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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

Phase 1/Phase 2
18 Years
Not Enrolling
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Thank you

Trial Information

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.

Inclusion Criteria:

- Histologically confirmed recurrent epithelial ovarian cancer, fallopian tube cancer,
or peritoneal cancer

- Must have received a platinum-based chemotherapy regimen at initial diagnosis

- Patients with primary platinum-sensitive (defined as a cancer initially
platinum-sensitive followed by a progression-free interval from first exposure to
platinum of 6 months or greater) recurrent ovarian, tubal or peritoneal cancer

- Must have an elevated CA125 (twice the ULN) within 2 weeks of enrolling on study (2
pretreatment measurements that are twice the upper limits of institutional normal and
are drawn at least 1 day but not more than 14 days apart). At least one of the
samples should be checked within one week of starting treatment. Measurable cancer
via RECIST criteria via CT or MRI scan is not required but if clinically indicated
will be monitored.

- For patients who do not have an elevated CA125 (twice the ULN), participants must
have measurable disease, defined as at least one lesion that can be accurately
measured in at least one dimension (longest diameter to be recorded) as 20mm or
greater with conventional techniques or as 10mm or greater with spiral CT scan.

- 18 years of age or older

- Life expectancy of greater than 16 weeks

- ECOG Performance Status 0, 1, or 2

- Participants must have normal organ and marrow function as outlined in the protocol

- Patients could have received up to 1 prior non-platinum chemotherapy regimen in the
recurrent setting (anti-angiogenic agents and other phase II non-hormonal therapies
used to treat recurrent cancer count as a prior non-platinum therapy) but only one
prior platinum (used to treat initial diagnosis). Patients may received up to 2
prior hormonal therapies.

- Women of child-bearing potential must agree to use adequate contraception prior to
study entry and for the duration of study participation

- Must be able and willing to take oral medications

- No clinical nor radiographic evidence of an existing or impending bowel obstruction

- Should be at least 2 weeks from any surgical procedure, with the exception of minor
surgery, such as port placement

- Patients who have known carboplatin hypersensitivity reaction can receive carboplatin
if they are followed by an allergist, follow a published hypersensitivity
desensitization protocol when receiving carboplatin, and agree to receive carboplatin
under these circumstances

- Patients taking valproic acid for epilepsy may enroll if they discontinue valproic
acid 30 days prior to enrolling for washout

- Patients must have a normal QTc interval and no history of QTc prolongation on EKG

Exclusion Criteria:

- Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C)
prior to entering the study or those who have not recovered from adverse events due
to agents administered more than 4 weeks earlier

- May not be receiving any other investigational agent

- Participants with known brain metastases should be excluded from this clinical trial

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to vorinostat

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, pulmonary disease, symptomatic congestive heart failure, unstable angina
pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would
limit compliance with study requirements

- Pregnant or breastfeeding women

- Individuals with a history of different malignancy are ineligible except for the
following circumstances: disease-free for at least 5 years and are deemed by the
investigator to be a low risk for recurrence of that malignancy; cervical cancer in
situ, concurrent stage IA and grade I endometrial cancer, and basal cell or squamous
cell carcinoma of the skin

- Patients taking valproic acid unless valproic acid is stopped at least 30 days prior
to enrollment

- Receipt in the past of any other HDAC inhibitor for treatment of any malignancy

- Receipt of radiation therapy to >25% of bone marrow-bearing areas

- Patients who have gastrointestinal disorders likely to interfere with absorption of

- Known active HIV or hepatitis viral infection

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Ursula A. Matulonis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

June 2009

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Cancer
  • carboplatin
  • gemcitabine
  • vorinostat
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms



Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617