PS-341 in Treating Patients With Metastatic Kidney Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of PS-341 in treating patients who have metastatic kidney cancer.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of PS341 (NSC 681239) in Patients With Advanced Renal Cell Carcinoma|
|Study Start Date:||April 2001|
|Primary Completion Date:||April 2004 (Final data collection date for primary outcome measure)|
- Determine the efficacy of PS-341 in patients with metastatic renal cell carcinoma.
- Determine the safety of this drug in these patients.
OUTLINE: This is an open-label study.
Patients receive PS-341 IV over 3-5 seconds twice weekly for 2 weeks. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed at 2 weeks.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 6-19 months.
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Beverly Drucker, MD||Memorial Sloan-Kettering Cancer Center|