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NCT00003175

Fluorouracil in Treating Patients With Recurrent or Metastatic Bladder Cancer

Last Updated: 2013-12-04

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

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-12-31

Study Completion Date

2009-03-31

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 fluorouracil given as a continuous infusion in treating patients with recurrent or metastatic bladder cancer.

Detailed Description

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OBJECTIVES: I. Determine the response rate and toxic effects of continuous fluorouracil in patients with recurrent locally advanced or metastatic transitional cell urinary tract carcinoma. II. Determine the feasibility of this treatment in this patient population.

OUTLINE: Patients receive continuous intravenous fluorouracil by a Baxter Infusor for 24 weeks. Patients are evaluated for complete and partial response at 8, 16, and 24 weeks after the start of intravenous fluorouracil. Patients experiencing disease progression or unacceptable toxic effects are removed from the study. Patients are followed monthly for 6 months post treatment.

PROJECTED ACCRUAL: A maximum of 45 patients will be accrued.

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 transitional cell carcinoma of the bladder recurrent urethral cancer 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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fluorouracil

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven recurrent locally advanced or metastatic transitional cell urinary tract carcinoma that has been previously untreated with systemic chemotherapy Pelvic relapse after radiotherapy or surgery No relapse solely within a previously irradiated field Nodal or metastatic disease Lesions within the abdomen or pelvis must be assessed using CT scanning At least one site of disease must be previously unirradiated and assessable for response Bone metastases cannot be used as an indicator lesion Measurable disease

PATIENT CHARACTERISTICS: Age: Not specified Performance Status: Not specified Life Expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Not specified Renal: Glomerular filtration rate at least 50 mL/min Creatinine clearance at least 25 mL/min

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics

Eligible Sex

ALL

Accepts Healthy Volunteers

Principal Investigators

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Peter G. Harper, MD

Role: STUDY_CHAIR

St. Thomas' Hospital

Locations

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Porto Alegre Hospital

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, Canada

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Mount Sinai Hospital - Toronto

Toronto, Ontario, Canada

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Princess Margaret Hospital

Toronto, Ontario, Canada

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Hopital Sainte Justine

Montreal, Quebec, Canada

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Maria Hospital

Helsinki, , Finland

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Antoni van Leeuwenhoekhuis

Amsterdam, , Netherlands

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Christchurch Hospital

Christchurch, , New Zealand

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Norwegian Radium Hospital

Oslo, , Norway

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Groote Schuur Hospital, Cape Town

Cape Town, , South Africa

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Royal United Hospital

Bath, England, United Kingdom

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University Birmingham

Birmingham, England, United Kingdom

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Children's Hospital - Birmingham UK

Birmingham, England, United Kingdom

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Bradford Hospitals NHS Trust

Bradford, England, United Kingdom

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Royal Sussex County Hospital

Brighton, England, United Kingdom

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Bristol Royal Hospital for Sick Children

Bristol, England, United Kingdom

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Bristol Oncology Centre

Bristol, England, United Kingdom

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Addenbrooke's NHS Trust

Cambridge, England, United Kingdom

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Kent and Canterbury Hospital

Canterbury, England, United Kingdom

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Walsgrave Hospital

Coventry, England, United Kingdom

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Derbyshire Royal Infirmary

Derby, England, United Kingdom

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Derbyshire Children's Hospital

Derby, England, United Kingdom

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Royal Devon and Exeter Hospital

Exeter, England, United Kingdom

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Gloucester Royal NHS Trust - Glouchester Royal Hospital

Gloucester, England, United Kingdom

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Royal Surrey County Hospital

Guildford, England, United Kingdom

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Royal Free Hospital

Hampstead, London, England, United Kingdom

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Huddersfield Royal Infirmary

Huddersfield, West Yorks, England, United Kingdom

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Cookridge Hospital

Leeds, England, United Kingdom

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St. James's Hospital

Leeds, England, United Kingdom

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