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 chemotherapyregimen is more effective for urinary tract cancer.

PURPOSE: Randomizedphase 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	Treatment or Intervention	Phase
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	Drug: cisplatin  Drug: gemcitabine  Drug: paclitaxel  Procedure: chemotherapy	Phase III

Further Study Details: 

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.

PROJECTED ACCRUAL: A total of 610 patients (305 per treatment arm) will be accrued for this study within 3.04 years.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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)

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

Study chairs or principal investigators

Joaquim Bellmunt, MD, PhD,  Study Chair,  Hospital General Universitari Vall d'Hebron   
Stephane Culine, MD,  Study Chair,  Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle   
Michael Leahy, MBChB, FRACP, FRCP, FRC PATH,  Study Chair,  Fremantle Hospital   
Christoph Zielinski, MD,  Study Chair,  Allgemeines Krankenhaus der Stadt Wien   
Malcolm J. Moore, MD,  Study Chair,  Ontario Cancer Institute   
David C. Smith, MD,  Study Chair,  University of Michigan Comprehensive Cancer Center   
Andreas Boehle, MD,  Study Chair,  Medizinische Universitaet Luebeck   
Jose Baselga, MD,  Study Chair,  Hospital General Universitari Vall d'Hebron   
Michael Leahy, MBChB, FRACP, FRCP, FRC PATH,  Study Chair,  Fremantle Hospital   
Donald S. Kaufman, MD,  Massachusetts General Hospital   

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; RTOG-EORTC-30987
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  August 10, 2001
ClinicalTrials.gov Identifier:  NCT00022191
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08