Status:
TERMINATED
Paclitaxel, Carboplatin and Vorinostat for the Treatment of Advanced Stage Ovarian Carcinoma
Lead Sponsor:
Gynecologic Oncology Associates
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Ovarian Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
Ovarian cancer is the fifth most common cancer in women, accounting for nearly 15,280 deaths annually in the United States \[1\]. Paclitaxel and Carboplatin are currently the accepted standard of care...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00976183
Start Date
October 1 2009
End Date
October 1 2012
Last Update
April 10 2017
Active Locations (1)
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1
Gynecologic Oncology Associates
Newport Beach, California, United States, 92663