Paclitaxel, Carboplatin and Vorinostat for the Treatment of Advanced Stage Ovarian Carcinoma
Since the mortality rates for patients with advanced ovarian carinoma are high, the most likely way to improve progression free and overall survival is with maximal "upfront" therapy (Morrow & Curtin, 1998). Currently, no triplet regimen has demonstrated compelling superiority. Therefore, the combination of Paclitaxel, Carboplatin, and Vorinostat is intriguing because of their potential synergy, distinct mechanisms of action, and non-overlapping toxicity.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Objective Response Rate [ Time Frame: 2 years or 24 months ] [ Designated as safety issue: Yes ]
- Progression Free Survival [ Time Frame: 2 years or 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Study Completion Date:||October 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
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)
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|United States, California|
|Gynecologic Oncology Associates|
|Newport Beach, California, United States, 92663|
|Principal Investigator:||John Micha, MD||Gynecologic Oncology Associates|