Bortezomib in Treating Patients With Advanced or Metastatic Transitional Cell Cancer of the Bladder, Renal Pelvis, or Ureter
- Conditions
- Transitional Cell Cancer of the Renal Pelvis and UreterBladder Cancer
- Registration Number
- NCT00066352
- Lead Sponsor
- University Health Network, Toronto
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response by RECIST criteria every 6 weeks
- Secondary Outcome Measures
Name Time Method Objective response duration Stable disease duration Progression-free survival Overall survival Toxicity
Trial Locations
- Locations (15)
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute
🇺🇸Decatur, Illinois, United States
CCOP - Evanston
🇺🇸Evanston, Illinois, United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital
🇺🇸Harvey, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Oncology/Hematology Associates of Central Illinois, P.C.
🇺🇸Peoria, Illinois, United States
Central Illinois Hematology Oncology Center
🇺🇸Springfield, Illinois, United States
Fort Wayne Medical Oncology and Hematology
🇺🇸Fort Wayne, Indiana, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Oncology Care Associates, P.L.L.C.
🇺🇸Saint Joseph, Michigan, United States
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