Open Label Phase II Study on RFS 2000 (9-Nitro-Camptothecin, 9-NC) Administered as a "5 Days On-2 Days Off" Oral Treatment in Advanced/Metastatic Urothelial Tract Tumors
OBJECTIVES: I. Determine the objective response to nitrocamptothecin in patients with
metastatic urothelial tract tumors. II. Determine the response rate in these patients when
treated with this regimen. III. Determine the duration of objective response in these
patients when treated with this regimen. IV. Characterize the toxicities of this treatment
in this patient population.
OUTLINE: This is a multicenter study. Patients receive oral nitrocamptothecin daily on days
1-5. Treatment continues weekly every 3 weeks for at least 2 courses in the absence of
disease progression or unacceptable toxicity. Patients are followed every 6 weeks until
PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.
Primary Purpose: Treatment
Pierre Fumoleau, MD, PhD
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
United States: Federal Government