Status and phase
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About
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.
Full description
OBJECTIVES:
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.
Sex
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Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed transitional cell cancer of the urothelium, including the bladder, renal pelvis, or ureter
At least 1 unidimensionally measurable lesion
At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
The following are not considered measurable disease:
No known brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No more than 2 prior chemotherapy regimen for metastatic disease
More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
Prior chemotherapy as a radiosensitizer is allowed* NOTE: *May be administered concurrently with radiotherapy; may be in addition to a single line of therapy for locally advanced or metastatic disease
Endocrine therapy
Radiotherapy
Surgery
Other
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Data sourced from clinicaltrials.gov
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