Fluorouracil in Treating Patients With Recurrent or Metastatic Bladder Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003175
First received: November 1, 1999
Last updated: December 3, 2013
Last verified: February 2010
  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 Intervention Phase
Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Urethral Cancer
Drug: fluorouracil
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 45
Study Start Date: December 1997
Study Completion Date: March 2009
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003175

  Hide Study Locations
Locations
Brazil
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
Finland
Maria Hospital
Helsinki, Finland, FIN-0-0180
Netherlands
Antoni van Leeuwenhoekhuis
Amsterdam, Netherlands, 1066 CX
New Zealand
Christchurch Hospital
Christchurch, New Zealand, 1
Norway
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 Children's Hospital
Derby, England, United Kingdom, DE1 3BA
Derbyshire Royal Infirmary
Derby, England, United Kingdom, DE1 2QY
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
St. James's Hospital
Leeds, England, United Kingdom, LS9 7TF
Cookridge Hospital
Leeds, England, United Kingdom, LS16 6QB
University Hospitals of Leicester
Leicester, England, United Kingdom, LE1 5WW
Middlesex Hospital- Meyerstein Institute
London, England, United Kingdom, W1N 8AA
Guy's, King's and St. Thomas' Hospitals Trust
London, England, United Kingdom, SE1 7EH
University College Hospital
London, England, United Kingdom, WC1E 6AU
St. Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
Westminster Hospital
London, England, United Kingdom, SW1P 2AP
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
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
Royal South Hants Hospital
Southampton, England, United Kingdom, SO14 0YG
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
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom
Western General Hospital
Edinburgh, Scotland, United Kingdom, EH4 9NQ
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
Investigators
Study Chair: Peter G. Harper, MD St. Thomas' Hospital
  More Information

Additional Information:
Publications:
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.

ClinicalTrials.gov Identifier: NCT00003175     History of Changes
Other Study ID Numbers: CDR0000065985, MRC-BA10, EU-97029
Study First Received: November 1, 1999
Last Updated: December 3, 2013
Health Authority: United States: Federal Government

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
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urethral Diseases
Kidney Diseases
Ureteral Diseases
Fluorouracil
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014