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Brief Title: Fluorouracil in Treating Patients With Recurrent or Metastatic Bladder Cancer
Official Title: A Phase II Study of Continuous 5-Fluorouracil (5-FU) in Recurrent Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urinary Tract
Study ID: NCT00003175
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 fluorouracil given as a continuous infusion in treating patients with recurrent or metastatic bladder cancer.
Detailed Description: 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.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Porto Alegre Hospital, Porto Alegre, Rio Grande do Sul, Brazil
Cancer Care Ontario-London Regional Cancer Centre, London, Ontario, Canada
Mount Sinai Hospital - Toronto, Toronto, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Hopital Sainte Justine, Montreal, Quebec, Canada
Maria Hospital, Helsinki, , Finland
Antoni van Leeuwenhoekhuis, Amsterdam, , Netherlands
Christchurch Hospital, Christchurch, , New Zealand
Norwegian Radium Hospital, Oslo, , Norway
Groote Schuur Hospital, Cape Town, Cape Town, , South Africa
Royal United Hospital, Bath, England, United Kingdom
University Birmingham, Birmingham, England, United Kingdom
Children's Hospital - Birmingham UK, Birmingham, England, United Kingdom
Bradford Hospitals NHS Trust, Bradford, England, United Kingdom
Royal Sussex County Hospital, Brighton, England, United Kingdom
Bristol Royal Hospital for Sick Children, Bristol, England, United Kingdom
Bristol Oncology Centre, Bristol, England, United Kingdom
Addenbrooke's NHS Trust, Cambridge, England, United Kingdom
Kent and Canterbury Hospital, Canterbury, England, United Kingdom
Walsgrave Hospital, Coventry, England, United Kingdom
Derbyshire Royal Infirmary, Derby, England, United Kingdom
Derbyshire Children's Hospital, Derby, England, United Kingdom
Royal Devon and Exeter Hospital, Exeter, England, United Kingdom
Gloucester Royal NHS Trust - Glouchester Royal Hospital, Gloucester, England, United Kingdom
Royal Surrey County Hospital, Guildford, England, United Kingdom
Royal Free Hospital, Hampstead, London, England, United Kingdom
Huddersfield Royal Infirmary, Huddersfield, West Yorks, England, United Kingdom
Cookridge Hospital, Leeds, England, United Kingdom
St. James's Hospital, Leeds, England, United Kingdom
University Hospitals of Leicester, Leicester, England, United Kingdom
St. Bartholomew's Hospital, London, England, United Kingdom
Guy's, King's and St. Thomas' Hospitals Trust, London, England, United Kingdom
Westminster Hospital, London, England, United Kingdom
Middlesex Hospital- Meyerstein Institute, London, England, United Kingdom
University College Hospital, London, England, United Kingdom
Manchester Children's Hospitals (NHS Trust), Manchester, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust, Merseyside, England, United Kingdom
South Tees Acute Hospitals NHS Trust, Middlesbrough, Cleveland, England, United Kingdom
Newcastle General Hospital, Newcastle Upon Tyne, England, United Kingdom
Royal Victoria Infirmary, Newcastle-upon-Tyne, England, United Kingdom
Mount Vernon Hospital, Northwood, England, United Kingdom
Norfolk & Norwich Hospital, Norwich, England, United Kingdom
Oxford Radcliffe Hospital, Oxford, England, United Kingdom
Portsmouth Hospitals NHS Trust, Portsmouth, England, United Kingdom
Children's Hospital - Sheffield, Sheffield, England, United Kingdom
Weston Park Hospital, Sheffield, England, United Kingdom
Royal South Hants Hospital, Southampton, England, United Kingdom
Southampton General Hospital, Southampton, England, United Kingdom
Royal Marsden Hospital, Sutton, England, United Kingdom
Princess Royal Hospital, Telford, England, United Kingdom
Walsall Manor Hospital, Walsall, England, United Kingdom
Southend General Hospital, Westcliff-On-Sea, England, United Kingdom
Royal Belfast Hospital for Sick Children, Belfast, Northern Ireland, United Kingdom
Aberdeen Royal Infirmary, Aberdeen, Scotland, United Kingdom
Ninewells Hospital and Medical School, Dundee, Scotland, United Kingdom
Western General Hospital, Edinburgh, Scotland, United Kingdom
Royal Hospital for Sick Children, Edinburgh, Scotland, United Kingdom
Beatson Oncology Centre, Glasgow, Scotland, United Kingdom
Royal Infirmary, Glasgow, Scotland, United Kingdom
Ysbyty Gwynedd, Bangor, Wales, United Kingdom
Llandough Hospital, Penarth, Wales, United Kingdom
Royal Preston Hospital, Preston, , United Kingdom
Name: Peter G. Harper, MD
Affiliation: St. Thomas' Hospital
Role: STUDY_CHAIR