Bladder Cancer Clinical Trial
Official title:
A Phase II Study of PS-341 in Advanced or Metastatic Urothelial Cancer (Transitional Cell Cancer of the Bladder, Ureter, and Renal Pelvis)
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary
for their growth.
PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with
advanced or metastatic transitional cell cancer of the bladder, renal pelvis, or ureter.
OBJECTIVES:
- 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
drug.
- 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
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