NCT00025155

Ixabepilone in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy

A Phase II Evaluation of Epothilone-B BMS 247550 (NSC # 710428) in the Treatment of Recurrent or Persistent Platinum and Paclitaxel Refractory Ovarian or Primary Peritoneal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

Phase II trial to study the effectiveness of ixabepilone in treating patients who have recurrent or persistent ovarian epithelial or primary peritoneal cancer that has not responded to previous chemotherapy. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die.

Detailed description

PRIMARY OBJECTIVES: I. Determine the antitumor activity of ixabepilone in patients with recurrent or persistent platinum and paclitaxel-refractory ovarian epithelial or primary peritoneal cancer. II. Determine the nature and degree of toxicity of this drug in these patients. OUTLINE: Patients receive ixabepilone IV over 1 hour. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Conditions

• Primary Peritoneal Cavity Cancer
• Recurrent Ovarian Epithelial Cancer

Interventions

Type	Name	Description
DRUG	ixabepilone	Given IV

Timeline

• Start date: 2002-07-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2003-01-27
• Last updated: 2019-07-24
• Results posted: 2015-07-13

Locations

1 site across 1 country: United States