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| ID | Type | Description | Link |
|---|---|---|---|
| MRC-BA10 | |||
| EU-97029 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluorouracil | Drug |
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
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| Name | Affiliation | Role |
|---|---|---|
| Peter G. Harper, MD | St. Thomas' Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Porto Alegre Hospital | Porto Alegre | Rio Grande do Sul | 90035--003 | Brazil | ||
| Cancer Care Ontario-London Regional Cancer Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19269798 | Result | 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. | |
| Result | 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. |
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| London |
| Ontario |
| N6A 4L6 |
| Canada |
| Mount Sinai Hospital - Toronto | Toronto | Ontario | M5G 1X5 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| Hopital Sainte Justine | Montreal | Quebec | H3T 1C5 | Canada |
| Maria Hospital | Helsinki | FIN-0-0180 | Finland |
| Antoni van Leeuwenhoekhuis | Amsterdam | 1066 CX | Netherlands |
| Christchurch Hospital | Christchurch | 1 | New Zealand |
| Norwegian Radium Hospital | Oslo | N-0310 | Norway |
| Groote Schuur Hospital, Cape Town | Cape Town | 7925 | South Africa |
| Royal United Hospital | Bath | England | BA1 3NG | United Kingdom |
| University Birmingham | Birmingham | England | B15 2TT | United Kingdom |
| Children's Hospital - Birmingham UK | Birmingham | England | B16 8ET | United Kingdom |
| Bradford Hospitals NHS Trust | Bradford | England | BD9 6RJ | United Kingdom |
| Royal Sussex County Hospital | Brighton | England | BN2 5BE | United Kingdom |
| Bristol Royal Hospital for Sick Children | Bristol | England | BS2 8BJ | United Kingdom |
| Bristol Oncology Centre | Bristol | England | BS2 8ED | United Kingdom |
| Addenbrooke's NHS Trust | Cambridge | England | CB2 2QQ | United Kingdom |
| Kent and Canterbury Hospital | Canterbury | England | CT2 7NR | United Kingdom |
| Walsgrave Hospital | Coventry | England | CV2 2DX | United Kingdom |
| Derbyshire Royal Infirmary | Derby | England | DE1 2QY | United Kingdom |
| Derbyshire Children's Hospital | Derby | England | DE1 3BA | United Kingdom |
| Royal Devon and Exeter Hospital | Exeter | England | EX2 5DW | United Kingdom |
| Gloucester Royal NHS Trust - Glouchester Royal Hospital | Gloucester | England | GL1 3NN | United Kingdom |
| Royal Surrey County Hospital | Guildford | England | GU2 5XX | United Kingdom |
| Royal Free Hospital | Hampstead, London | England | NW3 2QG | United Kingdom |
| Huddersfield Royal Infirmary | Huddersfield, West Yorks | England | HD3 3EA | United Kingdom |
| Cookridge Hospital | Leeds | England | LS16 6QB | United Kingdom |
| St. James's Hospital | Leeds | England | LS9 7TF | United Kingdom |
| University Hospitals of Leicester | Leicester | England | LE1 5WW | United Kingdom |
| St. Bartholomew's Hospital | London | England | EC1A 7BE | United Kingdom |
| Guy's, King's and St. Thomas' Hospitals Trust | London | England | SE1 7EH | United Kingdom |
| Westminster Hospital | London | England | SW1P 2AP | United Kingdom |
| Middlesex Hospital- Meyerstein Institute | London | England | W1N 8AA | United Kingdom |
| University College Hospital | London | England | WC1E 6AU | United Kingdom |
| Manchester Children's Hospitals (NHS Trust) | Manchester | England | M27 SHA | United Kingdom |
| Clatterbridge Centre for Oncology NHS Trust | Merseyside | England | L63 4JY | United Kingdom |
| South Tees Acute Hospitals NHS Trust | Middlesbrough, Cleveland | England | TS4 3BW | United Kingdom |
| Royal Victoria Infirmary | Newcastle upon Tyne | England | NE1 4LP | United Kingdom |
| Newcastle General Hospital | Newcastle upon Tyne | England | NE4 6BE | United Kingdom |
| Mount Vernon Hospital | Northwood | England | HA6 2RN | United Kingdom |
| Norfolk & Norwich Hospital | Norwich | England | NR1 3SR | United Kingdom |
| Oxford Radcliffe Hospital | Oxford | England | 0X3 7LJ | United Kingdom |
| Portsmouth Hospitals NHS Trust | Portsmouth | England | P03 6AD | United Kingdom |
| Children's Hospital - Sheffield | Sheffield | England | S10 2TH | United Kingdom |
| Weston Park Hospital | Sheffield | England | S1O 2SJ | United Kingdom |
| Royal South Hants Hospital | Southampton | England | SO14 0YG | United Kingdom |
| Southampton General Hospital | Southampton | England | SO16 6YD | United Kingdom |
| Royal Marsden Hospital | Sutton | England | SM2 5PT | United Kingdom |
| Princess Royal Hospital | Telford | England | TF6 6TF | United Kingdom |
| Walsall Manor Hospital | Walsall | England | WS2 9PS | United Kingdom |
| Southend General Hospital | Westcliff-on-Sea | England | United Kingdom |
| Royal Belfast Hospital for Sick Children | Belfast | Northern Ireland | BT12 6BE | United Kingdom |
| Aberdeen Royal Infirmary | Aberdeen | Scotland | AB25 2ZN | United Kingdom |
| Ninewells Hospital and Medical School | Dundee | Scotland | DD1 9SY | United Kingdom |
| Western General Hospital | Edinburgh | Scotland | EH4 9NQ | United Kingdom |
| Royal Hospital for Sick Children | Edinburgh | Scotland | United Kingdom |
| Beatson Oncology Centre | Glasgow | Scotland | G11 6NT | United Kingdom |
| Royal Infirmary | Glasgow | Scotland | G4 0SF | United Kingdom |
| Ysbyty Gwynedd | Bangor | Wales | United Kingdom |
| Llandough Hospital | Penarth | Wales | CF6 1XX | United Kingdom |
| Royal Preston Hospital | Preston | PR2 9HT | United Kingdom |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D014523 | Urethral Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D014522 | Urethral Diseases |
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| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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