Vorinostat, Carboplatin and Gemcitabine in Women With Recurrent, Platinum-Sensitive Ovarian Cancer
Status:
Terminated
Trial end date:
2015-10-01
Target enrollment:
Participant gender:
Summary
This trial is a Phase Ib/II study of carboplatin/gemcitabine/vorinostat for the treatment of
platinum sensitive recurrent ovarian cancer. The carboplatin and gemcitabine combination is
an FDA approved regimen for platinum-sensitive recurrent ovarian cancer. Vorinostat is a type
of drug called a histone deacetylase inhibitor (HDAC inhibitor). HDAC inhibitors interact
with chromosomes in the cancer cell and cause cancer cells to stop growing. Vorinostat has
shown a decrease in the amount of ovarian cancer cells growing in the laboratory and also may
enhance the anti-cancer effects of carboplatin.The purpose of the Phase Ib study is to
determine the highest dose of the drug vorinostat that can be given safely in combination
with carboplatin and gemcitabine. Not everyone who participates in this research study will
receive the same dose of the study drug, vorinostat, but carboplatin and gemcitabine doses
are held constant. Vorinostat doses depend on previous enrollment and tolerability. The
expansion Phase II study uses the vorinostat dose found in the Phase Ib study in combination
with carboplatin/gemcitabine and as a single agent maintenance therapy to better understand
toxicity and efficacy.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborators:
Brigham and Women's Hospital Massachusetts General Hospital Merck Sharp & Dohme Corp.