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Spots Global Cancer Trial Database for Nitrocamptothecin in Treating Patients With Metastatic Cancer of the Urinary Tract

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Nitrocamptothecin in Treating Patients With Metastatic Cancer of the Urinary Tract

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 ID: NCT00006026

Interventions

rubitecan

Study Description

Brief Summary: 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.

Detailed Description: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

U.Z. Gasthuisberg, Leuven, , Belgium

Centre Jean Perrin, Clermont-Ferrand, , France

Centre de Lute Contre le Cancer,Georges-Francois Leclerc, Dijon, , France

CRLCC Nantes - Atlantique, Nantes-Saint Herblain, , France

Centre Henri Becquerel, Rouen, , France

Rambam Medical Center, Haifa, , Israel

Azienda Ospedaliera di Padova, Padova (Padua), , Italy

Rotterdam Cancer Institute, Rotterdam, , Netherlands

Hospital Universitario 12 de Octubre, Madrid, , Spain

Ospedale San Giovanni, Bellinzona, , Switzerland

Clinique De Genolier, Genolier, , Switzerland

Contact Details

Name: Pierre Fumoleau, MD, PhD

Affiliation: Centre Georges Francois Leclerc

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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