Bladder CancerPhase 2NCT00003175
Fluorouracil in Treating Patients With Recurrent or Metastatic Bladder Cancer
A Phase 2 study testing fluorouracil in people with Bladder Cancer and Transitional Cell Cancer of the Renal Pelvis and Ureter, run by Medical Research Council at 62 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer
- What is being tested?
- fluorouracil
- How many people
- 45 participants
- Where
- 62 sitesin 8 countries
- Study dates
- Dec 1997to Mar 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
62 sites in 8 countries.
62 sites in 8 countries
United Kingdom52 sites
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
Ysbyty Gwynedd
Bangor, Wales
Royal United Hospital
Bath, England, BA1 3NG
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, BT12 6BE
University Birmingham
Birmingham, England, B15 2TT
Children's Hospital - Birmingham UK
Birmingham, England, B16 8ET
Bradford Hospitals NHS Trust
Bradford, England, BD9 6RJ
Royal Sussex County Hospital
Brighton, England, BN2 5BE
Bristol Royal Hospital for Sick Children
Bristol, England, BS2 8BJ
Bristol Oncology Centre
Bristol, England, BS2 8ED
Addenbrooke's NHS Trust
Cambridge, England, CB2 2QQ
Kent and Canterbury Hospital
Canterbury, England, CT2 7NR
Walsgrave Hospital
Coventry, England, CV2 2DX
Derbyshire Royal Infirmary
Derby, England, DE1 2QY
Derbyshire Children's Hospital
Derby, England, DE1 3BA
Ninewells Hospital and Medical School
Dundee, Scotland, DD1 9SY
Western General Hospital
Edinburgh, Scotland, EH4 9NQ
Royal Hospital for Sick Children
Edinburgh, Scotland
Royal Devon and Exeter Hospital
Exeter, England, EX2 5DW
Beatson Oncology Centre
Glasgow, Scotland, G11 6NT
Royal Infirmary
Glasgow, Scotland, G4 0SF
Gloucester Royal NHS Trust - Glouchester Royal Hospital
Gloucester, England, GL1 3NN
Royal Surrey County Hospital
Guildford, England, GU2 5XX
Royal Free Hospital
Hampstead, London, England, NW3 2QG
Huddersfield Royal Infirmary
Huddersfield, West Yorks, England, HD3 3EA
Cookridge Hospital
Leeds, England, LS16 6QB
St. James's Hospital
Leeds, England, LS9 7TF
University Hospitals of Leicester
Leicester, England, LE1 5WW
St. Bartholomew's Hospital
London, England, EC1A 7BE
Guy's, King's and St. Thomas' Hospitals Trust
London, England, SE1 7EH
Westminster Hospital
London, England, SW1P 2AP
Middlesex Hospital- Meyerstein Institute
London, England, W1N 8AA
University College Hospital
London, England, WC1E 6AU
Manchester Children's Hospitals (NHS Trust)
Manchester, England, M27 SHA
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, L63 4JY
South Tees Acute Hospitals NHS Trust
Middlesbrough, Cleveland, England, TS4 3BW
Royal Victoria Infirmary
Newcastle upon Tyne, England, NE1 4LP
Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
Mount Vernon Hospital
Northwood, England, HA6 2RN
Norfolk & Norwich Hospital
Norwich, England, NR1 3SR
Oxford Radcliffe Hospital
Oxford, England, 0X3 7LJ
Llandough Hospital
Penarth, Wales, CF6 1XX
Portsmouth Hospitals NHS Trust
Portsmouth, England, P03 6AD
Royal Preston Hospital
Preston, PR2 9HT
Children's Hospital - Sheffield
Sheffield, England, S10 2TH
Weston Park Hospital
Sheffield, England, S1O 2SJ
Royal South Hants Hospital
Southampton, England, SO14 0YG
Southampton General Hospital
Southampton, England, SO16 6YD
Royal Marsden Hospital
Sutton, England, SM2 5PT
Princess Royal Hospital
Telford, England, TF6 6TF
Walsall Manor Hospital
Walsall, England, WS2 9PS
Southend General Hospital
Westcliff-on-Sea, England
Canada4 sites
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5
Mount Sinai Hospital - Toronto
Toronto, Ontario, M5G 1X5
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
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
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.
Read the 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.
- Being tested
- fluorouracil
- Keywords
- recurrent bladder cancer, transitional cell carcinoma of the bladder, recurrent urethral cancer, recurrent transitional cell cancer of the renal pelvis and ureter
- Medical subject headings
- Urinary Bladder Neoplasms, Urethral Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorouracilDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2004 (estimated)
- Study startDec 1997
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Research Council
- Sponsor type
- Other government
- Investigators
- Peter G. Harper, MD, Study chair, St. Thomas' Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003175
- Sponsor's protocol ID
- CDR0000065985
- Other IDs
- MRC-BA10, EU-97029
- Status last verified
- Feb 2010
- First submitted
- 1 Nov 1999
- Last updated
- 4 Dec 2013
- Results posted
- No
Publications
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.
PubMed 19269798Highly 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00003175
- Acronym / sponsor ID
- CDR0000065985
- Keywords
- recurrent bladder cancer, transitional cell carcinoma of the bladder, recurrent urethral cancer, recurrent transitional cell cancer of the renal pelvis and ureter
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Medical Research CouncilOther government
- Study start
- Dec 1997
- Study completion
- Mar 2009 (actual)
- First posted
- 30 Apr 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluorouracil | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
- Results publication: PubMed 19269798Highley 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 publicationHighly 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter G. Harper, MD study chair
St. Thomas' Hospital
62 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fluorouracil in people with Bladder Cancer and Transitional Cell Cancer of the Renal Pelvis and Ureter, run by Medical Research Council at 62 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United Kingdom, Canada, Brazil, Finland, Netherlands and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003175, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2013.