Fluorouracil in Treating Patients With Recurrent or Metastatic Bladder Cancer

NCT00003175 | Completed Phase 2

• 3 other identifiers: CDR0000065985MRC-BA10EU-97029
• Study Type: interventional
• Target: 45
• Locations: 8 countries
• Sites: 62

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.

Conditions

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

Keywords

recurrent bladder cancer; transitional cell carcinoma of the bladder; recurrent urethral cancer; recurrent transitional cell cancer of the renal pelvis and ureter

Interventions

fluorouracil DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Medical Research Council: lead

Study Sites (62)

Porto Alegre Hospital

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

Location

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Mount Sinai Hospital - Toronto

Toronto, Ontario, M5G 1X5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Hopital Sainte Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Maria Hospital

Helsinki, FIN-0-0180, Finland

Location

Antoni van Leeuwenhoekhuis

Amsterdam, 1066 CX, Netherlands

Location

Christchurch Hospital

Christchurch, 1, New Zealand

Location

Norwegian Radium Hospital

Oslo, N-0310, Norway

Location

Groote Schuur Hospital, Cape Town

Cape Town, 7925, South Africa

Location

Royal United Hospital

Bath, England, BA1 3NG, United Kingdom

Location

University Birmingham

Birmingham, England, B15 2TT, United Kingdom

Location

Children's Hospital - Birmingham UK

Birmingham, England, B16 8ET, United Kingdom

Location

Bradford Hospitals NHS Trust

Bradford, England, BD9 6RJ, United Kingdom

Location

Royal Sussex County Hospital

Brighton, England, BN2 5BE, United Kingdom

Location

Bristol Royal Hospital for Sick Children

Bristol, England, BS2 8BJ, United Kingdom

Location

Bristol Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

Location

Addenbrooke's NHS Trust

Cambridge, England, CB2 2QQ, United Kingdom

Location

Kent and Canterbury Hospital

Canterbury, England, CT2 7NR, United Kingdom

Location

Walsgrave Hospital

Coventry, England, CV2 2DX, United Kingdom

Location

Derbyshire Royal Infirmary

Derby, England, DE1 2QY, United Kingdom

Location

Derbyshire Children's Hospital

Derby, England, DE1 3BA, United Kingdom

Location

Royal Devon and Exeter Hospital

Exeter, England, EX2 5DW, United Kingdom

Location

Gloucester Royal NHS Trust - Glouchester Royal Hospital

Gloucester, England, GL1 3NN, United Kingdom

Location

Royal Surrey County Hospital

Guildford, England, GU2 5XX, United Kingdom

Location

Royal Free Hospital

Hampstead, London, England, NW3 2QG, United Kingdom

Location

Huddersfield Royal Infirmary

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

Location

Cookridge Hospital

Leeds, England, LS16 6QB, United Kingdom

Location

St. James's Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

University Hospitals of Leicester

Leicester, England, LE1 5WW, United Kingdom

Location

St. Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

Guy's, King's and St. Thomas' Hospitals Trust

London, England, SE1 7EH, United Kingdom

Location

Westminster Hospital

London, England, SW1P 2AP, United Kingdom

Location

Middlesex Hospital- Meyerstein Institute

London, England, W1N 8AA, United Kingdom

Location

University College Hospital

London, England, WC1E 6AU, United Kingdom

Location

Manchester Children's Hospitals (NHS Trust)

Manchester, England, M27 SHA, United Kingdom

Location

Clatterbridge Centre for Oncology NHS Trust

Merseyside, England, L63 4JY, United Kingdom

Location

South Tees Acute Hospitals NHS Trust

Middlesbrough, Cleveland, England, TS4 3BW, United Kingdom

Location

Royal Victoria Infirmary

Newcastle upon Tyne, England, NE1 4LP, United Kingdom

Location

Newcastle General Hospital

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

Location

Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Norfolk & Norwich Hospital

Norwich, England, NR1 3SR, United Kingdom

Location

Oxford Radcliffe Hospital

Oxford, England, 0X3 7LJ, United Kingdom

Location

Portsmouth Hospitals NHS Trust

Portsmouth, England, P03 6AD, United Kingdom

Location

Children's Hospital - Sheffield

Sheffield, England, S10 2TH, United Kingdom

Location

Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Royal South Hants Hospital

Southampton, England, SO14 0YG, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Royal Marsden Hospital

Sutton, England, SM2 5PT, United Kingdom

Location

Princess Royal Hospital

Telford, England, TF6 6TF, United Kingdom

Location

Walsall Manor Hospital

Walsall, England, WS2 9PS, United Kingdom

Location

Southend General Hospital

Westcliff-on-Sea, England, United Kingdom

Location

Royal Belfast Hospital for Sick Children

Belfast, Northern Ireland, BT12 6BE, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Ninewells Hospital and Medical School

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Western General Hospital

Edinburgh, Scotland, EH4 9NQ, United Kingdom

Location

Royal Hospital for Sick Children

Edinburgh, Scotland, United Kingdom

Location

Beatson Oncology Centre

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Royal Infirmary

Glasgow, Scotland, G4 0SF, United Kingdom

Location

Ysbyty Gwynedd

Bangor, Wales, United Kingdom

Location

Llandough Hospital

Penarth, Wales, CF6 1XX, United Kingdom

Location

Royal Preston Hospital

Preston, PR2 9HT, United Kingdom

Location

Related Publications (2)

• Highley MS, Griffiths GO, Uscinska BM, Huddart RA, Barber JB, Parmar MK, Harper PG; NCRI Bladder Cancer Clinical Studies Group. A phase II trial of continuous 5-fluorouracil in recurrent or metastatic transitional cell carcinoma of the urinary tract. Clin Oncol (R Coll Radiol). 2009 Jun;21(5):394-400. doi: 10.1016/j.clon.2009.01.011. Epub 2009 Mar 9.

  PMID: 19269798 RESULT

• Highly M, Griffiths G, Uscinska B, et al.: A phase II trial of continous 5-fluorouracil (5-FU) in recurrent locally advanced or metastatic transitional cell of the urinary tract. Br J Cancer 85(suppl 1): A-P77, 52, 2001.

  RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Urethral Neoplasms

Interventions

Fluorouracil

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Urethral Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Peter G. Harper, MD

  St. Thomas' Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: April 30, 2004
• Study Start: December 1, 1997
• Study Completion: March 1, 2009
• Last Updated: December 4, 2013

Record last verified: 2010-02

Locations

ZA (1); NZ (1); NL (1); NO (1); CA (4); BR (1); GB (52); FI (1)