Fluorouracil in Treating Patients With Recurrent or Metastatic Bladder Cancer

Bladder Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003175
• Other study ID #: CDR0000065985
• Secondary ID: MRC-BA10EU-97029
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: December 3, 2013
• Start date: December 1997
• Est. completion date: March 2009

Study information

• Verified date: February 2010
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma, Transitional Cell
• Kidney Neoplasms
• Transitional Cell Cancer of the Renal Pelvis and Ureter
• Ureteral Neoplasms
• Urethral Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• fluorouracil

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Medical Research Council

Countries where clinical trial is conducted

Brazil,  Canada,  Finland,  Netherlands,  New Zealand,  Norway,  South Africa,  United Kingdom, 

References & Publications (2)

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 — View 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.