Spots Global Cancer Trial Database for Bortezomib in Treating Patients With Advanced or Metastatic Transitional Cell Cancer of the Bladder, Renal Pelvis, or Ureter
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Trial Identification
Brief Title: Bortezomib in Treating Patients With Advanced or Metastatic Transitional Cell Cancer of the Bladder, Renal Pelvis, or Ureter
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)
Study ID: NCT00066352
Interventions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, United States
Margaret and Charles Juravinski Cancer Centre, Hamilton, Ontario, Canada
London Regional Cancer Program at London Health Sciences Centre, London, Ontario, Canada
Ottawa Hospital Regional Cancer Centre - General Campus, Ottawa, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Contact Details
Name: Eric Winquist, MD
Affiliation: London Health Sciences Centre
Role: STUDY_CHAIR
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