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

• Status: Terminated
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: Female

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, 1998). Currently, no triplet regimen has demonstrated compelling superiority. Therefore, the combination of Paclitaxel, Carboplatin, and Vorinostat is intriguing because of their potential synergy, distinct mechanisms of action, and non-overlapping toxicity.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Associates
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel; Vorinostat

Criteria

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.