Back to resultsFluorouracil in Treating Patients With Recurrent or Metastatic Bladder Cancer
Primary Purpose
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
fluorouracil
Sponsored by
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring recurrent bladder cancer, transitional cell carcinoma of the bladder, recurrent urethral cancer, recurrent transitional cell cancer of the renal pelvis and ureter
Eligibility 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
Sites / Locations
- Porto Alegre Hospital
- Cancer Care Ontario-London Regional Cancer Centre
- Mount Sinai Hospital - Toronto
- Princess Margaret Hospital
- Hopital Sainte Justine
- Maria Hospital
- Antoni van Leeuwenhoekhuis
- Christchurch Hospital
- Norwegian Radium Hospital
- Groote Schuur Hospital, Cape Town
- Royal United Hospital
- University Birmingham
- Children's Hospital - Birmingham UK
- Bradford Hospitals NHS Trust
- Royal Sussex County Hospital
- Bristol Royal Hospital for Sick Children
- Bristol Oncology Centre
- Addenbrooke's NHS Trust
- Kent and Canterbury Hospital
- Walsgrave Hospital
- Derbyshire Royal Infirmary
- Derbyshire Children's Hospital
- Royal Devon and Exeter Hospital
- Gloucester Royal NHS Trust - Glouchester Royal Hospital
- Royal Surrey County Hospital
- Royal Free Hospital
- Huddersfield Royal Infirmary
- Cookridge Hospital
- St. James's Hospital
- University Hospitals of Leicester
- St. Bartholomew's Hospital
- Guy's, King's and St. Thomas' Hospitals Trust
- Westminster Hospital
- Middlesex Hospital- Meyerstein Institute
- University College Hospital
- Manchester Children's Hospitals (NHS Trust)
- Clatterbridge Centre for Oncology NHS Trust
- South Tees Acute Hospitals NHS Trust
- Newcastle General Hospital
- Royal Victoria Infirmary
- Mount Vernon Hospital
- Norfolk & Norwich Hospital
- Oxford Radcliffe Hospital
- Portsmouth Hospitals NHS Trust
- Children's Hospital - Sheffield
- Weston Park Hospital
- Royal South Hants Hospital
- Southampton General Hospital
- Royal Marsden Hospital
- Princess Royal Hospital
- Walsall Manor Hospital
- Southend General Hospital
- Royal Belfast Hospital for Sick Children
- Aberdeen Royal Infirmary
- Ninewells Hospital and Medical School
- Western General Hospital
- Royal Hospital for Sick Children
- Beatson Oncology Centre
- Royal Infirmary
- Ysbyty Gwynedd
- Llandough Hospital
- Royal Preston Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00003175
First Posted
November 1, 1999
Last Updated
December 3, 2013
Sponsor
Medical Research Council
1. Study Identification
Unique Protocol Identification Number
NCT00003175
Brief Title
Fluorouracil in Treating Patients With Recurrent or Metastatic Bladder Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
December 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medical Research Council
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
fluorouracil
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter G. Harper, MD
Organizational Affiliation
St. Thomas' Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Porto Alegre Hospital
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035--003
Country
Brazil
Facility Name
Cancer Care Ontario-London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Mount Sinai Hospital - Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Hopital Sainte Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
Maria Hospital
City
Helsinki
ZIP/Postal Code
FIN-0-0180
Country
Finland
Facility Name
Antoni van Leeuwenhoekhuis
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
1
Country
New Zealand
Facility Name
Norwegian Radium Hospital
City
Oslo
ZIP/Postal Code
N-0310
Country
Norway
Facility Name
Groote Schuur Hospital, Cape Town
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Royal United Hospital
City
Bath
State/Province
England
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
University Birmingham
City
Birmingham
State/Province
England
ZIP/Postal Code
B15 2TT
Country
United Kingdom
Facility Name
Children's Hospital - Birmingham UK
City
Birmingham
State/Province
England
ZIP/Postal Code
B16 8ET
Country
United Kingdom
Facility Name
Bradford Hospitals NHS Trust
City
Bradford
State/Province
England
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Royal Sussex County Hospital
City
Brighton
State/Province
England
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Bristol Royal Hospital for Sick Children
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8BJ
Country
United Kingdom
Facility Name
Bristol Oncology Centre
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Addenbrooke's NHS Trust
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Kent and Canterbury Hospital
City
Canterbury
State/Province
England
ZIP/Postal Code
CT2 7NR
Country
United Kingdom
Facility Name
Walsgrave Hospital
City
Coventry
State/Province
England
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Derbyshire Royal Infirmary
City
Derby
State/Province
England
ZIP/Postal Code
DE1 2QY
Country
United Kingdom
Facility Name
Derbyshire Children's Hospital
City
Derby
State/Province
England
ZIP/Postal Code
DE1 3BA
Country
United Kingdom
Facility Name
Royal Devon and Exeter Hospital
City
Exeter
State/Province
England
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Gloucester Royal NHS Trust - Glouchester Royal Hospital
City
Gloucester
State/Province
England
ZIP/Postal Code
GL1 3NN
Country
United Kingdom
Facility Name
Royal Surrey County Hospital
City
Guildford
State/Province
England
ZIP/Postal Code
GU2 5XX
Country
United Kingdom
Facility Name
Royal Free Hospital
City
Hampstead, London
State/Province
England
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Huddersfield Royal Infirmary
City
Huddersfield, West Yorks
State/Province
England
ZIP/Postal Code
HD3 3EA
Country
United Kingdom
Facility Name
Cookridge Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS16 6QB
Country
United Kingdom
Facility Name
St. James's Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
University Hospitals of Leicester
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
St. Bartholomew's Hospital
City
London
State/Province
England
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Guy's, King's and St. Thomas' Hospitals Trust
City
London
State/Province
England
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Westminster Hospital
City
London
State/Province
England
ZIP/Postal Code
SW1P 2AP
Country
United Kingdom
Facility Name
Middlesex Hospital- Meyerstein Institute
City
London
State/Province
England
ZIP/Postal Code
W1N 8AA
Country
United Kingdom
Facility Name
University College Hospital
City
London
State/Province
England
ZIP/Postal Code
WC1E 6AU
Country
United Kingdom
Facility Name
Manchester Children's Hospitals (NHS Trust)
City
Manchester
State/Province
England
ZIP/Postal Code
M27 SHA
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology NHS Trust
City
Merseyside
State/Province
England
ZIP/Postal Code
L63 4JY
Country
United Kingdom
Facility Name
South Tees Acute Hospitals NHS Trust
City
Middlesbrough, Cleveland
State/Province
England
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
Newcastle General Hospital
City
Newcastle Upon Tyne
State/Province
England
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Newcastle-upon-Tyne
State/Province
England
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Mount Vernon Hospital
City
Northwood
State/Province
England
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Norfolk & Norwich Hospital
City
Norwich
State/Province
England
ZIP/Postal Code
NR1 3SR
Country
United Kingdom
Facility Name
Oxford Radcliffe Hospital
City
Oxford
State/Province
England
ZIP/Postal Code
0X3 7LJ
Country
United Kingdom
Facility Name
Portsmouth Hospitals NHS Trust
City
Portsmouth
State/Province
England
ZIP/Postal Code
P03 6AD
Country
United Kingdom
Facility Name
Children's Hospital - Sheffield
City
Sheffield
State/Province
England
ZIP/Postal Code
S10 2TH
Country
United Kingdom
Facility Name
Weston Park Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S1O 2SJ
Country
United Kingdom
Facility Name
Royal South Hants Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO14 0YG
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Princess Royal Hospital
City
Telford
State/Province
England
ZIP/Postal Code
TF6 6TF
Country
United Kingdom
Facility Name
Walsall Manor Hospital
City
Walsall
State/Province
England
ZIP/Postal Code
WS2 9PS
Country
United Kingdom
Facility Name
Southend General Hospital
City
Westcliff-On-Sea
State/Province
England
Country
United Kingdom
Facility Name
Royal Belfast Hospital for Sick Children
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT12 6BE
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Ninewells Hospital and Medical School
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 9NQ
Country
United Kingdom
Facility Name
Royal Hospital for Sick Children
City
Edinburgh
State/Province
Scotland
Country
United Kingdom
Facility Name
Beatson Oncology Centre
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Royal Infirmary
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Facility Name
Ysbyty Gwynedd
City
Bangor
State/Province
Wales
Country
United Kingdom
Facility Name
Llandough Hospital
City
Penarth
State/Province
Wales
ZIP/Postal Code
CF6 1XX
Country
United Kingdom
Facility Name
Royal Preston Hospital
City
Preston
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
19269798
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Learn more about this trial
Fluorouracil in Treating Patients With Recurrent or Metastatic Bladder Cancer
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