Stage IV Renal Cell Cancer Clinical Trial
Official title:
Phase II Study of BAY 56-3722 in Patients With Recurrent, Unresectable, or Metastatic Renal Cell Carcinoma
RATIONALE: BAY 56-3722 may stop the growth of cancer cells by blocking the enzymes necessary
for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of BAY 56-3722 in treating patients who
have recurrent, unresectable, or metastatic kidney cancer.
OBJECTIVES:
- Determine the tumor response rate of patients with recurrent, unresectable, or
metastatic renal cell carcinoma treated with BAY 56-3722.
- Determine the duration of response, time to progression, and survival of patients
treated with this drug.
- Determine the qualitative and quantitative toxic effects of this drug in these
patients.
- Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive BAY 56-3722 IV over 30 minutes on days 1-3. Treatment repeats every 3 weeks
for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 20-140 patients will be accrued for this study.
;
Primary Purpose: Treatment
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