Stage IV Bladder Cancer Clinical Trial
Official title:
Phase II Trial of PS-341 (Bortezomib) in Patients With Previously Treated Advanced Urothelial Tract Transitional Cell Carcinoma
Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. This phase II trial is studying how well bortezomib works in treating patients with advanced transitional cell carcinoma of the urothelium.
PRIMARY OBJECTIVES:
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
conventional chemotherapy.
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
months.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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