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Nitrocamptothecin in Treating Patients With Metastatic Cancer of the Urinary Tract

Phase 2
Completed
Conditions
Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Urethral Cancer
Registration Number
NCT00006026
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
21
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (11)

Centre de Lute Contre le Cancer,Georges-Francois Leclerc

🇫🇷

Dijon, France

Azienda Ospedaliera di Padova

🇮🇹

Padova (Padua), Italy

Centre Henri Becquerel

🇫🇷

Rouen, France

Ospedale San Giovanni

🇨🇭

Bellinzona, Switzerland

Rotterdam Cancer Institute

🇳🇱

Rotterdam, Netherlands

Hospital Universitario 12 de Octubre

🇪🇸

Madrid, Spain

CRLCC Nantes - Atlantique

🇫🇷

Nantes-Saint Herblain, France

Rambam Medical Center

🇮🇱

Haifa, Israel

U.Z. Gasthuisberg

🇧🇪

Leuven, Belgium

Centre Jean Perrin

🇫🇷

Clermont-Ferrand, France

Clinique De Genolier

🇨🇭

Genolier, Switzerland

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