Fluorouracil in Treating Patients With Recurrent or Metastatic Bladder Cancer
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Porto Alegre Hospital | Porto Alegre | Rio Grande do Sul | Brazil | 90035--003 |
| 2 | Cancer Care Ontario-London Regional Cancer Centre | London | Ontario | Canada | N6A 4L6 |
| 3 | Mount Sinai Hospital - Toronto | Toronto | Ontario | Canada | M5G 1X5 |
| 4 | Princess Margaret Hospital | Toronto | Ontario | Canada | M5G 2M9 |
| 5 | Hopital Sainte Justine | Montreal | Quebec | Canada | H3T 1C5 |
| 6 | Maria Hospital | Helsinki | Finland | FIN-0-0180 | |
| 7 | Antoni van Leeuwenhoekhuis | Amsterdam | Netherlands | 1066 CX | |
| 8 | Christchurch Hospital | Christchurch | New Zealand | 1 | |
| 9 | Norwegian Radium Hospital | Oslo | Norway | N-0310 | |
| 10 | Groote Schuur Hospital, Cape Town | Cape Town | South Africa | 7925 | |
| 11 | Royal United Hospital | Bath | England | United Kingdom | BA1 3NG |
| 12 | University Birmingham | Birmingham | England | United Kingdom | B15 2TT |
| 13 | Children's Hospital - Birmingham UK | Birmingham | England | United Kingdom | B16 8ET |
| 14 | Bradford Hospitals NHS Trust | Bradford | England | United Kingdom | BD9 6RJ |
| 15 | Royal Sussex County Hospital | Brighton | England | United Kingdom | BN2 5BE |
| 16 | Bristol Royal Hospital for Sick Children | Bristol | England | United Kingdom | BS2 8BJ |
| 17 | Bristol Oncology Centre | Bristol | England | United Kingdom | BS2 8ED |
| 18 | Addenbrooke's NHS Trust | Cambridge | England | United Kingdom | CB2 2QQ |
| 19 | Kent and Canterbury Hospital | Canterbury | England | United Kingdom | CT2 7NR |
| 20 | Walsgrave Hospital | Coventry | England | United Kingdom | CV2 2DX |
| 21 | Derbyshire Royal Infirmary | Derby | England | United Kingdom | DE1 2QY |
| 22 | Derbyshire Children's Hospital | Derby | England | United Kingdom | DE1 3BA |
| 23 | Royal Devon and Exeter Hospital | Exeter | England | United Kingdom | EX2 5DW |
| 24 | Gloucester Royal NHS Trust - Glouchester Royal Hospital | Gloucester | England | United Kingdom | GL1 3NN |
| 25 | Royal Surrey County Hospital | Guildford | England | United Kingdom | GU2 5XX |
| 26 | Royal Free Hospital | Hampstead, London | England | United Kingdom | NW3 2QG |
| 27 | Huddersfield Royal Infirmary | Huddersfield, West Yorks | England | United Kingdom | HD3 3EA |
| 28 | Cookridge Hospital | Leeds | England | United Kingdom | LS16 6QB |
| 29 | St. James's Hospital | Leeds | England | United Kingdom | LS9 7TF |
| 30 | University Hospitals of Leicester | Leicester | England | United Kingdom | LE1 5WW |
| 31 | St. Bartholomew's Hospital | London | England | United Kingdom | EC1A 7BE |
| 32 | Guy's, King's and St. Thomas' Hospitals Trust | London | England | United Kingdom | SE1 7EH |
| 33 | Westminster Hospital | London | England | United Kingdom | SW1P 2AP |
| 34 | Middlesex Hospital- Meyerstein Institute | London | England | United Kingdom | W1N 8AA |
| 35 | University College Hospital | London | England | United Kingdom | WC1E 6AU |
| 36 | Manchester Children's Hospitals (NHS Trust) | Manchester | England | United Kingdom | M27 SHA |
| 37 | Clatterbridge Centre for Oncology NHS Trust | Merseyside | England | United Kingdom | L63 4JY |
| 38 | South Tees Acute Hospitals NHS Trust | Middlesbrough, Cleveland | England | United Kingdom | TS4 3BW |
| 39 | Newcastle General Hospital | Newcastle Upon Tyne | England | United Kingdom | NE4 6BE |
| 40 | Royal Victoria Infirmary | Newcastle-upon-Tyne | England | United Kingdom | NE1 4LP |
| 41 | Mount Vernon Hospital | Northwood | England | United Kingdom | HA6 2RN |
| 42 | Norfolk & Norwich Hospital | Norwich | England | United Kingdom | NR1 3SR |
| 43 | Oxford Radcliffe Hospital | Oxford | England | United Kingdom | 0X3 7LJ |
| 44 | Portsmouth Hospitals NHS Trust | Portsmouth | England | United Kingdom | P03 6AD |
| 45 | Children's Hospital - Sheffield | Sheffield | England | United Kingdom | S10 2TH |
| 46 | Weston Park Hospital | Sheffield | England | United Kingdom | S1O 2SJ |
| 47 | Royal South Hants Hospital | Southampton | England | United Kingdom | SO14 0YG |
| 48 | Southampton General Hospital | Southampton | England | United Kingdom | SO16 6YD |
| 49 | Royal Marsden Hospital | Sutton | England | United Kingdom | SM2 5PT |
| 50 | Princess Royal Hospital | Telford | England | United Kingdom | TF6 6TF |
| 51 | Walsall Manor Hospital | Walsall | England | United Kingdom | WS2 9PS |
| 52 | Southend General Hospital | Westcliff-On-Sea | England | United Kingdom | |
| 53 | Royal Belfast Hospital for Sick Children | Belfast | Northern Ireland | United Kingdom | BT12 6BE |
| 54 | Aberdeen Royal Infirmary | Aberdeen | Scotland | United Kingdom | AB25 2ZN |
| 55 | Ninewells Hospital and Medical School | Dundee | Scotland | United Kingdom | DD1 9SY |
| 56 | Western General Hospital | Edinburgh | Scotland | United Kingdom | EH4 9NQ |
| 57 | Royal Hospital for Sick Children | Edinburgh | Scotland | United Kingdom | |
| 58 | Beatson Oncology Centre | Glasgow | Scotland | United Kingdom | G11 6NT |
| 59 | Royal Infirmary | Glasgow | Scotland | United Kingdom | G4 0SF |
| 60 | Ysbyty Gwynedd | Bangor | Wales | United Kingdom | |
| 61 | Llandough Hospital | Penarth | Wales | United Kingdom | CF6 1XX |
| 62 | Royal Preston Hospital | Preston | United Kingdom | PR2 9HT |
Sponsors and Collaborators
- Medical Research Council
Investigators
- Study Chair: Peter G. Harper, MD, St. Thomas' Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000065985
- MRC-BA10
- EU-97029