NCT00095979

Ixabepilone in Treating Patients With Recurrent or Persistent Endometrial Cancer

A Phase II Evaluation of Ixabepilone (BMS-247550) [NCI-Supplied Agent, NSC #710428]) in the Treatment of Recurrent or Persistent Endometrial Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well ixabepilone works in treating patients with recurrent or persistent endometrial cancer.

Detailed description

PRIMARY OBJECTIVES: I. Determine the response rate in patients with recurrent or persistent endometrial adenocarcinoma treated with ixabepilone. II. Determine the nature and degree of toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 2.5 years.

Conditions

• Endometrial Adenocarcinoma
• Recurrent Endometrial Carcinoma
• Stage IV Endometrial Carcinoma

Interventions

Type	Name	Description
DRUG	ixabepilone	Given IV

Timeline

• Start date: 2005-05-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2004-11-09
• Last updated: 2019-07-24
• Results posted: 2015-05-21

Locations

1 site across 1 country: United States