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 — DRUG
    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 — DRUG
    Vorinostat 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: Vorinostat
    All 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)

FacilityCityStateZIPSite coordinators
Gynecologic Oncology AssociatesNewport BeachCalifornia92663-

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