Intravesical Gemcitabine Therapy for BCG-Refractory Superficial Bladder Cancer: A Phase I and Pharmacokinetic Study
OBJECTIVES: I. Determine the maximum tolerated dose of intravesical gemcitabine in patients
with recurrent or refractory superficial bladder cancer. II. Determine the dose-limiting
toxicity and other toxic effects of this regimen in these patients. III. Assess any
responses in patients treated with this regimen.
OUTLINE: This is a dose-escalation, multicenter study. Patients receive intravesical
gemcitabine that is left in the bladder for 2 hours and then removed on day 1. Treatment
continues every 7 days for 6 courses in the absence of disease progression or unacceptable
toxicity. Cohorts of 3-6 patients receive escalating doses of intravesical gemcitabine until
the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding
that at which 2 of 3 or 6 patients experience dose-limiting toxicity. Patients are followed
every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study.
Primary Purpose: Treatment
Donald L. Trump, MD
University of Pittsburgh
United States: Federal Government
|University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15213|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|