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