A PHASE II STUDY OF ARSENIC TRIOXIDE (NSC #706363, IND #57974) IN UROTHELIAL CANCER
I. To determine the efficacy of arsenic trioxide in patients with measurable urothelial
carcinoma of the bladder, urethra, ureter, or renal pelvis.
II. To determine the toxicity of arsenic trioxide administered to patients with urothelial
Patients receive arsenic trioxide IV over 1 hour on days 1-5. Treatment repeats every 28
days for a minimum of 2 courses in the absence of disease progression or unacceptable
toxicity. Patients who achieve complete response receive 2 additional courses.
Patients are followed every 2 months for 1 year after registration and then every 6 months
for 1 year or until disease progression or relapse.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
95% confidence intervals will be computed using binomial distribution.
Up to 2 years
Cancer and Leukemia Group B
United States: Food and Drug Administration
|Cancer and Leukemia Group B||Chicago, Illinois 60606|