Clinical Trial: Fluorouracil in Treating Patients With Recurrent or Metastatic Bladder Cancer

This study is no longer recruiting patients.

Sponsored by: Medical Research Council
Information provided by: National Cancer Institute (NCI)

Purpose

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.

Condition Treatment or Intervention Phase
recurrent transitional cell cancer of the renal pelvis and ureter
recurrent urethral cancer
childhood kidney/urinary cancer
transitional cell carcinoma of the bladder
recurrent bladder cancer
 Drug: fluorouracil
Phase II

MedlinePlus related topics:  Bladder Cancer;   Cancer;   Kidney Cancer
Genetics Home Reference related topics:  bladder cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Continuous Fluorouracil in Patients with Recurrent Locally Advanced or Metastatic Transitional Cell Urinary Tract Carcinoma

Further Study Details: 

Study start: December 1997

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

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--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

Location Information


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

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

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

      Princess Margaret Hospital, Toronto,  Ontario,  M5G 2M9,  Canada

Canada, Quebec
      Hopital Sainte Justine, Montreal,  Quebec,  H3T 1C5,  Canada

Finland
      Maria Hospital, Helsinki,  FIN-0-0180,  Finland

Netherlands
      Antoni van Leeuwenhoekhuis, Amsterdam,  1066 CX,  Netherlands

New Zealand
      Christchurch Hospital, Christchurch,  1,  New Zealand

Norway
      Norwegian Radium Hospital, Oslo,  N-0310,  Norway

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

United Kingdom
      Royal Preston Hospital, Preston,  PR2 9HT,  United Kingdom

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

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

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

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

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

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

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

      Cookridge Hospital, Leeds,  England,  LS16 6QB,  United Kingdom

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

      University Birmingham, Birmingham,  England,  B15 2TT,  United Kingdom

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

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

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

      Walsgrave Hospital, Coventry,  England,  CV2 2DX,  United Kingdom

      Westminster Hospital, London,  England,  SW1P 2AP,  United Kingdom

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

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

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

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

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

      Royal Hospital for Sick Children, Edinburgh,  Scotland,  United Kingdom

      Royal Infirmary, Glasgow,  Scotland,  G4 0SF,  United Kingdom

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

United Kingdom, Wales
      Llandough Hospital, Penarth,  Wales,  CF6 1XX,  United Kingdom

      Ysbyty Gwynedd, Bangor,  Wales,  United Kingdom

Study chairs or principal investigators

Peter G. Harper,  Study Chair,  Medical Research Council   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000065985; MRC-BA10; EU-97029
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003175
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005