Phase II Trial of PS-341 (Bortezomib) in Patients With Previously Treated Advanced Urothelial Tract Transitional Cell Carcinoma
I. To determine the efficacy of PS-341 in patients with measurable advanced urothelial
transitional cell carcinoma who have not responded to, or have relapsed after one prior
II. To determine the safety and toxicity of PS-341 administered in this group of patients.
III. To estimate duration of objective response, progression-free survival and overall
survival in this group of patients.
OUTLINE: This is a 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 with a solitary site of disease (i.e., lung or nodal metastases) and who have a
partial response (PR) may be considered for surgical resection. Patients with a PR with
residual disease after salvage surgery are eligible to continue study therapy. Patients who
achieve a complete response, either through resection or bortezomib therapy, receive 2
additional courses of study therapy.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 15-40 patients will be accrued for this study within 13-17
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rates (CR+PR) determined according to the RECIST criteria
95% confidence intervals will be computed using the binomial distribution.
Up to 6 years
Cancer and Leukemia Group B
United States: Food and Drug Administration
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