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Bortezomib in Treating Patients With Advanced or Metastatic Transitional Cell Cancer of the Bladder, Renal Pelvis, or Ureter

Phase 2
Completed
Conditions
Transitional Cell Cancer of the Renal Pelvis and Ureter
Bladder 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
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Objective response by RECIST criteria every 6 weeks
Secondary Outcome Measures
NameTimeMethod
Objective response duration
Stable disease duration
Progression-free survival
Overall survival
Toxicity

Trial Locations

Locations (15)

Margaret and Charles Juravinski Cancer Centre

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Hamilton, Ontario, Canada

Decatur Memorial Hospital Cancer Care Institute

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Decatur, Illinois, United States

Princess Margaret Hospital

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Toronto, Ontario, Canada

University of Chicago Cancer Research Center

πŸ‡ΊπŸ‡Έ

Chicago, Illinois, United States

CCOP - Evanston

πŸ‡ΊπŸ‡Έ

Evanston, Illinois, United States

Ingalls Cancer Care Center at Ingalls Memorial Hospital

πŸ‡ΊπŸ‡Έ

Harvey, Illinois, United States

Cardinal Bernardin Cancer Center at Loyola University Medical Center

πŸ‡ΊπŸ‡Έ

Maywood, Illinois, United States

Fort Wayne Medical Oncology and Hematology

πŸ‡ΊπŸ‡Έ

Fort Wayne, Indiana, United States

Central Illinois Hematology Oncology Center

πŸ‡ΊπŸ‡Έ

Springfield, Illinois, United States

Oncology/Hematology Associates of Central Illinois, P.C.

πŸ‡ΊπŸ‡Έ

Peoria, Illinois, United States

CCOP - Northern Indiana CR Consortium

πŸ‡ΊπŸ‡Έ

South Bend, Indiana, United States

Oncology Care Associates, P.L.L.C.

πŸ‡ΊπŸ‡Έ

Saint Joseph, Michigan, United States

London Regional Cancer Program at London Health Sciences Centre

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London, Ontario, Canada

Ottawa Hospital Regional Cancer Centre - General Campus

πŸ‡¨πŸ‡¦

Ottawa, Ontario, Canada

Medical College of Wisconsin Cancer Center

πŸ‡ΊπŸ‡Έ

Milwaukee, Wisconsin, United States

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