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Nitrocamptothecin in Treating Patients With Metastatic Cancer of the Urinary Tract

NCT ID: NCT00006026

Last Updated: 2012-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-05-31

Brief Summary

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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

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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.

Conditions

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Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer

Keywords

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recurrent bladder cancer stage IV bladder cancer transitional cell carcinoma of the bladder squamous cell carcinoma of the bladder adenocarcinoma of the bladder recurrent urethral cancer anterior urethral cancer posterior urethral cancer urethral cancer associated with invasive bladder cancer metastatic transitional cell cancer of the renal pelvis and ureter regional transitional cell cancer of the renal pelvis and ureter recurrent transitional cell cancer of the renal pelvis and ureter

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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rubitecan

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed metastatic or unresectable primary carcinoma of the urinary tract including bladder, ureter, and renal pelvis Transitional cell carcinoma OR Mixed cell carcinoma OR Squamous cell carcinoma OR Adenocarcinoma Measurable disease At least 20 mm by conventional techniques OR At least 10 mm by spiral CT scan No symptomatic brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) Alkaline phosphatase and transaminases no greater than 2.5 times ULN (no greater than 5 times ULN in case of hepatic metastases) Renal: Creatinine no greater than 1.7 mg/dL Cardiovascular: Normal cardiac function No ischemic disease in past 6 months Other: Not pregnant or nursing Fertile patients must use effective contraception No other prior malignancies except cone biopsied carcinoma of the cervix or adequately treated basal or squamous cell skin carcinoma No concurrent unstable systemic disease or active uncontrolled infection No psychological, familial, sociological, or geographical condition that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Must have received 1 prior chemotherapy regimen for advanced or metastatic disease At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: At least 14 days since prior major surgery Other: No other concurrent anticancer agents No other concurrent investigational therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre Fumoleau, MD, PhD

Role: STUDY_CHAIR

Centre Georges Francois Leclerc

Locations

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U.Z. Gasthuisberg

Leuven, , Belgium

Site Status

Centre Jean Perrin

Clermont-Ferrand, , France

Site Status

Centre de Lute Contre le Cancer,Georges-Francois Leclerc

Dijon, , France

Site Status

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, , France

Site Status

Centre Henri Becquerel

Rouen, , France

Site Status

Rambam Medical Center

Haifa, , Israel

Site Status

Azienda Ospedaliera di Padova

Padova (Padua), , Italy

Site Status

Rotterdam Cancer Institute

Rotterdam, , Netherlands

Site Status

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

Ospedale San Giovanni

Bellinzona, , Switzerland

Site Status

Clinique De Genolier

Genolier, , Switzerland

Site Status

Countries

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Belgium France Israel Italy Netherlands Spain Switzerland

Other Identifiers

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EORTC-16996U

Identifier Type: -

Identifier Source: secondary_id

EORTC-16996U

Identifier Type: -

Identifier Source: org_study_id