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

NCT00976183 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2017-04-10

Study results available
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Summary

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.

Conditions

  • Ovarian Neoplasms

Interventions

DRUG

Vorinostat

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.

DRUG

Vorinostat

Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD.

Sponsors & Collaborators

Principal Investigators

  • John Micha, MD · Gynecologic Oncology Associates

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2012-06-30
Completion
2012-10-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00976183 on ClinicalTrials.gov