Cisplatin Plus Gemcitabine With or Without Paclitaxel in Treating Patients With Stage IV Urinary Tract Cancer

June 11, 2013 updated by: European Organisation for Research and Treatment of Cancer - EORTC

Randomized Phase III Study Comparing Paclitaxel/Cisplatin/Gemcitabine and Cisplatin/Gemcitabine in Patients With Metastatic or Locally Advanced Urothelial Cancer Without Prior Systemic Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

608

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Fremantle Hospital
  • Austria
      • Vienna, Austria, A-1100
        • Kaiser Franz Josef Hospital
  • Belgium
      • Aalst, Belgium, B-9300
        • Onze Lieve Vrouw Ziekenhuis Aalst
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Brussels, Belgium, 1090
        • Academisch Ziekenhuis der Vrije Universiteit Brussel
      • Edegem, Belgium, B-2650
        • Universitair Ziekenhuis Antwerpen
      • Liege, Belgium, B-4000
        • CHU Liege - Domaine Universitaire du Sart Tilman
  • Canada
      • Quebec, Canada, G1S 4L8
        • Centre Hospitalier Regional De Rimouski
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Center - Calgary
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
      • Lethbridge, Alberta, Canada, T1J 1W5
        • Lethbridge Cancer Clinic
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • British Columbia Cancer Agency - Centre for the Southern Interior
      • Nanaimo, British Columbia, Canada, V9S 2B7
        • Nanaimo Cancer Clinic at Nanaimo Regional General Hospital
      • North Vancouver, British Columbia, Canada, V7L 2P9
        • Lions Gate Hospital
      • Vancouver, British Columbia, Canada, V5Z 3J5
        • Prostate Centre at Vancouver General Hospital
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • British Columbia Cancer Agency
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Providence Health Care - Vancouver
      • Victoria, British Columbia, Canada, V8V 3N1
        • G. Steinhoff Clinical Research
      • Victoria, British Columbia, Canada, V8R 6V5
        • British Columbia Cancer Agency - Vancouver Island Cancer Centre
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6ZB
        • Moncton Hospital
      • Moncton, New Brunswick, Canada, E1C 8X3
        • Doctor Leon Richard Oncology Centre
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Saint John Regional Hospital
    • Newfoundland and Labrador
      • St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
        • Newfoundland Cancer Treatment and Research Foundation
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Nova Scotia Cancer Centre
      • Sydney, Nova Scotia, Canada, B1P 1P3
        • Cape Breton Cancer Centre
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Royal Victoria Hospital, Barrie
      • Brampton, Ontario, Canada, L6W 2Z8
        • William Osler Health Centre
      • Hamilton, Ontario, Canada, L8V 5C2
        • Margaret and Charles Juravinski Cancer Centre
      • Hamilton, Ontario, Canada, L8N 1T8
        • Hamilton And District Urology Association
      • Kingston, Ontario, Canada, K7L 5P9
        • Kingston Regional Cancer Centre
      • Kitchner, Ontario, Canada, N2G 1G3
        • Grand River Regional Cancer Centre
      • London, Ontario, Canada, N6A 4G5
        • London Health Sciences Centre
      • London, Ontario, Canada, N6A 4L6
        • Cancer Care Ontario-London Regional Cancer Centre
      • Markham, Ontario, Canada, L6B IAI
        • Markham Stouffville Hospital
      • Mississauga, Ontario, Canada, L5B 1B8
        • Trillium Health Centre
      • Mississauga, Ontario, Canada, L5M 2N1
        • Credit Valley Hospital
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Southlake Regional Health Centre
      • North York, Ontario, Canada, M2K 1E1
        • North York General Hospital, Ontario
      • North York, Ontario, Canada, M4N 3M5
        • Sunnybrook and Women's College Health Sciences Centre
      • Oakville, Ontario, Canada, L6H 3PI
        • Male Health Centre - Oakville
      • Oshawa, Ontario, Canada, L1G 2B9
        • Durham Regional Cancer Centre at Lakeridge Health Oshawa
      • Ottawa, Ontario, Canada, K1H 1C4
        • Ottawa Regional Cancer Centre
      • Peterborough, Ontario, Canada, K9H 7B6
        • Peterborough Oncology Clinic
      • Sault Sainte Marie, Ontario, Canada, P6B 1Y5
        • Algoma Reginal Cancer Program at Sault Area Hospital
      • Scarborough, Ontario, Canada, M1P 2V5
        • Scarborough Hospital - General Site
      • St. Catharines, Ontario, Canada, L2R 5K3
        • Hotel Dieu Health Sciences Hospital - Niagara
      • Sudbury, Ontario, Canada, P3E 5J1
        • Northeastern Ontario Regional Cancer Centre - Sudbury
      • Thunder Bay, Ontario, Canada, P7B 6V4
        • Northwestern Ontario Regional Cancer Care
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
      • Toronto, Ontario, Canada, M4C 3E7
        • Toronto East General Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Toronto Sunnybrook Regional Cancer Centre
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital - Toronto
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital - Toronto
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
      • Toronto, Ontario, Canada, M6R 1B5
        • St. Joseph's Health Centre - Toronto
      • Toronto, Ontario, Canada, M6A 3B5
        • Male Health Centre - North York
      • Weston, Ontario, Canada, M9N 1N8
        • Humber River Regional Hospital - Weston
      • Windsor, Ontario, Canada, N8W 2X3
        • Cancer Care Ontario - Windsor Regional Cancer Centre
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada, C1A 8T5
        • Prince Edward Island Cancer Center at Queen Elizabeth Hospital
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Complexe Hospitalier de la Sagamie
      • Fleurimont, Quebec, Canada, J1H 5N4
        • CHUS-Hopital Fleurimont
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Hopital Charles LeMoyne
      • Joliette, Quebec, Canada, J6E 6J2
        • Centre Hospitalier Régional de Lanaudière
      • Levis, Quebec, Canada, G6V 3Z1
        • Hotel-Dieu de Levis
      • Montreal, Quebec, Canada, H2W 1S6
        • McGill University
      • Montreal, Quebec, Canada, H1T 2M4
        • Maisonneuve-Rosemont Hospital
      • Montreal, Quebec, Canada, H2W 1T8
        • Hotel Dieu de Montreal
      • Montreal, Quebec, Canada, H4J 1C5
        • Hôpital du Sacré-Coeur de Montreal
      • Montreal, Quebec, Canada, H3T 1C5
        • Hopital Sainte Justine
      • Montreal, Quebec, Canada, H2L-4M1
        • Centre Hospitalier de l'Université de Montréal
      • Quebec City, Quebec, Canada, G1R 2J6
        • Centre Hospitalier Universitaire de Quebec
      • Quebec City, Quebec, Canada, G1S 4L8
        • Hopital du Saint-Sacrement, Quebec
      • Ste-Foy, Quebec, Canada, G1V 4G5
        • L'Hopital Laval
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre
  • Denmark
      • Aarhus, Denmark, DK-8000
        • Aarhus Kommunehospital
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
  • France
      • Angers, France, 49036
        • Centre Paul Papin
      • Bordeaux, France, 33076
        • Institut Bergonié
      • Boulogne Sur Mer, France, 62200
        • Centre Hospitalier Docteur Duchenne
      • Caen, France, 14076
        • Centre Regional Francois Baclesse
      • Creteil, France, 94010
        • Centre Hospitalier Universitaire Henri Mondor
      • Dijon, France, 21079
        • Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
      • Grenoble, France, 38043
        • CHU de Grenoble - Hopital de la Tronche
      • La Roche Sur Yon, France, F-85025
        • Centre Hospitalier departemental
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lyon, France, 69373
        • Centre Léon Bérard
      • Marseille, France, 13385
        • CHU de la Timone
      • Montpellier, France, 34298
        • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
      • Montpellier, France, 34295
        • Hopital Lapeyronie-CHU Montpellier
      • Nantes-Saint Herblain, France, 44805
        • Centre Regional Rene Gauducheau
      • Paris, France, 75015
        • Hôpital Européen Georges Pompidou
      • Paris, France, 75970
        • Hôpital Tenon
      • Paris, France, 75248
        • Institut Curie - Section Medicale
      • Rennes, France, 35042
        • Centre Eugène Marquis
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Saint Cloud, France, 92211
        • Centre René Huguenin
      • Suresnes, France, 92151
        • Centre Médico-Chirurgical Foch
      • Toulouse, France, 31052
        • Institut Claudius Regaud
      • Toulouse, France, 31052
        • Centre Antoine Lacassagne
      • Vandoeuvre-les-Nancy, France, 54511
        • Centre Alexis Vautrin
  • Germany
      • Bayreuth, Germany, 95445
        • Krankenhaus Hohe Warte Mediziniche Klinik
      • Berlin, Germany, D-10117
        • Charite Humboldt - University Berlin
      • Berlin, Germany, D-12200
        • Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
      • Blankenhain, Germany, 99444
        • Helios - Klinik Blankenhain
      • Bonn, Germany, D-53105
        • Universitaetsklinikum Bonn
      • Dortmund, Germany, 44143
        • Staedtische Kliniken Dortmund
      • Duesseldorf, Germany, D-40225
        • Universitaetsklinik Duesseldorf
      • Frankfurt, Germany, D-60590
        • Klinikum der J.W. Goethe Universitaet
      • Frankfurt, Germany, 60431
        • St. Markus Krankenhaus
      • Fulda, Germany, D-36013
        • Klinikum Fulda
      • Halle, Germany, D-06097
        • Martin Luther Universitaet
      • Hamburg, Germany, 22087
        • Marienkrankenhaus
      • Hamburg, Germany, D-66421
        • Universitat des Saarlandes Innere Medizin 1
      • Jena, Germany, D-07740
        • Klinikum der Friedrich-Schiller Universitaet Jena
      • Ludwigshafen am Rhein, Germany, D-67063
        • Klinikum der Stadt Ludwigshafen am Rhein
      • Luebeck, Germany, 23560
        • Staedtisches Krankenhaus Sued
      • Luebeck, Germany, D-23538
        • Medizinische Universitaet Luebeck
      • Luedenscheid, Germany, 58515
        • Kreiskrankenhaus Luedenscheid
      • Mannheim, Germany, D-68135
        • Klinikum der Stadt Mannheim
      • Marburg, Germany, D-35033
        • University of Marburg
      • Muenster, Germany, D-48129
        • Klinik und Poliklinik fuer Kinderheilkunde
      • Munich, Germany, D-81675
        • Klinikum Rechts der Isar - Technische Universitaet Muenchen
      • Neubrandenburg, Germany, 17036
        • Klinikum Neubrandenburg
      • Nuernberg, Germany, D-90419
        • Klinikum Nuernberg - Klinikum Nord
      • Ostfildern, Germany, 73760
        • Paracelsus Karankenhaus Ruit
      • Pasewalk, Germany, 17309
        • Asklepios Klinik Pasewalk
      • Rotenburg, Germany, DOH-27356
        • Diakonie - Krankenhaus
      • Stendal, Germany, 39576
        • Johanniter Kankenhaus Stendal
      • Stuttgart, Germany, D-70174
        • Katharinenhospital
      • Tuebingen, Germany, D-72076
        • Universitaetsklinikum Tuebingen
      • Ulm, Germany, D-89075
        • Universitaet Ulm
      • Wolfsburg, Germany, D-38440
        • Klinikum der Stadt Wolfsburg
      • Wuppertal, Germany, D-42283
        • Klinikum St. Marien
      • Wuppertal, Germany, D-42283
        • Witten University - Klinikum Wuppertal
  • Hungary
      • Budapest, Hungary, 1125
        • National Institute of Oncology
  • Israel
      • Petah-Tikva, Israel, 49100
        • Rabin Medical Center - Beilinson Campus
      • Zerifin, Israel, 70300
        • Assaf Harofeh Medical Center
  • Italy
      • Cuneo, Italy, 12100
        • Ospedale Santa Croce
      • Milano, Italy, 20132
        • Istituto Scientifico H.San Raffaele
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
      • NL'S Hertogenbosch, Netherlands, NL-5211
        • Jeroen Bosch Ziekenhuis
      • Rotterdam, Netherlands, 3008 AE
        • Daniel Den Hoed Cancer Center at Erasmus Medical Center
      • Utrecht, Netherlands, 3584 CX
        • Academisch Ziekenhuis Utrecht
      • Utrecht, Netherlands, 3584 CX
        • University Hospital - Rotterdam Dijkzigt
  • Poland
      • Warsaw, Poland, 02-781
        • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
  • Slovakia
      • Bratislava, Slovakia, 833 10
        • National Cancer Institute - Bratislava
  • Spain
      • Badalona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol
      • Barcelona, Spain, 08003
        • Hospital Del Mar
      • Barcelona, Spain, 08036
        • Hospital Clinic y Provincial de Barcelona
      • Barcelona, Spain, 08036
        • Hospital General Universitari Vall d'Hebron
      • Coruna, Spain, 15006
        • Hospital Juan Canalejo
      • Guadalajara, Spain, 19002
        • Hospital General Universitario de Guadalajara
      • Jaen, Spain, E-23006
        • Hospital Cuidad de Jaen
      • La Coruna, Spain, 15405
        • Hospital Arquitecto Marcide
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28040
        • Hospital Universitario San Carlos
      • Malaga, Spain, 29010
        • Hospital Clinico Universitario - Malaga
      • Palma De Mallorca, Spain, 07014
        • Hospital Son Dureta
      • Sabadell, Spain, 08208
        • Hospsital de Sabadell
      • Santander, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
      • Terrassa, Spain, 08227
        • Hospital Consorci Sanitari De Terrassa
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
      • Valencia, Spain, 46009
        • Instituto Valenciano de Oncología
      • Valladolid, Spain, 47010
        • Hospital Rio Hortega
      • Vic, Spain, 08500
        • Hospital General de Vic
      • Zaragoza, Spain, 50009
        • Hospital Clinico Universitario
  • United Kingdom
    • England
      • Hull, England, United Kingdom, HU8 9HE
        • Princess Royal Hospital
      • Leeds, England, United Kingdom, LS9 7TF
        • St. James's University Hospital
      • London, England, United Kingdom, EC1A 7BE
        • Saint Bartholomew's Hospital
      • London, England, United Kingdom, SE1 9RT
        • Guy's and St. Thomas' Hospitals NHS Trust
      • Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
        • Northern Centre for Cancer Treatment at Newcastle General Hospital
      • Southampton, England, United Kingdom, SO14 0YG
        • Royal South Hants Hospital
      • Sutton, England, United Kingdom, SM2 5PT
        • Royal Marsden Hospital - Sutton
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 2TL
        • Velindre Cancer Center at Velinde Hospital
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85723
        • Veterans Affairs Medical Center - Tucson
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center at University of Arizona Health Sciences Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Veterans Affairs Medical Center - Little Rock (McClellan)
    • California
      • Duarte, California, United States, 91010-3000
        • City of Hope Comprehensive Cancer Center
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
      • Los Angeles, California, United States, 90033
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Martinez, California, United States, 94553
        • Veterans Affairs Outpatient Clinic - Martinez
      • Orange, California, United States, 92868
        • Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
      • Sacramento, California, United States, 95817
        • University of California Davis Cancer Center
    • Colorado
      • Aurora, Colorado, United States, 80010
        • University of Colorado Cancer Center at University of Colorado Health Sciences Center
    • Illinois
      • Hines, Illinois, United States, 60141
        • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
      • Maywood, Illinois, United States, 60153-5500
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
    • Kansas
      • Kansas City, Kansas, United States, 66160-7390
        • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
    • Kentucky
      • Lexington, Kentucky, United States, 40502-2236
        • Veterans Affairs Medical Center - Lexington
      • Lexington, Kentucky, United States, 40536-0084
        • Markey Cancer Center at University of Kentucky Chandler Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University School of Medicine
      • New Orleans, Louisiana, United States, 70112
        • Veterans Affairs Medical Center - New Orleans
      • Shreveport, Louisiana, United States, 71130-3932
        • Louisiana State University Health Sciences Center - Shreveport
      • Shreveport, Louisiana, United States, 71130
        • Veterans Affairs Medical Center - Shreveport
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Cancer Research Center at Boston Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Veterans Affairs Medical Center - Ann Arbor
      • Ann Arbor, Michigan, United States, 48109-0330
        • University of Michigan Comprehensive Cancer Center
      • Detroit, Michigan, United States, 48202
        • Josephine Ford Cancer Center at Henry Ford Hospital
      • Detroit, Michigan, United States, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Southfield, Michigan, United States, 48075
        • Providence Cancer Institute at Providence Hospital
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • St. Mary's - Duluth Clinic Cancer Center
    • Mississippi
      • Biloxi, Mississippi, United States, 39531-2410
        • Veterans Affairs Medical Center - Biloxi
      • Jackson, Mississippi, United States, 39216-4505
        • University of Mississippi Medical Center
      • Jackson, Mississippi, United States, 39216
        • Veterans Affairs Medical Center - Jackson
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Veterans Affairs Medical Center - Kansas City
      • Kansas City, Missouri, United States, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, United States, 63110
        • St. Louis University Hospital Cancer Center
    • New York
      • New York, New York, United States, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University
      • Rochester, New York, United States, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45220-2288
        • Veterans Affairs Medical Center - Cincinnati
      • Cincinnati, Ohio, United States, 45267-0501
        • Charles M. Barrett Cancer Center at University Hospital
      • Cleveland, Ohio, United States, 44195-9001
        • Cleveland Clinic Taussig Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Veterans Affairs Medical Center - Oklahoma City
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Medical Center at University of Oklahoma Health Sciences Center
    • Oregon
      • Portland, Oregon, United States, 97207
        • Veterans Affairs Medical Center - Portland
      • Portland, Oregon, United States, 97201-3098
        • Cancer Institute at Oregon Health and Science University
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Hollings Cancer Center at Medical University of South Carolina
      • Charleston, South Carolina, United States, 29401-5799
        • Veterans Affairs Medical Center - Charleston
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Veterans Affairs Medical Center - Memphis
      • Memphis, Tennessee, United States, 38103
        • University of Tennessee Cancer Institute
    • Texas
      • Amarillo, Texas, United States, 79106
        • Harrington Cancer Center
      • Amarillo, Texas, United States, 79106
        • Veterans Affairs Medical Center - Amarillo
      • Del Rio, Texas, United States, 78840
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
      • Fort Sam Houston, Texas, United States, 78234-6200
        • Brooke Army Medical Center
      • Galveston, Texas, United States, 77555-0565
        • University of Texas Medical Branch
      • Houston, Texas, United States, 77030-4095
        • University of Texas - MD Anderson Cancer Center
      • Lubbock, Texas, United States, 79415-3364
        • Southwest Cancer and Research Center at University Medical Center
      • San Antonio, Texas, United States, 78229-3900
        • University of Texas Health Science Center at San Antonio
      • San Antonio, Texas, United States, 78229
        • Veterans Affairs Medical Center - San Antonio (Murphy)
    • Utah
      • Salt Lake City, Utah, United States, 84148
        • Veterans Affairs Medical Center - Salt Lake City
      • Salt Lake City, Utah, United States, 84112-5550
        • Huntsman Cancer Institute
    • Washington
      • Seattle, Washington, United States, 98108
        • Veterans Affairs Medical Center - Seattle
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Collaborators

National Cancer Institute (NCI)
Medical Research Council
NCIC Clinical Trials Group
Institute of Cancer Research, United Kingdom
Southwest Oncology Group
Spanish Oncology Genito-Urinary Group
Groupe D'Etude des Tumeurs Uro-Genitales
Central European Cooperative Oncology Group
German Association of Urologic Oncology

Investigators

  • Study Chair: Joaquim Bellmunt, MD, PhD, Vall D'Hebron University Hospital
  • Study Chair: Stephane Culine, MD, Institut du Cancer de Montpellier - Val d'Aurelle
  • Study Chair: Michael Leahy, MBChB, FRACP, FRCP, FRC Path, Fremantle Hospital
  • Study Chair: Christoph Zielinski, MD, Allgemeines Krankenhaus - Universitatskliniken
  • Study Chair: David C. Smith, MD, University of Michigan Rogel Cancer Center
  • Study Chair: Andreas Boehle, MD, Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
  • Study Chair: Jose Baselga, MD, Vall D'Hebron University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2001

Primary Completion (Actual)

June 1, 2004

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

August 10, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

June 12, 2013

Last Update Submitted That Met QC Criteria

June 11, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-30987
  • CAN-NCIC-BL7
  • CECOG-EORTC-30987
  • GAUO-EORTC-30987
  • GETUG-EORTC-30987
  • SOGUG-EORTC-30987
  • SWOG-30987
  • NCRI-CRUK-BA11
  • MRC-BA11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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