Fluorouracil in Treating Patients With Recurrent or Metastatic Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003175
Recruitment Status : Completed
First Posted : April 30, 2004
Last Update Posted : December 4, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer Drug: fluorouracil Phase 2

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  (Clinical Trial)
Estimated Enrollment : 45 participants
Primary Purpose: Treatment
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 Start Date : December 1997
Actual Study Completion Date : March 2009

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003175

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

Publications of Results: Identifier: NCT00003175     History of Changes
Other Study ID Numbers: CDR0000065985
First Posted: April 30, 2004    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: February 2010

Keywords provided by National Cancer Institute (NCI):
recurrent bladder cancer
transitional cell carcinoma of the bladder
recurrent urethral cancer
recurrent transitional cell cancer of the renal pelvis and ureter

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Urethral Neoplasms
Kidney Neoplasms
Ureteral Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urethral Diseases
Kidney Diseases
Ureteral Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs