Spots Global Cancer Trial Database for Cisplatin Plus Gemcitabine With or Without Paclitaxel in Treating Patients With Stage IV Urinary Tract Cancer
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Trial Identification
Brief Title: Cisplatin Plus Gemcitabine With or Without Paclitaxel in Treating Patients With Stage IV Urinary Tract Cancer
Official Title: Randomized Phase III Study Comparing Paclitaxel/Cisplatin/Gemcitabine and Cisplatin/Gemcitabine in Patients With Metastatic or Locally Advanced Urothelial Cancer Without Prior Systemic Therapy
Study ID: NCT00022191
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective for urinary tract cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus gemcitabine with or without paclitaxel in treating patients who have stage IV urinary tract cancer.
Detailed Description: OBJECTIVES: * Compare the duration of survival of patients with stage IV transitional cell carcinoma of the urothelium treated with cisplatin and gemcitabine with or without paclitaxel. * Compare the duration of progression-free survival, response rates, and duration of response in patients treated with these regimens. * Compare the toxicity of these regimens in these patients. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, WHO performance status (0 vs 1), and presence of metastatic disease (yes vs no). Patients are randomized to one of two treatment arms. * Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and cisplatin IV over 1 hour on day 1 or 2. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive paclitaxel IV over 1 hour on days 1 and 8 followed by cisplatin IV over 1 hour on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for at least 3 years. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 610 patients (305 per treatment arm) will be accrued for this study within 3.04 years.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Veterans Affairs Medical Center - Tucson, Tucson, Arizona, United States
Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona, United States
Veterans Affairs Medical Center - Little Rock (McClellan), Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Veterans Affairs Outpatient Clinic - Martinez, Martinez, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center, Orange, California, United States
University of California Davis Cancer Center, Sacramento, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora, Colorado, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital), Hines, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, United States
Veterans Affairs Medical Center - Lexington, Lexington, Kentucky, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky, United States
Tulane University School of Medicine, New Orleans, Louisiana, United States
Veterans Affairs Medical Center - New Orleans, New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana, United States
Veterans Affairs Medical Center - Shreveport, Shreveport, Louisiana, United States
Cancer Research Center at Boston Medical Center, Boston, Massachusetts, United States
Veterans Affairs Medical Center - Ann Arbor, Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital, Detroit, Michigan, United States
Providence Cancer Institute at Providence Hospital, Southfield, Michigan, United States
St. Mary's - Duluth Clinic Cancer Center, Duluth, Minnesota, United States
Veterans Affairs Medical Center - Biloxi, Biloxi, Mississippi, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Veterans Affairs Medical Center - Jackson, Jackson, Mississippi, United States
Veterans Affairs Medical Center - Kansas City, Kansas City, Missouri, United States
CCOP - Kansas City, Kansas City, Missouri, United States
St. Louis University Hospital Cancer Center, Saint Louis, Missouri, United States
Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, United States
Veterans Affairs Medical Center - Cincinnati, Cincinnati, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Oklahoma City, Oklahoma City, Oklahoma, United States
Cancer Institute at Oregon Health and Science University, Portland, Oregon, United States
Veterans Affairs Medical Center - Portland, Portland, Oregon, United States
Veterans Affairs Medical Center - Charleston, Charleston, South Carolina, United States
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, United States
University of Tennessee Cancer Institute, Memphis, Tennessee, United States
Veterans Affairs Medical Center - Memphis, Memphis, Tennessee, United States
Harrington Cancer Center, Amarillo, Texas, United States
Veterans Affairs Medical Center - Amarillo, Amarillo, Texas, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Del Rio, Texas, United States
Brooke Army Medical Center, Fort Sam Houston, Texas, United States
University of Texas Medical Branch, Galveston, Texas, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
Southwest Cancer and Research Center at University Medical Center, Lubbock, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Salt Lake City, Salt Lake City, Utah, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus, Seattle, Washington, United States
Veterans Affairs Medical Center - Seattle, Seattle, Washington, United States
Fremantle Hospital, Fremantle, Western Australia, Australia
Kaiser Franz Josef Hospital, Vienna, , Austria
Onze Lieve Vrouw Ziekenhuis Aalst, Aalst, , Belgium
Institut Jules Bordet, Brussels, , Belgium
Academisch Ziekenhuis der Vrije Universiteit Brussel, Brussels, , Belgium
Universitair Ziekenhuis Antwerpen, Edegem, , Belgium
CHU Liege - Domaine Universitaire du Sart Tilman, Liege, , Belgium
Tom Baker Cancer Center - Calgary, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
Lethbridge Cancer Clinic, Lethbridge, Alberta, Canada
British Columbia Cancer Agency - Centre for the Southern Interior, Kelowna, British Columbia, Canada
Nanaimo Cancer Clinic at Nanaimo Regional General Hospital, Nanaimo, British Columbia, Canada
Lions Gate Hospital, North Vancouver, British Columbia, Canada
Prostate Centre at Vancouver General Hospital, Vancouver, British Columbia, Canada
British Columbia Cancer Agency, Vancouver, British Columbia, Canada
Providence Health Care - Vancouver, Vancouver, British Columbia, Canada
British Columbia Cancer Agency - Vancouver Island Cancer Centre, Victoria, British Columbia, Canada
G. Steinhoff Clinical Research, Victoria, British Columbia, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
Moncton Hospital, Moncton, New Brunswick, Canada
Doctor Leon Richard Oncology Centre, Moncton, New Brunswick, Canada
Saint John Regional Hospital, Saint John, New Brunswick, Canada
Newfoundland Cancer Treatment and Research Foundation, St. Johns, Newfoundland and Labrador, Canada
Nova Scotia Cancer Centre, Halifax, Nova Scotia, Canada
Cape Breton Cancer Centre, Sydney, Nova Scotia, Canada
Royal Victoria Hospital, Barrie, Barrie, Ontario, Canada
William Osler Health Centre, Brampton, Ontario, Canada
Hamilton and District Urology Association, Hamilton, Ontario, Canada
Margaret and Charles Juravinski Cancer Centre, Hamilton, Ontario, Canada
Kingston Regional Cancer Centre, Kingston, Ontario, Canada
Grand River Regional Cancer Centre, Kitchner, Ontario, Canada
London Health Sciences Centre, London, Ontario, Canada
Cancer Care Ontario-London Regional Cancer Centre, London, Ontario, Canada
Markham Stouffville Hospital, Markham, Ontario, Canada
Trillium Health Centre, Mississauga, Ontario, Canada
Credit Valley Hospital, Mississauga, Ontario, Canada
Southlake Regional Health Centre, Newmarket, Ontario, Canada
North York General Hospital, Ontario, North York, Ontario, Canada
Sunnybrook and Women's College Health Sciences Centre, North York, Ontario, Canada
Male Health Centre - Oakville, Oakville, Ontario, Canada
Durham Regional Cancer Centre at Lakeridge Health Oshawa, Oshawa, Ontario, Canada
Ottawa Regional Cancer Centre, Ottawa, Ontario, Canada
Peterborough Oncology Clinic, Peterborough, Ontario, Canada
Algoma Reginal Cancer Program at Sault Area Hospital, Sault Sainte Marie, Ontario, Canada
Scarborough Hospital - General Site, Scarborough, Ontario, Canada
Hotel Dieu Health Sciences Hospital - Niagara, St. Catharines, Ontario, Canada
Northeastern Ontario Regional Cancer Centre - Sudbury, Sudbury, Ontario, Canada
Northwestern Ontario Regional Cancer Care, Thunder Bay, Ontario, Canada
Toronto East General Hospital, Toronto, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre, Toronto, Ontario, Canada
St. Michael's Hospital - Toronto, Toronto, Ontario, Canada
Mount Sinai Hospital - Toronto, Toronto, Ontario, Canada
Toronto General Hospital, Toronto, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Male Health Centre - North York, Toronto, Ontario, Canada
St. Joseph's Health Centre - Toronto, Toronto, Ontario, Canada
Humber River Regional Hospital - Weston, Weston, Ontario, Canada
Cancer Care Ontario - Windsor Regional Cancer Centre, Windsor, Ontario, Canada
Prince Edward Island Cancer Center at Queen Elizabeth Hospital, Charlottetown, Prince Edward Island, Canada
Complexe Hospitalier de la Sagamie, Chicoutimi, Quebec, Canada
CHUS-Hopital Fleurimont, Fleurimont, Quebec, Canada
Hopital Charles Lemoyne, Greenfield Park, Quebec, Canada
Centre Hospitalier Regional de Lanaudiere, Joliette, Quebec, Canada
Hotel-Dieu de Levis, Levis, Quebec, Canada
Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada
McGill University, Montreal, Quebec, Canada
Hotel Dieu de Montreal, Montreal, Quebec, Canada
Hopital Sainte Justine, Montreal, Quebec, Canada
Hopital Du Sacre-Coeur de Montreal, Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec, Quebec City, Quebec, Canada
Hopital du Saint-Sacrement, Quebec, Quebec City, Quebec, Canada
L'Hopital Laval, Ste-Foy, Quebec, Canada
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
Centre Hospitalier Regional de Rimouski, Quebec, , Canada
Aarhus Kommunehospital, Aarhus, , Denmark
Rigshospitalet, Copenhagen, , Denmark
Centre Paul Papin, Angers, , France
Institut Bergonie, Bordeaux, , France
Centre Hospitalier Docteur Duchenne, Boulogne Sur Mer, , France
Centre Regional Francois Baclesse, Caen, , France
Centre Hospitalier Universitaire Henri Mondor, Creteil, , France
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc, Dijon, , France
CHU de Grenoble - Hopital de la Tronche, Grenoble, , France
Centre Hospitalier Departemental, La Roche Sur Yon, , France
Centre Oscar Lambret, Lille, , France
Centre Leon Berard, Lyon, , France
CHU de la Timone, Marseille, , France
Hopital Lapeyronie-CHU Montpellier, Montpellier, , France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle, Montpellier, , France
Centre Regional Rene Gauducheau, Nantes-Saint Herblain, , France
Hopital Europeen Georges Pompidou, Paris, , France
Institut Curie - Section Medicale, Paris, , France
Hopital Tenon, Paris, , France
Centre Eugene Marquis, Rennes, , France
Centre Henri Becquerel, Rouen, , France
Centre Rene Huguenin, Saint Cloud, , France
Centre Medico-Chirurgical Foch, Suresnes, , France
Centre Antoine Lacassagne, Toulouse, , France
Institut Claudius Regaud, Toulouse, , France
Centre Alexis Vautrin, Vandoeuvre-les-Nancy, , France
Krankenhaus Hohe Warte Mediziniche Klinik, Bayreuth, , Germany
Charite Humboldt - University Berlin, Berlin, , Germany
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin, Berlin, , Germany
Helios - Klinik Blankenhain, Blankenhain, , Germany
Universitaetsklinikum Bonn, Bonn, , Germany
Staedtische Kliniken Dortmund, Dortmund, , Germany
Universitaetsklinik Duesseldorf, Duesseldorf, , Germany
St. Markus Krankenhaus, Frankfurt, , Germany
Klinikum der J.W. Goethe Universitaet, Frankfurt, , Germany
Klinikum Fulda, Fulda, , Germany
Martin Luther Universitaet, Halle, , Germany
Marienkrankenhaus, Hamburg, , Germany
Universitat des Saarlandes Innere Medizin 1, Hamburg, , Germany
Klinikum der Friedrich-Schiller Universitaet Jena, Jena, , Germany
Klinikum der Stadt Ludwigshafen am Rhein, Ludwigshafen am Rhein, , Germany
Staedtisches Krankenhaus Sued, Luebeck, , Germany
Medizinische Universitaet Luebeck, Luebeck, , Germany
Kreiskrankenhaus Luedenscheid, Luedenscheid, , Germany
Klinikum der Stadt Mannheim, Mannheim, , Germany
University of Marburg, Marburg, , Germany
Klinik und Poliklinik fuer Kinderheilkunde, Muenster, , Germany
Klinikum Rechts Der Isar - Technische Universitaet Muenchen, Munich, , Germany
Klinikum Neubrandenburg, Neubrandenburg, , Germany
Klinikum Nuernberg - Klinikum Nord, Nuernberg, , Germany
Paracelsus Karankenhaus Ruit, Ostfildern, , Germany
Asklepios Klinik Pasewalk, Pasewalk, , Germany
Diakonie - Krankenhaus, Rotenburg, , Germany
Johanniter Kankenhaus Stendal, Stendal, , Germany
Katharinenhospital, Stuttgart, , Germany
Universitaetsklinikum Tuebingen, Tuebingen, , Germany
Universitaet Ulm, Ulm, , Germany
Klinikum der Stadt Wolfsburg, Wolfsburg, , Germany
Klinikum St. Marien, Wuppertal, , Germany
Witten University - Klinikum Wuppertal, Wuppertal, , Germany
National Institute of Oncology, Budapest, , Hungary
Rabin Medical Center - Beilinson Campus, Petah-Tikva, , Israel
Assaf Harofeh Medical Center, Zerifin, , Israel
Ospedale Santa Croce, Cuneo, , Italy
Istituto Scientifico H.San Raffaele, Milano, , Italy
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, , Netherlands
Jeroen Bosch Ziekenhuis, NL'S Hertogenbosch, , Netherlands
Daniel Den Hoed Cancer Center at Erasmus Medical Center, Rotterdam, , Netherlands
Academisch Ziekenhuis Utrecht, Utrecht, , Netherlands
University Hospital - Rotterdam Dijkzigt, Utrecht, , Netherlands
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, , Poland
National Cancer Institute - Bratislava, Bratislava, , Slovakia
Hospital Universitari Germans Trias i Pujol, Badalona, , Spain
Hospital Del Mar, Barcelona, , Spain
Hospital Clinic y Provincial de Barcelona, Barcelona, , Spain
Hospital General Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Juan Canalejo, Coruna, , Spain
Hospital General Universitario De Guadalajara, Guadalajara, , Spain
Hospital Cuidad de Jaen, Jaen, , Spain
Hospital Arquitecto Marcide, La Coruna, , Spain
Hospital Universitario San Carlos, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Clinico Universitario - Malaga, Malaga, , Spain
Hospital Son Dureta, Palma De Mallorca, , Spain
Hospsital de Sabadell, Sabadell, , Spain
Hospital Universitario Marques de Valdecilla, Santander, , Spain
Hospital Consorci Sanitari De Terrassa, Terrassa, , Spain
Instituto Valenciano De Oncologia, Valencia, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Hospital Rio Hortega, Valladolid, , Spain
Hospital General De Vic, Vic, , Spain
Hospital Clinico Universitario, Zaragoza, , Spain
Princess Royal Hospital, Hull, England, United Kingdom
St. James's University Hospital, Leeds, England, United Kingdom
Saint Bartholomew's Hospital, London, England, United Kingdom
Guy's and St. Thomas' Hospitals NHS Trust, London, England, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital, Newcastle Upon Tyne, England, United Kingdom
Royal South Hants Hospital, Southampton, England, United Kingdom
Royal Marsden Hospital - Sutton, Sutton, England, United Kingdom
Velindre Cancer Center at Velinde Hospital, Cardiff, Wales, United Kingdom
Contact Details
Name: Joaquim Bellmunt, MD, PhD
Affiliation: Vall d'Hebron University Hospital
Role: STUDY_CHAIR
Name: Stephane Culine, MD
Affiliation: Institut du Cancer de Montpellier - Val d'Aurelle
Role: STUDY_CHAIR
Name: Michael Leahy, MBChB, FRACP, FRCP, FRC Path
Affiliation: Fremantle Hospital
Role: STUDY_CHAIR
Name: Christoph Zielinski, MD
Affiliation: Allgemeines Krankenhaus - Universitatskliniken
Role: STUDY_CHAIR
Name: Malcolm J. Moore, MD
Affiliation: Princess Margaret Hospital, Canada
Role: STUDY_CHAIR
Name: David C. Smith, MD
Affiliation: University of Michigan Rogel Cancer Center
Role: STUDY_CHAIR
Name: Andreas Boehle, MD
Affiliation: Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
Role: STUDY_CHAIR
Name: Jose Baselga, MD
Affiliation: Vall d'Hebron University Hospital
Role: STUDY_CHAIR
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