Kidney Cancer Clinical Trial
Official title:
An Uncontrolled Phase II Multi-Center Trial Evaluating Anti-Tumor Efficacy and Safety of BAY 59-8862 in Patients With Advanced Renal Cell Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of BAY 59-8862 in treating patients who
have advanced kidney cancer.
OBJECTIVES:
- Determine the overall tumor response rate, including complete response (CR) and partial
response (PR) rate, in patients with advanced renal cell cancer treated with BAY
59-8862.
- Determine the overall survival in patients treated with this drug.
- Determine the time to progression in patients treated with this drug.
- Determine the duration of response (CR and PR) in patients treated with this drug.
- Determine the qualitative and quantitative toxicity profile of this drug in this
patient population.
- Determine the pharmacokinetic profile of this drug in selected patients.
OUTLINE: This is a multicenter study.
Patients receive BAY 59-8862 IV over 1 hour on day 1. Courses repeat every 3 weeks in the
absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until disease progression and then every 6 months
thereafter or for up to 2 years.
PROJECTED ACCRUAL: A total of 20-140 patients will be accrued for this study.
;
Primary Purpose: Treatment
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