Phase IB/II Study of Combination Vorinostat, Carboplatin and Gemcitabine + Vorinostat Maintenance in Women With Recurrent, Platinum-Sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
- The investigators are looking for the highest dose of the study drug that can be
administered safely without severe or unmanageable side effects. Not everyone who
participates in this research study will receive the same dose of the study drug,
vorinostat. The dose you get will depend on the number of participants who have been
enrolled in the study before you and how well they have tolerated their doses. There
are 3 dose levels for vorinostat that are being tested.
- Each treatment cycle lasts three weeks or 21 days. The carboplatin and gemcitabine
chemotherapy will be administered as per the FDA approved doses. The carboplatin will
be administered on day 1 through the vein and gemcitabine will be administered
intravenously on day 1 and day 8. Participants will receive up to 8 cycles of
chemotherapy, as determined by the participant and their doctor, depending on how well
the cancer is responding and what side effects the participant is experiencing.
- Participants will take the study medication, vorinostat, by mouth, once a day in the
morning beginning on day 1 of the cycle. Participants will take the vorinostat for the
first two weeks (14 days) of each cycle. The 3rd week of the cycle, participants will
not take the study drug vorinostat.
- Physical exams will be performed regularly while participants are on this study.
- Participants cancer will be assessed during treatment while on this study. If
participants CA125 value is elevated, the investigators will follow the cancer by the
CA125 blood test every 2 cycles. If the cancer is only visible on CT or MRI scan and
the CA125 blood test is not elevated, regular assessment of the cancer (every 2 cycles
of chemotherapy) by CT or MRI scan will also occur. Once the chemotherapy has been
completed, a CT or MRI scan will be performed on all participants to determine if they
are eligible to continue on the study and receive vorinostat maintenance.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the maximally tolerated dose (MTD) of vorinostat when combined with fixed dose, standard carboplatin/gemcitabine in patients wtih recurrent platinum-sensitive epithelial ovarian cancer.
Ursula A. Matulonis, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|