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

NCT00976183TerminatedPHASE1, PHASE2INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Gynecologic Oncology Associates

Enrollment

18

Start Date

2009-10-01

Completion Date

2012-06-01

Study Type

INTERVENTIONAL

Official Title

A Phase I/II, Open-Label, Non-Randomized, Pilot Study of Weekly Paclitaxel, Every Four-week Carboplatin and Oral Vorinostat for Patients Newly Diagnosed With Stage III/IV Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer

Interventions

VorinostatVorinostat

Conditions

Ovarian Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* Subjects with a histologic or cytologic diagnosis of stage III/IV ovarian cancer, fallopian tube epithelial cancer, or peritoneal cancer who have not received prior chemotherapy or radiotherapy.
* Subjects must have the appropriate surgery for their gynecologic cancer. However, subjects may be treated in a neoadjuvant manner, with surgery being performed after chemotherapy cycles 1, 2, or 3.
* If neoadjuvant therapy is not administered, subjects must receive their first dose no more than six weeks postoperatively.
* Subjects must have adequate bone marrow, renal and hepatic function as defined by WBC \> 3,000 cells/cu ml., platelets \> 100,000/cu.ml., calculated creatinine clearance \> 50 ccs/min., bilirubin \< 1.5 mg/dl, and SGOT \< three times normal.
* Karnofsky performance status \> 50%.
* Subjects who have signed an institutional review board (IRB) approved informed consent form.

Exclusion Criteria:

* Subjects with epithelial ovarian cancer of low malignancy potential.
* Subjects with septicemia, severe infection, or acute hepatitis.
* Subjects with a history of congestive heart failure, angina, or a history of myocardial infarction within the past six months.

Outcome Measures

Primary Outcomes

Objective Response Rate

Clinical response was assessed by clinical, serologic, and radiographic means.

Time frame: 2 years or 24 months

Secondary Outcomes

Number of Participants With Progression Free Survival (PFS) up to 24 Months

Progression-free survival was defined as the length of time from the date of initial induction chemotherapy until clinical, radiological, or CA-125 progression

Time frame: 2 years or 24 months

Locations

Gynecologic Oncology Associates, Newport Beach, United States

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