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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Given IV
UCSF-Mount Zion
San Francisco, California, United States
Response rates (CR+PR) determined according to the RECIST criteria
95% confidence intervals will be computed using the binomial distribution.
Time frame: Up to 6 years
Duration of objective response
The Kaplan-Meier product-limit method will be used to estimate.
Time frame: From the date of the first CR or PR to the date that the patient had disease progression (or death), assessed up to 6 years
Toxicity by type, frequency, and severity
95% confidence intervals for the toxicity rates will be computed using the binomial distribution.
Time frame: Up to 6 years
Progression free survival
The Kaplan-Meier product-limit method will be used to estimate.
Time frame: From the date of initiation of treatment to date of progression or death due to any cause, whichever occurs first, assessed up to 6 years
Overall survival
The Kaplan-Meier product-limit method will be used to estimate.
Time frame: From the date of initiation of treatment to date of death due to any cause, assessed up to 6 years
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