BAY 56-3722 in Treating Patients With Recurrent, Unresectable, or Metastatic Kidney Cancer
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.
Stage IV Renal Cell Cancer
Recurrent Renal Cell Cancer
Drug: BAY 56-3722
Procedure: enzyme inhibitor therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study of BAY 56-3722 in Patients With Recurrent, Unresectable, or Metastatic Renal Cell Carcinoma|
- 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.