Clinical trial NCT00003175: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-04-30
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Porto Alegre Hospital
state: Rio Grande do Sul
city: London
country: Canada
facility: Cancer Care Ontario-London Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital - Toronto
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: Hopital Sainte Justine
state: Quebec
city: Helsinki
country: Finland
facility: Maria Hospital
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoekhuis
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Oslo
country: Norway
facility: Norwegian Radium Hospital
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital, Cape Town
city: Bath
country: United Kingdom
facility: Royal United Hospital
state: England
city: Birmingham
country: United Kingdom
facility: University Birmingham
state: England
city: Birmingham
country: United Kingdom
facility: Children's Hospital - Birmingham UK
state: England
city: Bradford
country: United Kingdom
facility: Bradford Hospitals NHS Trust
state: England
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
state: England
city: Bristol
country: United Kingdom
facility: Bristol Royal Hospital for Sick Children
state: England
city: Bristol
country: United Kingdom
facility: Bristol Oncology Centre
state: England
city: Cambridge
country: United Kingdom
facility: Addenbrooke's NHS Trust
state: England
city: Canterbury
country: United Kingdom
facility: Kent and Canterbury Hospital
state: England
city: Coventry
country: United Kingdom
facility: Walsgrave Hospital
state: England
city: Derby
country: United Kingdom
facility: Derbyshire Royal Infirmary
state: England
city: Derby
country: United Kingdom
facility: Derbyshire Children's Hospital
state: England
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital
state: England
city: Gloucester
country: United Kingdom
facility: Gloucester Royal NHS Trust - Glouchester Royal Hospital
state: England
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
state: England
city: Hampstead, London
country: United Kingdom
facility: Royal Free Hospital
state: England
city: Huddersfield, West Yorks
country: United Kingdom
facility: Huddersfield Royal Infirmary
state: England
city: Leeds
country: United Kingdom
facility: Cookridge Hospital
state: England
city: Leeds
country: United Kingdom
facility: St. James's Hospital
state: England
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester
state: England
city: London
country: United Kingdom
facility: St. Bartholomew's Hospital
state: England
city: London
country: United Kingdom
facility: Guy's, King's and St. Thomas' Hospitals Trust
state: England
city: London
country: United Kingdom
facility: Westminster Hospital
state: England
city: London
country: United Kingdom
facility: Middlesex Hospital- Meyerstein Institute
state: England
city: London
country: United Kingdom
facility: University College Hospital
state: England
city: Manchester
country: United Kingdom
facility: Manchester Children's Hospitals (NHS Trust)
state: England
city: Merseyside
country: United Kingdom
facility: Clatterbridge Centre for Oncology NHS Trust
state: England
city: Middlesbrough, Cleveland
country: United Kingdom
facility: South Tees Acute Hospitals NHS Trust
state: England
city: Newcastle Upon Tyne
country: United Kingdom
facility: Newcastle General Hospital
state: England
city: Newcastle-upon-Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
state: England
city: Northwood
country: United Kingdom
facility: Mount Vernon Hospital
state: England
city: Norwich
country: United Kingdom
facility: Norfolk & Norwich Hospital
state: England
city: Oxford
country: United Kingdom
facility: Oxford Radcliffe Hospital
state: England
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals NHS Trust
state: England
city: Sheffield
country: United Kingdom
facility: Children's Hospital - Sheffield
state: England
city: Sheffield
country: United Kingdom
facility: Weston Park Hospital
state: England
city: Southampton
country: United Kingdom
facility: Royal South Hants Hospital
state: England
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: England
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
state: England
city: Telford
country: United Kingdom
facility: Princess Royal Hospital
state: England
city: Walsall
country: United Kingdom
facility: Walsall Manor Hospital
state: England
city: Westcliff-On-Sea
country: United Kingdom
facility: Southend General Hospital
state: England
city: Belfast
country: United Kingdom
facility: Royal Belfast Hospital for Sick Children
state: Northern Ireland
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
state: Scotland
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and Medical School
state: Scotland
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
state: Scotland
city: Edinburgh
country: United Kingdom
facility: Royal Hospital for Sick Children
state: Scotland
city: Glasgow
country: United Kingdom
facility: Beatson Oncology Centre
state: Scotland
city: Glasgow
country: United Kingdom
facility: Royal Infirmary
state: Scotland
city: Bangor
country: United Kingdom
facility: Ysbyty Gwynedd
state: Wales
city: Penarth
country: United Kingdom
facility: Llandough Hospital
state: Wales
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
Study officials:
affiliation: St. Thomas' Hospital
name: Peter G. Harper, MD
role: STUDY_CHAIR
References:
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.
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.