Paclitaxel, Carboplatin and Vorinostat for the Treatment of Advanced Stage Ovarian Carcinoma
Part of paid clinical trials in Newport Beach, California.
- Sponsor
- Gynecologic Oncology Associates
- Study ID
- NCT00976183
- Phase
- PHASE1/PHASE2
- Status
- Terminated
Conditions
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Vorinostat — DRUGVorinostat 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 — DRUGVorinostat will be given as a lead-in dose escalation starting at 200 mg QD.
Study Details
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.
Key Dates
- Start date
- Oct 31, 2009
- Status verified
- Aug 2016
- Primary completion
- Jun 30, 2012
- Completion
- Oct 31, 2012
Study Design
- Enrollment
- 18 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: VorinostatAll study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin.
Primary Outcome Measure
Objective Response Rate [ Time Frame: 2 years or 24 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Gynecologic Oncology Associates | Newport Beach | California | 92663 | - |
Find similar trials in Newport Beach, CA
By condition
By specialty
By research site
Related Studies
- A Study of Sigvotatug Vedotin in Advanced Solid TumorsPHASE1 · Recruiting · Seagen, a wholly owned subsidiary of Pfizer · Anchorage, Alaska
- A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib StudyPHASE2 · Recruiting · GlaxoSmithKline · Tucson, Arizona
- Developing a Test of Uterine Lavage for the Detection of Ovarian CancerRecruiting · Massachusetts General Hospital · Little Rock, Arkansas
- A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid TumorsPHASE1/PHASE2 · Recruiting · Bristol-Myers Squibb · Clovis, California