acid (SAHA)Drug: Vorinostat
Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD.
Other Name: suberoylanilide hydroxamic acid (SAHA)
- Objective Response Rate [ Time Frame: 2 years or 24 months ]Clinical response was assessed by clinical, serologic, and radiographic means.
- Number of Participants With Progression Free Survival (PFS) up to 24 Months [ Time Frame: 2 years or 24 months ]Progression-free survival was defined as the length of time from the date of initial induction chemotherapy until clinical, radiological, or CA-125 progression
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00976183
|United States, California|
|Gynecologic Oncology Associates|
|Newport Beach, California, United States, 92663|
|Principal Investigator:||John Micha, MD||Gynecologic Oncology Associates|