Recurrent Ovarian Carcinoma Clinical Trial
Official title:
A Phase 2 Study of PXD101 in Platinum Resistant Epithelial Ovarian Tumors and Micropapillary/Borderline (LMP) Ovarian Tumors
This phase II trial studies how well belinostat works in treating patients with ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer that have spread to other places in the body or ovarian low malignant potential tumors. Belinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To determine the antitumor activity of PXD 101 as a single agent in the following patient
population using objective response rates (complete and partial): a) Platinum resistant
ovarian carcinoma (progression within 6 months of platinum based therapy); b) Micropapillary
/ borderline (Low Malignant potential) ovarian carcinoma.
SECONDARY OBJECTIVES:
I. To determine the antitumor activity of PXD 101 with regards to stable disease rates,
duration of response, progression- free, median and overall survival rates as well as
determine the safety and tolerability this drug.
TERTIARY OBJECTIVES:
I. To determine the relationship between clinical and pharmacodynamic effects of PXD101 in
patients with platinum resistant and micropapillary tumors undergoing treatment with this
drug.
OUTLINE:
Patients receive belinostat intravenously (IV) over 30 minutes on days 1-5. Courses repeat
every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 5 years.
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