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Home > "F" Clinical Trials Conditions > Fluorouracil in Treating Patients With Recurrent or Metastatic Bladder Cancer

Fluorouracil in Treating Patients With Recurrent or Metastatic Bladder Cancer



Fluorouracil in Treating Patients With Recurrent or Metastatic Bladder Cancer

For Condition: childhood kidney/urinary cancer,recurrent urethral cancer,recurrent transitional cell cancer of the renal pelvis and ureter,transitional cell carcinoma of the bladder,recurrent bladder cancer
Status: No longer recruiting
Sponsor(s): Medical Research Council ,
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY 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 --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior systemic chemotherapy - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics - Surgery: See Disease Characteristics --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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
PeterHarper,  Study Chair,  Medical Research Council

Weston Park Hospital
Sheffield,  England,  S1O 2SJ
United Kingdom
 

University College Hospital
London,  England,  WC1E 6AU
United Kingdom
 

Maria Hospital
Helsinki,  ,  FIN-0-0180
Finland
 

Royal Belfast Hospital for Sick Children
Belfast,  Northern Ireland,  BT12 6BE
United Kingdom
 

Christchurch Hospital
Christchurch,  ,  1
New Zealand
 

Royal Devon and Exeter Hospital
Exeter,  England,  EX2 5DW
United Kingdom
 

Middlesex Hospital- Meyerstein Institute
London,  England,  W1N 8AA
United Kingdom
 

Hopital Sainte Justine
Montreal,  Quebec,  H3T 1C5
Canada
 

Norwegian Radium Hospital
Oslo,  ,  N-0310
Norway
 

South Tees Acute Hospitals NHS Trust
Middlesbrough, Cleveland,  England,  TS4 3BW
United Kingdom
 

Walsall Manor Hospital
Walsall,  England,  WS2 9PS
United Kingdom
 

Bristol Oncology Centre
Bristol,  England,  BS2 8ED
United Kingdom
 

University Birmingham
Birmingham,  England,  B15 2TT
United Kingdom
 

Cookridge Hospital
Leeds,  England,  LS16 6QB
United Kingdom
 

Ysbyty Gwynedd
Bangor,  Wales, 
United Kingdom
 

Princess Margaret Hospital
Toronto,  Ontario,  M5G 2M9
Canada
 

Antoni van Leeuwenhoekhuis
Amsterdam,  ,  1066 CX
Netherlands
 

Bradford Hospitals NHS Trust
Bradford,  England,  BD9 6RJ
United Kingdom
 

Aberdeen Royal Infirmary
Aberdeen,  Scotland,  AB25 2ZN
United Kingdom
 

Norfolk & Norwich Hospital
Norwich,  England,  NR1 3SR
United Kingdom
 

Royal South Hants Hospital
Southampton,  England,  SO14 0YG
United Kingdom
 

Manchester Children's Hospitals (NHS Trust)
Manchester,  England,  M27 SHA
United Kingdom
 

Portsmouth Hospitals NHS Trust
Portsmouth,  England,  P03 6AD
United Kingdom
 

Mount Vernon Hospital
Northwood,  England,  HA6 2RN
United Kingdom
 

Derbyshire Royal Infirmary
Derby,  England,  DE1 2QY
United Kingdom
 

Oxford Radcliffe Hospital
Oxford,  England,  0X3 7LJ
United Kingdom
 

Mount Sinai Hospital - Toronto
Toronto,  Ontario,  M5G 1X5
Canada
 

Royal Marsden Hospital
Sutton,  England,  SM2 5PT
United Kingdom
 

Bristol Royal Hospital for Sick Children
Bristol,  England,  BS2 8BJ
United Kingdom
 

Ninewells Hospital and Medical School
Dundee,  Scotland,  DD1 9SY
United Kingdom
 

Kent and Canterbury Hospital
Canterbury,  England,  CT2 7NR
United Kingdom
 

Groote Schuur Hospital, Cape Town
Cape Town,  ,  7925
South Africa
 

Derbyshire Children's Hospital
Derby,  England,  DE1 3BA
United Kingdom
 

Cancer Care Ontario-London Regional Cancer Centre
London,  Ontario,  N6A 4L6
Canada
 

Addenbrooke's NHS Trust
Cambridge,  England,  CB2 2QQ
United Kingdom
 

Porto Alegre Hospital
Porto Alegre,  Rio Grande do Sul,  90035--003
Brazil
 

University Hospitals of Leicester
Leicester,  England,  LE1 5WW
United Kingdom
 

Royal Surrey County Hospital
Guildford,  England,  GU2 5XX
United Kingdom
 

Royal United Hospital
Bath,  England,  BA1 3NG
United Kingdom
 

Children's Hospital - Sheffield
Sheffield,  England,  S10 2TH
United Kingdom
 

St. James's Hospital
Leeds,  England,  LS9 7TF
United Kingdom
 

Guy's, King's and St. Thomas' Hospitals Trust
London,  England,  SE1 7EH
United Kingdom
 

Huddersfield Royal Infirmary
Huddersfield, West Yorks,  England,  HD3 3EA
United Kingdom
 

Royal Free Hospital
Hampstead, London,  England,  NW3 2QG
United Kingdom
 

Beatson Oncology Centre
Glasgow,  Scotland,  G11 6NT
United Kingdom
 

Royal Preston Hospital
Preston,  ,  PR2 9HT
United Kingdom
 

Royal Infirmary
Glasgow,  Scotland,  G4 0SF
United Kingdom
 

Walsgrave Hospital
Coventry,  England,  CV2 2DX
United Kingdom
 

Llandough Hospital
Penarth,  Wales,  CF6 1XX
United Kingdom
 

Western General Hospital
Edinburgh,  Scotland,  EH4 9NQ
United Kingdom
 

Royal Victoria Infirmary
Newcastle upon Tyne,  England,  NE1 4LP
United Kingdom
 

Royal Sussex County Hospital
Brighton,  England,  BN2 5BE
United Kingdom
 

Princess Royal Hospital
Telford,  England,  TF6 6TF
United Kingdom
 

Clatterbridge Centre for Oncology NHS Trust
Merseyside,  England,  L63 4JY
United Kingdom
 

Newcastle General Hospital
Newcastle upon Tyne,  England,  NE4 6BE
United Kingdom
 

Westminster Hospital
London,  England,  SW1P 2AP
United Kingdom
 

Southend General Hospital
Westcliff-On-Sea,  England, 
United Kingdom
 

St. Bartholomew's Hospital
London,  England,  EC1A 7BE
United Kingdom
 

Children's Hospital - Birmingham UK
Birmingham,  England,  B16 8ET
United Kingdom
 

Royal Hospital for Sick Children
Edinburgh,  Scotland, 
United Kingdom
 

Gloucester Royal NHS Trust - Glouchester Royal Hospital
Gloucester,  England,  GL1 3NN
United Kingdom
 

Southampton General Hospital
Southampton,  England,  SO16 6YD
United Kingdom
 


Additional Information:
Study ID Numbers:
  CDR0000065985;  MRC-BA10,EU-97029
Study Start Date: December 1997
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003175

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