Nitrocamptothecin in Treating Patients With Metastatic Cancer of the Urinary Tract
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00006026|
Recruitment Status : Completed
First Posted : March 16, 2004
Last Update Posted : September 24, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer||Drug: rubitecan||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|