NCT00182702

Ixabepilone in Treating Patients With Metastatic, Recurrent, or Unresectable Kidney Cancer

A Phase II Trial of BMS 247550 (Ixabepilone) in Advanced Renal Cell Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well ixabepilone works in treating patients with metastatic, recurrent, or unresectable kidney cancer. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing

Detailed description

PRIMARY OBJECTIVES: I. Determine the objective response rate in patients with metastatic, recurrent, or unresectable renal cell carcinoma treated with ixabepilone. SECONDARY OBJECTIVES: I. Determine the progression-free and overall survival rates in patients treated with this drug. II. Determine the toxicity of this drug in these patients. III. Correlate VHL gene mutations with response in patients treated with this drug. IV. Correlate VHL pathway protein expression with response in patients treated with this drug. 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. After completion of study therapy, patients are followed every 9 weeks until disease progression and then every 3 months for up to 2 years.

Conditions

• Clear Cell Renal Cell Carcinoma
• Recurrent Renal Cell Cancer
• Stage III Renal Cell Cancer
• Stage IV Renal Cell Cancer

Interventions

Type	Name	Description
DRUG	ixabepilone	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2005-07-01
• Primary completion: 2007-09-01
• First posted: 2005-09-16
• Last updated: 2013-03-25

Locations

1 site across 1 country: United States