Cisplatin Plus Gemcitabine With or Without Paclitaxel in Treating Patients With Stage IV Urinary Tract Cancer
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring stage IV bladder cancer, transitional cell carcinoma of the bladder, urethral cancer associated with invasive bladder cancer, metastatic transitional cell cancer of the renal pelvis and ureter, regional transitional cell cancer of the renal pelvis and ureter
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage IV transitional cell carcinoma of the urothelium (pure or mixed) including bladder, urethra, ureter, and renal pelvis T4b, any N OR any T, N2-3 OR M1 Ineligible for surgery or radiotherapy with curative intent Measurable or evaluable disease No known CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.25 times normal AST or ALT less than 2.5 times normal Renal: Glomerular filtration rate at least 60 mL/min Calcium normal or clinically insignificant Cardiovascular: No clinically significant cardiac arrhythmia No congestive heart failure No complete bundle branch block No New York Heart Association class III or IV heart disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study participation No psychological, familial, sociological, or geographical condition that would preclude study compliance No grade 3 or 4 infection without neutropenia No other serious concurrent systemic disorder that would preclude study therapy No mental disorder that would preclude study compliance No grade II or greater neuropathy No other prior or concurrent malignancy except appropriately treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, or incidental prostate cancer (T1, Gleason score no greater than 6, and PSA less than 0.5 ng/mL) PRIOR CONCURRENT THERAPY: Biologic therapy: No prior investigational biologic agents (e.g., antiangiogenic products, signal transduction pathway inhibitors, immunomodulators, or monoclonal antibody therapy) At least 4 weeks since prior immunotherapy Chemotherapy: No prior systemic chemotherapy At least 4 weeks since prior local intravesical chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No more than 1 prior course of radiotherapy At least 4 weeks since prior radiotherapy and recovered Surgery: See Disease Characteristics Prior urological procedures to relieve urinary tract obstruction and improve renal function allowed (e.g., ureteral stent or percutaneous nephrostomy)
Sites / Locations
- Veterans Affairs Medical Center - Tucson
- Arizona Cancer Center at University of Arizona Health Sciences Center
- Veterans Affairs Medical Center - Little Rock (McClellan)
- City of Hope Comprehensive Cancer Center
- USC/Norris Comprehensive Cancer Center and Hospital
- Jonsson Comprehensive Cancer Center, UCLA
- Veterans Affairs Outpatient Clinic - Martinez
- Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
- University of California Davis Cancer Center
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- Veterans Affairs Medical Center - Lexington
- Markey Cancer Center at University of Kentucky Chandler Medical Center
- Tulane University School of Medicine
- Veterans Affairs Medical Center - New Orleans
- Louisiana State University Health Sciences Center - Shreveport
- Veterans Affairs Medical Center - Shreveport
- Cancer Research Center at Boston Medical Center
- Veterans Affairs Medical Center - Ann Arbor
- University of Michigan Comprehensive Cancer Center
- Barbara Ann Karmanos Cancer Institute
- Josephine Ford Cancer Center at Henry Ford Hospital
- Providence Cancer Institute at Providence Hospital
- St. Mary's - Duluth Clinic Cancer Center
- Veterans Affairs Medical Center - Biloxi
- University of Mississippi Medical Center
- Veterans Affairs Medical Center - Jackson
- Veterans Affairs Medical Center - Kansas City
- CCOP - Kansas City
- St. Louis University Hospital Cancer Center
- Herbert Irving Comprehensive Cancer Center at Columbia University
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Veterans Affairs Medical Center - Cincinnati
- Charles M. Barrett Cancer Center at University Hospital
- Cleveland Clinic Taussig Cancer Center
- Oklahoma University Medical Center at University of Oklahoma Health Sciences Center
- Veterans Affairs Medical Center - Oklahoma City
- Cancer Institute at Oregon Health and Science University
- Veterans Affairs Medical Center - Portland
- Veterans Affairs Medical Center - Charleston
- Hollings Cancer Center at Medical University of South Carolina
- University of Tennessee Cancer Institute
- Veterans Affairs Medical Center - Memphis
- Harrington Cancer Center
- Veterans Affairs Medical Center - Amarillo
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Brooke Army Medical Center
- University of Texas Medical Branch
- University of Texas - MD Anderson Cancer Center
- Southwest Cancer and Research Center at University Medical Center
- University of Texas Health Science Center at San Antonio
- Veterans Affairs Medical Center - San Antonio (Murphy)
- Huntsman Cancer Institute
- Veterans Affairs Medical Center - Salt Lake City
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- Veterans Affairs Medical Center - Seattle
- Fremantle Hospital
- Kaiser Franz Josef Hospital
- Onze Lieve Vrouw Ziekenhuis Aalst
- Institut Jules Bordet
- Academisch Ziekenhuis der Vrije Universiteit Brussel
- Universitair Ziekenhuis Antwerpen
- CHU Liege - Domaine Universitaire du Sart Tilman
- Tom Baker Cancer Center - Calgary
- Cross Cancer Institute
- Lethbridge Cancer Clinic
- British Columbia Cancer Agency - Centre for the Southern Interior
- Nanaimo Cancer Clinic at Nanaimo Regional General Hospital
- Lions Gate Hospital
- Prostate Centre at Vancouver General Hospital
- British Columbia Cancer Agency
- Providence Health Care - Vancouver
- British Columbia Cancer Agency - Vancouver Island Cancer Centre
- G. Steinhoff Clinical Research
- CancerCare Manitoba
- Moncton Hospital
- Doctor Leon Richard Oncology Centre
- Saint John Regional Hospital
- Newfoundland Cancer Treatment and Research Foundation
- Nova Scotia Cancer Centre
- Cape Breton Cancer Centre
- Royal Victoria Hospital, Barrie
- William Osler Health Centre
- Hamilton and District Urology Association
- Margaret and Charles Juravinski Cancer Centre
- Kingston Regional Cancer Centre
- Grand River Regional Cancer Centre
- London Health Sciences Centre
- Cancer Care Ontario-London Regional Cancer Centre
- Markham Stouffville Hospital
- Trillium Health Centre
- Credit Valley Hospital
- Southlake Regional Health Centre
- North York General Hospital, Ontario
- Sunnybrook and Women's College Health Sciences Centre
- Male Health Centre - Oakville
- Durham Regional Cancer Centre at Lakeridge Health Oshawa
- Ottawa Regional Cancer Centre
- Peterborough Oncology Clinic
- Algoma Reginal Cancer Program at Sault Area Hospital
- Scarborough Hospital - General Site
- Hotel Dieu Health Sciences Hospital - Niagara
- Northeastern Ontario Regional Cancer Centre - Sudbury
- Northwestern Ontario Regional Cancer Care
- Toronto East General Hospital
- Toronto Sunnybrook Regional Cancer Centre
- St. Michael's Hospital - Toronto
- Mount Sinai Hospital - Toronto
- Toronto General Hospital
- Princess Margaret Hospital
- Male Health Centre - North York
- St. Joseph's Health Centre - Toronto
- Humber River Regional Hospital - Weston
- Cancer Care Ontario - Windsor Regional Cancer Centre
- Prince Edward Island Cancer Center at Queen Elizabeth Hospital
- Complexe Hospitalier de la Sagamie
- CHUS-Hopital Fleurimont
- Hopital Charles Lemoyne
- Centre Hospitalier Regional de Lanaudiere
- Hotel-Dieu de Levis
- Maisonneuve-Rosemont Hospital
- Centre Hospitalier de l'Universite de Montreal
- McGill University
- Hotel Dieu de Montreal
- Hopital Sainte Justine
- Hopital Du Sacre-Coeur de Montreal
- Centre Hospitalier Universitaire de Quebec
- Hopital du Saint-Sacrement, Quebec
- L'Hopital Laval
- Allan Blair Cancer Centre
- Saskatoon Cancer Centre
- Centre Hospitalier Regional de Rimouski
- Aarhus Kommunehospital
- Rigshospitalet
- Centre Paul Papin
- Institut Bergonie
- Centre Hospitalier Docteur Duchenne
- Centre Regional Francois Baclesse
- Centre Hospitalier Universitaire Henri Mondor
- Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
- CHU de Grenoble - Hopital de la Tronche
- Centre Hospitalier Departemental
- Centre Oscar Lambret
- Centre Leon Berard
- CHU de la Timone
- Hopital Lapeyronie-CHU Montpellier
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
- Centre Regional Rene Gauducheau
- Hopital Europeen Georges Pompidou
- Institut Curie - Section Medicale
- Hopital Tenon
- Centre Eugene Marquis
- Centre Henri Becquerel
- Centre Rene Huguenin
- Centre Medico-Chirurgical Foch
- Centre Antoine Lacassagne
- Institut Claudius Regaud
- Centre Alexis Vautrin
- Krankenhaus Hohe Warte Mediziniche Klinik
- Charite Humboldt - University Berlin
- Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
- Helios - Klinik Blankenhain
- Universitaetsklinikum Bonn
- Staedtische Kliniken Dortmund
- Universitaetsklinik Duesseldorf
- St. Markus Krankenhaus
- Klinikum der J.W. Goethe Universitaet
- Klinikum Fulda
- Martin Luther Universitaet
- Marienkrankenhaus
- Universitat des Saarlandes Innere Medizin 1
- Klinikum der Friedrich-Schiller Universitaet Jena
- Klinikum der Stadt Ludwigshafen am Rhein
- Staedtisches Krankenhaus Sued
- Medizinische Universitaet Luebeck
- Kreiskrankenhaus Luedenscheid
- Klinikum der Stadt Mannheim
- University of Marburg
- Klinik und Poliklinik fuer Kinderheilkunde
- Klinikum Rechts Der Isar - Technische Universitaet Muenchen
- Klinikum Neubrandenburg
- Klinikum Nuernberg - Klinikum Nord
- Paracelsus Karankenhaus Ruit
- Asklepios Klinik Pasewalk
- Diakonie - Krankenhaus
- Johanniter Kankenhaus Stendal
- Katharinenhospital
- Universitaetsklinikum Tuebingen
- Universitaet Ulm
- Klinikum der Stadt Wolfsburg
- Klinikum St. Marien
- Witten University - Klinikum Wuppertal
- National Institute of Oncology
- Rabin Medical Center - Beilinson Campus
- Assaf Harofeh Medical Center
- Ospedale Santa Croce
- Istituto Scientifico H.San Raffaele
- Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
- Jeroen Bosch Ziekenhuis
- Daniel Den Hoed Cancer Center at Erasmus Medical Center
- Academisch Ziekenhuis Utrecht
- University Hospital - Rotterdam Dijkzigt
- Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
- National Cancer Institute - Bratislava
- Hospital Universitari Germans Trias i Pujol
- Hospital Del Mar
- Hospital Clinic y Provincial de Barcelona
- Hospital General Universitari Vall d'Hebron
- Hospital Juan Canalejo
- Hospital General Universitario De Guadalajara
- Hospital Cuidad de Jaen
- Hospital Arquitecto Marcide
- Hospital Universitario San Carlos
- Hospital Universitario 12 de Octubre
- Hospital Clinico Universitario - Malaga
- Hospital Son Dureta
- Hospsital de Sabadell
- Hospital Universitario Marques de Valdecilla
- Hospital Consorci Sanitari De Terrassa
- Instituto Valenciano De Oncologia
- Hospital Clinico Universitario de Valencia
- Hospital Rio Hortega
- Hospital General De Vic
- Hospital Clinico Universitario
- Princess Royal Hospital
- St. James's University Hospital
- Saint Bartholomew's Hospital
- Guy's and St. Thomas' Hospitals NHS Trust
- Northern Centre for Cancer Treatment at Newcastle General Hospital
- Royal South Hants Hospital
- Royal Marsden Hospital - Sutton
- Velindre Cancer Center at Velinde Hospital