Larotaxel + Cisplatin Versus Gemcitabine + Cisplatin in First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer
NCT ID: NCT00625664
Last Updated: 2016-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
337 participants
INTERVENTIONAL
2008-02-29
2011-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
larotaxel (XRP9881)
administered on day 1 as a 1-hour infusion
cisplatin
1 hour infusion administered on day 1, 30 minutes after the other treatment
2
gemcitabine
administered on day 1, 8 and 15 as a 30-minute infusion
cisplatin
1 hour infusion administered on day 1, 30 minutes after the other treatment
Interventions
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larotaxel (XRP9881)
administered on day 1 as a 1-hour infusion
gemcitabine
administered on day 1, 8 and 15 as a 30-minute infusion
cisplatin
1 hour infusion administered on day 1, 30 minutes after the other treatment
Eligibility Criteria
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Inclusion Criteria
* ECOG Performance Status 0 or 1
* No prior palliative chemotherapy
Exclusion Criteria
* Less than 6 weeks elapsed from prior radiotherapy and less than 3 weeks from surgery to time of randomization
* Prior cisplatin as (neo)adjuvant chemotherapy with cumulative dose \> 300 mg/m²
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Investigational Site Number 840068
Anchorage, Alaska, United States
Sanofi-Aventis Investigational Site Number 840035
Berkeley, California, United States
Sanofi-Aventis Investigational Site Number 840012
Burbank, California, United States
Sanofi-Aventis Investigational Site Number 840029
La Jolla, California, United States
Sanofi-Aventis Investigational Site Number 840046
Los Angeles, California, United States
Sanofi-Aventis Investigational Site Number 840003
Sacramento, California, United States
Sanofi-Aventis Investigational Site Number 840005
San Bernardino, California, United States
Sanofi-Aventis Investigational Site Number 840033
San Diego, California, United States
Sanofi-Aventis Investigational Site Number 840031
Denver, Colorado, United States
Sanofi-Aventis Investigational Site Number 840032
Stamford, Connecticut, United States
Sanofi-Aventis Investigational Site Number 840034
Washington D.C., District of Columbia, United States
Sanofi-Aventis Investigational Site Number 840021
Washington D.C., District of Columbia, United States
Sanofi-Aventis Investigational Site Number 840001
Boca Raton, Florida, United States
Sanofi-Aventis Investigational Site Number 840048
Boynton Beach, Florida, United States
Sanofi-Aventis Investigational Site Number 840049
Jacksonville, Florida, United States
Sanofi-Aventis Investigational Site Number 840061
Lakeland, Florida, United States
Sanofi-Aventis Investigational Site Number 840060
Athens, Georgia, United States
Sanofi-Aventis Investigational Site Number 840030
Boise, Idaho, United States
Sanofi-Aventis Investigational Site Number 840024
Maywood, Illinois, United States
Sanofi-Aventis Investigational Site Number 840062
Peoria, Illinois, United States
Sanofi-Aventis Investigational Site Number 840039
Goshen, Indiana, United States
Sanofi-Aventis Investigational Site Number 840054
Kansas City, Kansas, United States
Sanofi-Aventis Investigational Site Number 840057
Paducah, Kentucky, United States
Sanofi-Aventis Investigational Site Number 840004
Metarie, Louisiana, United States
Sanofi-Aventis Investigational Site Number 840045
Baltimore, Maryland, United States
Sanofi-Aventis Investigational Site Number 840006
Detroit, Michigan, United States
Sanofi-Aventis Investigational Site Number 840026
Lansing, Michigan, United States
Sanofi-Aventis Investigational Site Number 840047
Saint Joseph, Michigan, United States
Sanofi-Aventis Investigational Site Number 840009
Hackensack, New Jersey, United States
Sanofi-Aventis Investigational Site Number 840044
Lake Success, New York, United States
Sanofi-Aventis Investigational Site Number 840013
New York, New York, United States
Sanofi-Aventis Investigational Site Number 840050
New York, New York, United States
Sanofi-Aventis Investigational Site Number 840056
Rochester, New York, United States
Sanofi-Aventis Investigational Site Number 840015
Syracuse, New York, United States
Sanofi-Aventis Investigational Site Number 840041
Chapel Hill, North Carolina, United States
Sanofi-Aventis Investigational Site Number 840007
Charlotte, North Carolina, United States
Sanofi-Aventis Investigational Site Number 840019
Sylvania, Ohio, United States
Sanofi-Aventis Investigational Site Number 840020
Bethlehem, Pennsylvania, United States
Sanofi-Aventis Investigational Site Number 840065
Dunmore, Pennsylvania, United States
Sanofi-Aventis Investigational Site Number 840058
Woonsocket, Rhode Island, United States
Sanofi-Aventis Investigational Site Number 840052
Charleston, South Carolina, United States
Sanofi-Aventis Investigational Site Number 840002
Knoxville, Tennessee, United States
Sanofi-Aventis Investigational Site Number 840008
Houston, Texas, United States
Sanofi-Aventis Investigational Site Number 840018
Houston, Texas, United States
Sanofi-Aventis Investigational Site Number 840017
Lubbock, Texas, United States
Sanofi-Aventis Investigational Site Number 840016
San Antonio, Texas, United States
Sanofi-Aventis Investigational Site Number 840064
Temple, Texas, United States
Sanofi-Aventis Investigational Site Number 840010
The Woodlands, Texas, United States
Sanofi-Aventis Investigational Site Number 840036
Seattle, Washington, United States
Sanofi-Aventis Investigational Site Number 840011
Madison, Wisconsin, United States
Sanofi-Aventis Investigational Site Number 840025
Marshfield, Wisconsin, United States
Sanofi-Aventis Investigational Site Number 840038
Milwaukee, Wisconsin, United States
Sanofi-Aventis Investigational Site Number 032002
Buenos Aires, , Argentina
Sanofi-Aventis Investigational Site Number 032003
Ciudad de Buenos Aires, , Argentina
Sanofi-Aventis Investigational Site Number 032004
Mendoza, , Argentina
Sanofi-Aventis Investigational Site Number 032005
Rosario, , Argentina
Sanofi-Aventis Investigational Site Number 032001
Santa Fe, , Argentina
Sanofi-Aventis Investigational Site Number 036002
Adelaide, , Australia
Sanofi-Aventis Investigational Site Number 036003
Bedford Park, , Australia
Sanofi-Aventis Investigational Site Number 036004
St Leonards, , Australia
Sanofi-Aventis Investigational Site Number 056005
Aalst, , Belgium
Sanofi-Aventis Investigational Site Number 056001
Brussels, , Belgium
Sanofi-Aventis Investigational Site Number 056002
Brussels, , Belgium
Sanofi-Aventis Investigational Site Number 056004
Ottignies, , Belgium
Sanofi-Aventis Investigational Site Number 056003
Wilrijk, , Belgium
Sanofi-Aventis Investigational Site Number 056006
Yvoir, , Belgium
Sanofi-Aventis Investigational Site Number 076006
Barretos, , Brazil
Sanofi-Aventis Investigational Site Number 076004
Florianópolis, , Brazil
Sanofi-Aventis Investigational Site Number 076001
Porto Alegre, , Brazil
Sanofi-Aventis Investigational Site Number 076003
Porto Alegre, , Brazil
Sanofi-Aventis Investigational Site Number 076002
Rio de Janeiro, , Brazil
Sanofi-Aventis Investigational Site Number 076007
São Paulo, , Brazil
Sanofi-Aventis Investigational Site Number 076005
São Paulo, , Brazil
Sanofi-Aventis Investigational Site Number 124007
Edmonton, , Canada
Sanofi-Aventis Investigational Site Number 124001
London, , Canada
Sanofi-Aventis Investigational Site Number 124006
Montreal, , Canada
Sanofi-Aventis Investigational Site Number 124003
Québec, , Canada
Sanofi-Aventis Investigational Site Number 124002
Weston, , Canada
Sanofi-Aventis Investigational Site Number 152001
Santiago, , Chile
Sanofi-Aventis Investigational Site Number 250006
Avignon, , France
Sanofi-Aventis Investigational Site Number 250003
Bordeaux, , France
Sanofi-Aventis Investigational Site Number 250005
Hyères, , France
Sanofi-Aventis Investigational Site Number 250011
Le Mans, , France
Sanofi-Aventis Investigational Site Number 250004
Lyon, , France
Sanofi-Aventis Investigational Site Number 250012
Perpignan, , France
Sanofi-Aventis Investigational Site Number 250007
Poitiers, , France
Sanofi-Aventis Investigational Site Number 250008
Saint-Herblain, , France
Sanofi-Aventis Investigational Site Number 250009
Strasbourg, , France
Sanofi-Aventis Investigational Site Number 250001
Suresnes, , France
Sanofi-Aventis Investigational Site Number 356003
Bangalore, , India
Sanofi-Aventis Investigational Site Number 356007
Kolkata, , India
Sanofi-Aventis Investigational Site Number 356004
New Delhi, , India
Sanofi-Aventis Investigational Site Number 356001
New Delhi, , India
Sanofi-Aventis Investigational Site Number 356002
Vellore, , India
Sanofi-Aventis Investigational Site Number 356005
Visakhapatnam, , India
Sanofi-Aventis Investigational Site Number 376005
Haifa, , Israel
Sanofi-Aventis Investigational Site Number 376004
Kfar Saba, , Israel
Sanofi-Aventis Investigational Site Number 376003
Petah Tikva, , Israel
Sanofi-Aventis Investigational Site Number 376002
Tel Aviv, , Israel
Sanofi-Aventis Investigational Site Number 376007
Tel Litwinsky, , Israel
Sanofi-Aventis Investigational Site Number 376001
Tzrifin, , Israel
Sanofi-Aventis Investigational Site Number 380004
Bari, , Italy
Sanofi-Aventis Investigational Site Number 380003
Lecce, , Italy
Sanofi-Aventis Investigational Site Number 380005
Meldola, , Italy
Sanofi-Aventis Investigational Site Number 380006
Pavia, , Italy
Sanofi-Aventis Investigational Site Number 380002
Perugia, , Italy
Sanofi-Aventis Investigational Site Number 380001
Roma, , Italy
Sanofi-Aventis Investigational Site Number 380008
Viterbo, , Italy
Sanofi-Aventis Investigational Site Number 484003
Aguascalientes, , Mexico
Sanofi-Aventis Investigational Site Number 484007
Chihuahua City, , Mexico
Sanofi-Aventis Investigational Site Number 484005
Chihuahua City, , Mexico
Sanofi-Aventis Investigational Site Number 484004
Monterrey, , Mexico
Sanofi-Aventis Investigational Site Number 528005
Amsterdam, , Netherlands
Sanofi-Aventis Investigational Site Number 528002
Arnhem, , Netherlands
Sanofi-Aventis Investigational Site Number 528006
Hoofddorp, , Netherlands
Sanofi-Aventis Investigational Site Number 528003
Maastricht, , Netherlands
Sanofi-Aventis Investigational Site Number 528004
Nijmegen, , Netherlands
Sanofi-Aventis Investigational Site Number 528001
Sittard-Geleen, , Netherlands
Sanofi-Aventis Investigational Site Number 528007
Zwolle, , Netherlands
Sanofi-Aventis Investigational Site Number 616002
Poznan, , Poland
Sanofi-Aventis Investigational Site Number 616004
Rybnik, , Poland
Sanofi-Aventis Investigational Site Number 616001
Warsaw, , Poland
Sanofi-Aventis Investigational Site Number 616005
Wroclaw, , Poland
Sanofi-Aventis Investigational Site Number 643009
Chelyabinsk, , Russia
Sanofi-Aventis Investigational Site Number 643010
Kursk, , Russia
Sanofi-Aventis Investigational Site Number 643006
Moscow, , Russia
Sanofi-Aventis Investigational Site Number 643008
Moscow, , Russia
Sanofi-Aventis Investigational Site Number 643004
Moscow, , Russia
Sanofi-Aventis Investigational Site Number 643005
Moscow, , Russia
Sanofi-Aventis Investigational Site Number 643001
Obninsk, , Russia
Sanofi-Aventis Investigational Site Number 643002
Saint Petersburg, , Russia
Sanofi-Aventis Investigational Site Number 643003
Saint Petersburg, , Russia
Sanofi-Aventis Investigational Site Number 643007
Saint Petersburg, , Russia
Sanofi-Aventis Investigational Site Number 643011
Saint Petersburg, , Russia
Sanofi-Aventis Investigational Site Number 710008
Bloemfontein, , South Africa
Sanofi-Aventis Investigational Site Number 710003
Cape Town, , South Africa
Sanofi-Aventis Investigational Site Number 710001
Cape Town, , South Africa
Sanofi-Aventis Investigational Site Number 710007
Durban, , South Africa
Sanofi-Aventis Investigational Site Number 710009
Durban, , South Africa
Sanofi-Aventis Investigational Site Number 710006
Port Elizabeth, , South Africa
Sanofi-Aventis Investigational Site Number 710005
Pretoria, , South Africa
Sanofi-Aventis Investigational Site Number 724006
Badalona, , Spain
Sanofi-Aventis Investigational Site Number 724001
Barcelona, , Spain
Sanofi-Aventis Investigational Site Number 724004
Barcelona, , Spain
Sanofi-Aventis Investigational Site Number 724008
Barcelona, , Spain
Sanofi-Aventis Investigational Site Number 724002
Barcelona, , Spain
Sanofi-Aventis Investigational Site Number 724003
Madrid, , Spain
Sanofi-Aventis Investigational Site Number 724010
Oviedo, , Spain
Sanofi-Aventis Investigational Site Number 724013
Palma de Mallorca, , Spain
Sanofi-Aventis Investigational Site Number 724007
Palma de Mallorca, , Spain
Sanofi-Aventis Investigational Site Number 724009
Pamplona, , Spain
Sanofi-Aventis Investigational Site Number 724011
Santiago de Compostela, , Spain
Sanofi-Aventis Investigational Site Number 724012
Zaragoza, , Spain
Sanofi-Aventis Investigational Site Number 752001
Umeå, , Sweden
Sanofi-Aventis Investigational Site Number 752002
Uppsala, , Sweden
Sanofi-Aventis Investigational Site Number 792002
Ankara, , Turkey (Türkiye)
Sanofi-Aventis Investigational Site Number 792003
Ankara, , Turkey (Türkiye)
Sanofi-Aventis Investigational Site Number 792004
Ankara, , Turkey (Türkiye)
Sanofi-Aventis Investigational Site Number 792006
Istanbul, , Turkey (Türkiye)
Sanofi-Aventis Investigational Site Number 792001
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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EUDRACT: 2007-001943-23
Identifier Type: -
Identifier Source: secondary_id
EFC6668
Identifier Type: -
Identifier Source: org_study_id
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