Nitrocamptothecin in Treating Patients With Metastatic Cancer of the Urinary Tract
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have metastatic cancer of the urinary tract.
|Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer||Drug: rubitecan||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
|Study Start Date:||May 2000|
|Primary Completion Date:||October 2001 (Final data collection date for primary outcome measure)|
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 disease progression.
PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006026
|Leuven, Belgium, B-3000|
|Centre Jean Perrin|
|Clermont-Ferrand, France, 63011|
|Centre de Lute Contre le Cancer,Georges-Francois Leclerc|
|Dijon, France, 21079|
|CRLCC Nantes - Atlantique|
|Nantes-Saint Herblain, France, 44805|
|Centre Henri Becquerel|
|Rouen, France, 76038|
|Rambam Medical Center|
|Haifa, Israel, 31096|
|Azienda Ospedaliera di Padova|
|Padova (Padua), Italy, 35128|
|Rotterdam Cancer Institute|
|Rotterdam, Netherlands, 3075 EA|
|Hospital Universitario 12 de Octubre|
|Madrid, Spain, 28041|
|Ospedale San Giovanni|
|Bellinzona, Switzerland, CH-6500|
|Clinique De Genolier|
|Genolier, Switzerland, Ch-1272|
|Study Chair:||Pierre Fumoleau, MD, PhD||Centre Georges Francois Leclerc|