A Phase II Study of Continuous 5-Fluorouracil (5-FU) in Recurrent Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urinary Tract
OBJECTIVES: I. Determine the response rate and toxic effects of continuous fluorouracil in
patients with recurrent locally advanced or metastatic transitional cell urinary tract
carcinoma. II. Determine the feasibility of this treatment in this patient population.
OUTLINE: Patients receive continuous intravenous fluorouracil by a Baxter Infusor for 24
weeks. Patients are evaluated for complete and partial response at 8, 16, and 24 weeks after
the start of intravenous fluorouracil. Patients experiencing disease progression or
unacceptable toxic effects are removed from the study. Patients are followed monthly for 6
months post treatment.
PROJECTED ACCRUAL: A maximum of 45 patients will be accrued.
Primary Purpose: Treatment
Peter G. Harper, MD
St. Thomas' Hospital
United States: Federal Government