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PXD101 in Treating Patients With Advanced Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer or Ovarian Low Malignant Potential Tumors

2014-08-27 03:45:44 | BioPortfolio

Summary

RATIONALE: PXD101 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well PXD101 works in treating patients with advanced ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer or ovarian low malignant potential tumors .

Description

OBJECTIVES:

Primary

- Determine the antitumor activity of PXD101 as a single agent, in terms of objective response rates (complete and partial), in patients with advanced platinum-resistant ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer or micropapillary or borderline (low malignant potential) ovarian tumors.

Secondary

- Determine the antitumor activity of PXD101, in terms of stable disease rates, duration of response, and progression-free, median, and overall survival rates in these patients.

- Determine the safety and tolerability of this drug in these patients.

Tertiary

- Determine the relationship between clinical and pharmacodynamic effects of PXD101 in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (micropapillary or borderline ovarian tumor vs platinum-resistant ovarian epithelial, primary peritoneal, or fallopian tube cancer).

Patients receive PXD101 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.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Fallopian Tube Cancer

Intervention

belinostat

Location

British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver
British Columbia
Canada
V5Z 4E6

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:45:44-0400

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Medical and Biotech [MESH] Definitions

Diseases involving the FALLOPIAN TUBES including neoplasms (FALLOPIAN TUBE NEOPLASMS); SALPINGITIS; tubo-ovarian abscess; and blockage.

Methods for assessing the patency of the fallopian tubes.

Benign or malignant neoplasms of the FALLOPIAN TUBES. They are uncommon. If they develop, they may be located in the wall or within the lumen as a growth attached to the wall by a stalk.

Formation of an artificial opening in a fallopian tube.

A pair of highly specialized muscular canals extending from the UTERUS to its corresponding OVARY. They provide the means for OVUM collection, and the site for the final maturation of gametes and FERTILIZATION. The fallopian tube consists of an interstitium, an isthmus, an ampulla, an infundibulum, and fimbriae. Its wall consists of three histologic layers: serous, muscular, and an internal mucosal layer lined with both ciliated and secretory cells.

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