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| Sponsor: | Medical Research Council |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003175 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer |
Drug: fluorouracil |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| 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 |
| Estimated Enrollment: | 45 |
| Study Start Date: | December 1997 |
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Hide Study Locations| Brazil, Rio Grande do Sul | |
| Porto Alegre Hospital | |
| Porto Alegre, Rio Grande do Sul, Brazil, 90035--003 | |
| Canada, Ontario | |
| Cancer Care Ontario-London Regional Cancer Centre | |
| London, Ontario, Canada, N6A 4L6 | |
| Mount Sinai Hospital - Toronto | |
| Toronto, Ontario, Canada, M5G 1X5 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Canada, Quebec | |
| Hopital Sainte Justine | |
| Montreal, Quebec, Canada, H3T 1C5 | |
| Finland | |
| Maria Hospital | |
| Helsinki, Finland, FIN-0-0180 | |
| Netherlands | |
| Antoni van Leeuwenhoekhuis | |
| Amsterdam, Netherlands, 1066 CX | |
| New Zealand | |
| Christchurch Hospital | |
| Christchurch, New Zealand, 1 | |
| Norway | |
| Norwegian Radium Hospital | |
| Oslo, Norway, N-0310 | |
| South Africa | |
| Groote Schuur Hospital, Cape Town | |
| Cape Town, South Africa, 7925 | |
| United Kingdom | |
| Royal Preston Hospital | |
| Preston, United Kingdom, PR2 9HT | |
| United Kingdom, England | |
| Addenbrooke's NHS Trust | |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| Bradford Hospitals NHS Trust | |
| Bradford, England, United Kingdom, BD9 6RJ | |
| Bristol Oncology Centre | |
| Bristol, England, United Kingdom, BS2 8ED | |
| Bristol Royal Hospital for Sick Children | |
| Bristol, England, United Kingdom, BS2 8BJ | |
| Oxford Radcliffe Hospital | |
| Oxford, England, United Kingdom, 0X3 7LJ | |
| Children's Hospital - Sheffield | |
| Sheffield, England, United Kingdom, S10 2TH | |
| Clatterbridge Centre for Oncology NHS Trust | |
| Merseyside, England, United Kingdom, L63 4JY | |
| Cookridge Hospital | |
| Leeds, England, United Kingdom, LS16 6QB | |
| Derbyshire Children's Hospital | |
| Derby, England, United Kingdom, DE1 3BA | |
| Derbyshire Royal Infirmary | |
| Derby, England, United Kingdom, DE1 2QY | |
| Gloucester Royal NHS Trust - Glouchester Royal Hospital | |
| Gloucester, England, United Kingdom, GL1 3NN | |
| Guy's, King's and St. Thomas' Hospitals Trust | |
| London, England, United Kingdom, SE1 7EH | |
| Huddersfield Royal Infirmary | |
| Huddersfield, West Yorks, England, United Kingdom, HD3 3EA | |
| Kent and Canterbury Hospital | |
| Canterbury, England, United Kingdom, CT2 7NR | |
| Manchester Children's Hospitals (NHS Trust) | |
| Manchester, England, United Kingdom, M27 SHA | |
| Middlesex Hospital- Meyerstein Institute | |
| London, England, United Kingdom, W1N 8AA | |
| Mount Vernon Hospital | |
| Northwood, England, United Kingdom, HA6 2RN | |
| Newcastle General Hospital | |
| Newcastle Upon Tyne, England, United Kingdom, NE4 6BE | |
| Norfolk & Norwich Hospital | |
| Norwich, England, United Kingdom, NR1 3SR | |
| Children's Hospital - Birmingham UK | |
| Birmingham, England, United Kingdom, B16 8ET | |
| Portsmouth Hospitals NHS Trust | |
| Portsmouth, England, United Kingdom, P03 6AD | |
| Princess Royal Hospital | |
| Telford, England, United Kingdom, TF6 6TF | |
| Royal Devon and Exeter Hospital | |
| Exeter, England, United Kingdom, EX2 5DW | |
| Royal Free Hospital | |
| Hampstead, London, England, United Kingdom, NW3 2QG | |
| Royal Marsden Hospital | |
| Sutton, England, United Kingdom, SM2 5PT | |
| Royal South Hants Hospital | |
| Southampton, England, United Kingdom, SO14 0YG | |
| Royal Surrey County Hospital | |
| Guildford, England, United Kingdom, GU2 5XX | |
| Royal Sussex County Hospital | |
| Brighton, England, United Kingdom, BN2 5BE | |
| University Birmingham | |
| Birmingham, England, United Kingdom, B15 2TT | |
| Royal Victoria Infirmary | |
| Newcastle-upon-Tyne, England, United Kingdom, NE1 4LP | |
| South Tees Acute Hospitals NHS Trust | |
| Middlesbrough, Cleveland, England, United Kingdom, TS4 3BW | |
| Southampton General Hospital | |
| Southampton, England, United Kingdom, SO16 6YD | |
| Southend General Hospital | |
| Westcliff-On-Sea, England, United Kingdom | |
| St. Bartholomew's Hospital | |
| London, England, United Kingdom, EC1A 7BE | |
| St. James's Hospital | |
| Leeds, England, United Kingdom, LS9 7TF | |
| Royal United Hospital | |
| Bath, England, United Kingdom, BA1 3NG | |
| University College Hospital | |
| London, England, United Kingdom, WC1E 6AU | |
| University Hospitals of Leicester | |
| Leicester, England, United Kingdom, LE1 5WW | |
| Walsall Manor Hospital | |
| Walsall, England, United Kingdom, WS2 9PS | |
| Walsgrave Hospital | |
| Coventry, England, United Kingdom, CV2 2DX | |
| Westminster Hospital | |
| London, England, United Kingdom, SW1P 2AP | |
| Weston Park Hospital | |
| Sheffield, England, United Kingdom, S1O 2SJ | |
| United Kingdom, Northern Ireland | |
| Royal Belfast Hospital for Sick Children | |
| Belfast, Northern Ireland, United Kingdom, BT12 6BE | |
| United Kingdom, Scotland | |
| Aberdeen Royal Infirmary | |
| Aberdeen, Scotland, United Kingdom, AB25 2ZN | |
| Beatson Oncology Centre | |
| Glasgow, Scotland, United Kingdom, G11 6NT | |
| Ninewells Hospital and Medical School | |
| Dundee, Scotland, United Kingdom, DD1 9SY | |
| Royal Hospital for Sick Children | |
| Edinburgh, Scotland, United Kingdom | |
| Royal Infirmary | |
| Glasgow, Scotland, United Kingdom, G4 0SF | |
| Western General Hospital | |
| Edinburgh, Scotland, United Kingdom, EH4 9NQ | |
| United Kingdom, Wales | |
| Llandough Hospital | |
| Penarth, Wales, United Kingdom, CF6 1XX | |
| Ysbyty Gwynedd | |
| Bangor, Wales, United Kingdom | |
| Study Chair: | Peter G. Harper, MD | St. Thomas' Hospital |
More Information
| Study ID Numbers: | CDR0000065985, MRC-BA10, EU-97029 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003175 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent bladder cancer transitional cell carcinoma of the bladder recurrent urethral cancer recurrent transitional cell cancer of the renal pelvis and ureter |
|
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Ureteral Diseases Urogenital Neoplasms Urologic Neoplasms Carcinoma, Transitional Cell Neoplasms by Site Urologic Diseases Kidney Neoplasms Therapeutic Uses |
Urethral Diseases Kidney Diseases Neoplasms by Histologic Type Urinary Bladder Diseases Urinary Bladder Neoplasms Immunosuppressive Agents Pharmacologic Actions Carcinoma Neoplasms Fluorouracil Urethral Neoplasms Ureteral Neoplasms Neoplasms, Glandular and Epithelial |
