Fluorouracil in Treating Patients With Recurrent or Metastatic Bladder Cancer

December 3, 2013 updated by: Medical Research Council

A Phase II Study of Continuous 5-Fluorouracil (5-FU) in Recurrent Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urinary Tract

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035--003
        • Porto Alegre Hospital
  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • Cancer Care Ontario-London Regional Cancer Centre
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital - Toronto
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • Hopital Sainte Justine
  • Finland
      • Helsinki, Finland, FIN-0-0180
        • Maria Hospital
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Antoni van Leeuwenhoekhuis
  • New Zealand
      • Christchurch, New Zealand, 1
        • Christchurch Hospital
  • Norway
      • Oslo, Norway, N-0310
        • Norwegian Radium Hospital
  • South Africa
      • Cape Town, South Africa, 7925
        • Groote Schuur Hospital, Cape Town
  • United Kingdom
      • Preston, United Kingdom, PR2 9HT
        • Royal Preston Hospital
    • England
      • Bath, England, United Kingdom, BA1 3NG
        • Royal United Hospital
      • Birmingham, England, United Kingdom, B15 2TT
        • University Birmingham
      • Birmingham, England, United Kingdom, B16 8ET
        • Children's Hospital - Birmingham UK
      • Bradford, England, United Kingdom, BD9 6RJ
        • Bradford Hospitals NHS Trust
      • Brighton, England, United Kingdom, BN2 5BE
        • Royal Sussex County Hospital
      • Bristol, England, United Kingdom, BS2 8ED
        • Bristol Oncology Centre
      • Bristol, England, United Kingdom, BS2 8BJ
        • Bristol Royal Hospital for Sick Children
      • Cambridge, England, United Kingdom, CB2 2QQ
        • Addenbrooke's NHS Trust
      • Canterbury, England, United Kingdom, CT2 7NR
        • Kent and Canterbury Hospital
      • Coventry, England, United Kingdom, CV2 2DX
        • Walsgrave Hospital
      • Derby, England, United Kingdom, DE1 2QY
        • Derbyshire Royal Infirmary
      • Derby, England, United Kingdom, DE1 3BA
        • Derbyshire Children's Hospital
      • Exeter, England, United Kingdom, EX2 5DW
        • Royal Devon and Exeter Hospital
      • Gloucester, England, United Kingdom, GL1 3NN
        • Gloucester Royal NHS Trust - Glouchester Royal Hospital
      • Guildford, England, United Kingdom, GU2 5XX
        • Royal Surrey County Hospital
      • Hampstead, London, England, United Kingdom, NW3 2QG
        • Royal Free Hospital
      • Huddersfield, West Yorks, England, United Kingdom, HD3 3EA
        • Huddersfield Royal Infirmary
      • Leeds, England, United Kingdom, LS9 7TF
        • St. James's Hospital
      • Leeds, England, United Kingdom, LS16 6QB
        • Cookridge Hospital
      • Leicester, England, United Kingdom, LE1 5WW
        • University Hospitals of Leicester
      • London, England, United Kingdom, WC1E 6AU
        • University College Hospital
      • London, England, United Kingdom, SE1 7EH
        • Guy's, King's and St. Thomas' Hospitals Trust
      • London, England, United Kingdom, W1N 8AA
        • Middlesex Hospital- Meyerstein Institute
      • London, England, United Kingdom, EC1A 7BE
        • St. Bartholomew's Hospital
      • London, England, United Kingdom, SW1P 2AP
        • Westminster Hospital
      • Manchester, England, United Kingdom, M27 SHA
        • Manchester Children's Hospitals (NHS Trust)
      • Merseyside, England, United Kingdom, L63 4JY
        • Clatterbridge Centre for Oncology NHS Trust
      • Middlesbrough, Cleveland, England, United Kingdom, TS4 3BW
        • South Tees Acute Hospitals NHS Trust
      • Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
        • Newcastle General Hospital
      • Newcastle-upon-Tyne, England, United Kingdom, NE1 4LP
        • Royal Victoria Infirmary
      • Northwood, England, United Kingdom, HA6 2RN
        • Mount Vernon Hospital
      • Norwich, England, United Kingdom, NR1 3SR
        • Norfolk & Norwich Hospital
      • Oxford, England, United Kingdom, 0X3 7LJ
        • Oxford Radcliffe Hospital
      • Portsmouth, England, United Kingdom, P03 6AD
        • Portsmouth Hospitals NHS Trust
      • Sheffield, England, United Kingdom, S10 2TH
        • Children's Hospital - Sheffield
      • Sheffield, England, United Kingdom, S1O 2SJ
        • Weston Park Hospital
      • Southampton, England, United Kingdom, SO16 6YD
        • Southampton General Hospital
      • Southampton, England, United Kingdom, SO14 0YG
        • Royal South Hants Hospital
      • Sutton, England, United Kingdom, SM2 5PT
        • Royal Marsden Hospital
      • Telford, England, United Kingdom, TF6 6TF
        • Princess Royal Hospital
      • Walsall, England, United Kingdom, WS2 9PS
        • Walsall Manor Hospital
      • Westcliff-On-Sea, England, United Kingdom
        • Southend General Hospital
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT12 6BE
        • Royal Belfast Hospital for Sick Children
    • Scotland
      • Aberdeen, Scotland, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary
      • Dundee, Scotland, United Kingdom, DD1 9SY
        • Ninewells Hospital and Medical School
      • Edinburgh, Scotland, United Kingdom, EH4 9NQ
        • Western General Hospital
      • Edinburgh, Scotland, United Kingdom
        • Royal Hospital for Sick Children
      • Glasgow, Scotland, United Kingdom, G11 6NT
        • Beatson Oncology Centre
      • Glasgow, Scotland, United Kingdom, G4 0SF
        • Royal Infirmary
    • Wales
      • Bangor, Wales, United Kingdom
        • Ysbyty Gwynedd
      • Penarth, Wales, United Kingdom, CF6 1XX
        • LLandough Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Research Council

Investigators

  • Study Chair: Peter G. Harper, MD, St. Thomas' Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1997

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

April 29, 2004

First Posted (Estimate)

April 30, 2004

Study Record Updates

Last Update Posted (Estimate)

December 4, 2013

Last Update Submitted That Met QC Criteria

December 3, 2013

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000065985
  • MRC-BA10
  • EU-97029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bladder Cancer

Clinical Trials on fluorouracil

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe