NCT00021099

Ixabepilone in Treating Patients With Advanced Urinary Tract Cancer

A Phase II Study Of Epothilone B Analogue BMS-247550 (NSC #710428) q21 Days In Advanced Carcinoma Of The Urothelium

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase II trial to study the effectiveness of ixabepilone in treating patients who have progressive or metastatic urinary tract cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

Detailed description

OBJECTIVES: I. Determine the response rate of patients with advanced carcinoma of the urothelium treated with ixabepilone. II. Assess the toxicity of this drug in these patients. OUTLINE: Patients are stratified according to prior treatment with taxanes (yes vs no). Patients receive ixabepilone IV over 3 hours on day 1. Treatment repeats 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 1 year.

Conditions

• Distal Urethral Cancer
• Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter
• Proximal Urethral Cancer
• Recurrent Bladder Cancer
• Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter
• Recurrent Urethral Cancer
• Regional Transitional Cell Cancer of the Renal Pelvis and Ureter
• Stage III Bladder Cancer
• Stage IV Bladder Cancer
• Transitional Cell Carcinoma of the Bladder
• Urethral Cancer Associated With Invasive Bladder Cancer

Interventions

Type	Name	Description
DRUG	ixabepilone	Given IV

Timeline

• Start date: 2001-06-01
• Primary completion: 2007-08-01
• First posted: 2003-10-09
• Last updated: 2013-01-24

Locations

1 site across 1 country: United States