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Cisplatin Plus Gemcitabine With or Without Paclitaxel in Treating Patients With Stage IV Urinary Tract Cancer
This study is ongoing, but not recruiting participants.
First Received: August 10, 2001   Last Updated: July 23, 2008   History of Changes
Sponsor: European Organization for Research and Treatment of Cancer
Collaborators: National Cancer Institute (NCI)
Groupe D'Etude des Tumeurs Uro-Genitales
Institute of Cancer Research, United Kingdom
Central European Cooperative Oncology Group
NCIC Clinical Trials Group
Southwest Oncology Group
German Association of Urologic Oncology
Spanish Oncology Genito-Urinary Group
Medical Research Council
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00022191
  Purpose

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.


Condition Intervention Phase
Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Urethral Cancer
Drug: cisplatin
Drug: gemcitabine hydrochloride
Drug: paclitaxel
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 2001
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00022191

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

Additional Information:
Publications:
Bellmunt J, von der Maase H, Mead GM, et al.: Randomized phase III study comparing paclitaxel/cisplatin/gemcitabine (PCG) and gemcitabine/cisplatin (GC) in patients with locally advanced (LA) or metastatic (M) urothelial cancer without prior systemic therapy: EORTC30987/Intergroup study. [Abstract] J Clin Oncol 25 (Suppl 18): A-LBA5030, 242s, 2007.

Study ID Numbers: CDR0000068793, EORTC-30987, CAN-NCIC-BL7, CECOG-EORTC-30987, GAUO-EORTC-30987, GETUG-EORTC-30987, SOGUG-EORTC-30987, SWOG-30987, NCRI-CRUK-BA11, MRC-BA11
Study First Received: August 10, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00022191     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
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
Cisplatin
Kidney Neoplasms
Therapeutic Uses
Urethral Diseases
Kidney Diseases
Gemcitabine
Neoplasms by Histologic Type
Mitosis Modulators
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Enzyme Inhibitors
Antimitotic Agents
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Carcinoma
Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009