A Phase II Study of PS-341 in Advanced or Metastatic Urothelial Cancer (Transitional Cell Cancer of the Bladder, Ureter, and Renal Pelvis)
- Determine the response rate and duration of response in patients with advanced or
metastatic transitional cell cancer of the bladder, renal pelvis, or ureter when
treated with bortezomib.
- Determine the 1-year, median, and overall survival rate of patients treated with this
- Determine the stable disease rate and duration and time to progression in patients
treated with this drug.
- Determine the toxicity of this drug in these patients.
- Correlate baseline and post-treatment levels of NF-kappaB and HIF-1 alpha in tumor
biopsies with clinical outcome in patients treated with this drug.
OUTLINE: This is a nonrandomized, open-label, multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat
every 21 days in the absence of disease progression or unacceptable toxicity. Patients in
complete remission (CR) may receive up to 2 courses after confirmation of CR.
Patients are followed within 3 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within
approximately 6.6-17.5 months.
Masking: Open Label, Primary Purpose: Treatment
Objective response by RECIST criteria every 6 weeks
Eric Winquist, MD
London Regional Cancer Program at London Health Sciences Centre
United States: Federal Government
|Cardinal Bernardin Cancer Center at Loyola University Medical Center||Maywood, Illinois 60153-5500|
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Medical College of Wisconsin Cancer Center||Milwaukee, Wisconsin 53226|
|CCOP - Evanston||Evanston, Illinois 60201|
|CCOP - Northern Indiana CR Consortium||South Bend, Indiana 46601|
|Oncology/Hematology Associates of Central Illinois, P.C.||Peoria, Illinois 61602|
|Central Illinois Hematology Oncology Center||Springfield, Illinois 62701|
|Decatur Memorial Hospital Cancer Care Institute||Decatur, Illinois 62526|
|Ingalls Cancer Care Center at Ingalls Memorial Hospital||Harvey, Illinois 60426|
|Fort Wayne Medical Oncology and Hematology||Fort Wayne, Indiana 46815|
|Oncology Care Associates, P.L.L.C.||Saint Joseph, Michigan 49085|