NCT00301756

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

A Phase 2 Study of PXD101 in Platinum Resistant Epithelial Ovarian Tumors and Micropapillary/Borderline (LMP) Ovarian Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Fallopian Tube Carcinoma
• Primary Peritoneal Carcinoma
• Recurrent Borderline Ovarian Surface Epithelial-Stromal Tumor
• Recurrent Ovarian Carcinoma
• Stage III Borderline Ovarian Surface Epithelial-Stromal Tumor
• Stage III Ovarian Cancer
• Stage IV Borderline Ovarian Surface Epithelial-Stromal Tumor
• Stage IV Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Belinostat	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2006-09-01
• Primary completion: 2009-08-01
• Completion: 2012-12-01
• First posted: 2006-03-13
• Last updated: 2018-08-20
• Results posted: 2016-12-14

Locations

4 sites across 1 country: Canada