Larotaxel + Cisplatin Versus Gemcitabine + Cisplatin in First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer
- Conditions
- Urinary Bladder Neoplasms
- Interventions
- Registration Number
- NCT00625664
- Lead Sponsor
- Sanofi
- Brief Summary
This is a randomized, open-label, multi-center study comparing the efficacy and safety of XRP9881 plus cisplatin to gemcitabine plus cisplatin in the first line treatment of locally advanced/metastatic urothelial tract or bladder cancer. The primary objective is to compare overall survival. Secondary objectives include comparisons of progression free survival, objective response rate, time to definitive deterioration of performance status, duration of response, time to definitive weight loss, and assessments of overall safety, and pharmacokinetics. Patients are treated until disease progression, death, or unacceptable toxicity and are followed-up until death or the end of the study whichever comes first.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 337
- Patients with histology/cytology confirmed Transitional Cell Carcinoma (TCC) with locally advanced (T4b) or metastatic urothelial tract or bladder cancer
- ECOG Performance Status 0 or 1
- No prior palliative chemotherapy
- (Neo)Adjuvant chemotherapy if < 6 months between end of (neo)adjuvant chemotherapy and relapse
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 larotaxel (XRP9881) - 1 cisplatin - 2 gemcitabine - 2 cisplatin -
- Primary Outcome Measures
Name Time Method Overall survival defined as the time interval from the date of randomization to the date of death due to any cause study period
- Secondary Outcome Measures
Name Time Method Radiological tumor assessments (CT/MRI) at screening, every 8 weeks during treatment, at end of treatment, and in follow-up until documented disease progression Adverse Events, laboratory assessments, vital signs, Physical Examinations, and ECOG Performance Status at screening and every cycle
Trial Locations
- Locations (160)
Sanofi-Aventis Investigational Site Number 840033
🇺🇸San Diego, California, United States
Sanofi-Aventis Investigational Site Number 840036
🇺🇸Seattle, Washington, United States
Sanofi-Aventis Investigational Site Number 840020
🇺🇸Bethlehem, Pennsylvania, United States
Sanofi-Aventis Investigational Site Number 840018
🇺🇸Houston, Texas, United States
Sanofi-Aventis Investigational Site Number 076007
🇧🇷Sao Paulo, Brazil
Sanofi-Aventis Investigational Site Number 076005
🇧🇷Sao Paulo, Brazil
Sanofi-Aventis Investigational Site Number 124001
🇨🇦London, Canada
Sanofi-Aventis Investigational Site Number 124007
🇨🇦Edmonton, Canada
Sanofi-Aventis Investigational Site Number 643009
🇷🇺Chelyabinsk, Russian Federation
Sanofi-Aventis Investigational Site Number 710001
🇿🇦Cape Town, South Africa
Sanofi-Aventis Investigational Site Number 710006
🇿🇦Port Elizabeth, 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 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 724009
🇪🇸Pamplona, Spain
Sanofi-Aventis Investigational Site Number 724010
🇪🇸Oviedo, Spain
Sanofi-Aventis Investigational Site Number 724003
🇪🇸Madrid, Spain
Sanofi-Aventis Investigational Site Number 724002
🇪🇸Barcelona, 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 724011
🇪🇸Santiago De Compostela, Spain
Sanofi-Aventis Investigational Site Number 752001
🇸🇪Umeå, Sweden
Sanofi-Aventis Investigational Site Number 752002
🇸🇪Uppsala, Sweden
Sanofi-Aventis Investigational Site Number 792004
🇹🇷Ankara, Turkey
Sanofi-Aventis Investigational Site Number 792002
🇹🇷Ankara, Turkey
Sanofi-Aventis Investigational Site Number 792001
🇹🇷Istanbul, Turkey
Sanofi-Aventis Investigational Site Number 840054
🇺🇸Kansas City, Kansas, United States
Sanofi-Aventis Investigational Site Number 840032
🇺🇸Stamford, Connecticut, United States
Sanofi-Aventis Investigational Site Number 032001
🇦🇷Santa Fe, Argentina
Sanofi-Aventis Investigational Site Number 056004
🇧🇪Ottignies, Belgium
Sanofi-Aventis Investigational Site Number 484003
🇲🇽Aguascalientes, Mexico
Sanofi-Aventis Investigational Site Number 643011
🇷🇺St-Petersburg, Russian Federation
Sanofi-Aventis Investigational Site Number 792003
🇹🇷Ankara, Turkey
Sanofi-Aventis Investigational Site Number 840068
🇺🇸Anchorage, Alaska, United States
Sanofi-Aventis Investigational Site Number 643008
🇷🇺Moscow, Russian Federation
Sanofi-Aventis Investigational Site Number 356001
🇮🇳New Delhi, India
Sanofi-Aventis Investigational Site Number 643002
🇷🇺St-Petersburg, Russian Federation
Sanofi-Aventis Investigational Site Number 056001
🇧🇪Bruxelles, Belgium
Sanofi-Aventis Investigational Site Number 056003
🇧🇪Wilrijk, Belgium
Sanofi-Aventis Investigational Site Number 840026
🇺🇸Lansing, Michigan, United States
Sanofi-Aventis Investigational Site Number 032002
🇦🇷Buenos Aires, Argentina
Sanofi-Aventis Investigational Site Number 056002
🇧🇪Bruxelles, Belgium
Sanofi-Aventis Investigational Site Number 376005
🇮🇱Haifa, Israel
Sanofi-Aventis Investigational Site Number 376003
🇮🇱Petah-Tikva, Israel
Sanofi-Aventis Investigational Site Number 528002
🇳🇱Arnhem, Netherlands
Sanofi-Aventis Investigational Site Number 643003
🇷🇺Saint-Petersburg, Russian Federation
Sanofi-Aventis Investigational Site Number 840021
🇺🇸Washington, District of Columbia, United States
Sanofi-Aventis Investigational Site Number 032004
🇦🇷Mendoza, Argentina
Sanofi-Aventis Investigational Site Number 356005
🇮🇳Vishakhapatnam, India
Sanofi-Aventis Investigational Site Number 376001
🇮🇱Tzrifin, Israel
Sanofi-Aventis Investigational Site Number 484005
🇲🇽Chihuahua, Mexico
Sanofi-Aventis Investigational Site Number 528001
🇳🇱Sittard-Geleen, Netherlands
Sanofi-Aventis Investigational Site Number 616005
🇵🇱Wroclaw, Poland
Sanofi-Aventis Investigational Site Number 643001
🇷🇺Obninsk, Russian Federation
Sanofi-Aventis Investigational Site Number 643010
🇷🇺Kursk, Russian Federation
Sanofi-Aventis Investigational Site Number 792006
🇹🇷Istanbul, Turkey
Sanofi-Aventis Investigational Site Number 380004
🇮🇹Bari, Italy
Sanofi-Aventis Investigational Site Number 380003
🇮🇹Lecce, Italy
Sanofi-Aventis Investigational Site Number 380008
🇮🇹Viterbo, Italy
Sanofi-Aventis Investigational Site Number 710008
🇿🇦Bloemfontein, South Africa
Sanofi-Aventis Investigational Site Number 840031
🇺🇸Denver, Colorado, United States
Sanofi-Aventis Investigational Site Number 840038
🇺🇸Milwaukee, Wisconsin, United States
Sanofi-Aventis Investigational Site Number 840002
🇺🇸Knoxville, Tennessee, United States
Sanofi-Aventis Investigational Site Number 840046
🇺🇸Los Angeles, California, United States
Sanofi-Aventis Investigational Site Number 840030
🇺🇸Boise, Idaho, United States
Sanofi-Aventis Investigational Site Number 840047
🇺🇸St. Joseph, Michigan, United States
Sanofi-Aventis Investigational Site Number 840001
🇺🇸Boca Raton, Florida, United States
Sanofi-Aventis Investigational Site Number 840060
🇺🇸Athens, Georgia, United States
Sanofi-Aventis Investigational Site Number 840006
🇺🇸Detroit, Michigan, United States
Sanofi-Aventis Investigational Site Number 840034
🇺🇸Washington, District of Columbia, United States
Sanofi-Aventis Investigational Site Number 840045
🇺🇸Baltimore, Maryland, United States
Sanofi-Aventis Investigational Site Number 840004
🇺🇸Metarie, Louisiana, United States
Sanofi-Aventis Investigational Site Number 840013
🇺🇸New York, New York, 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 840058
🇺🇸Woonsocket, Rhode Island, United States
Sanofi-Aventis Investigational Site Number 840008
🇺🇸Houston, Texas, United States
Sanofi-Aventis Investigational Site Number 840025
🇺🇸Marshfield, Wisconsin, United States
Sanofi-Aventis Investigational Site Number 840064
🇺🇸Temple, Texas, United States
Sanofi-Aventis Investigational Site Number 840016
🇺🇸San Antonio, Texas, United States
Sanofi-Aventis Investigational Site Number 036004
🇦🇺St Leonards, Australia
Sanofi-Aventis Investigational Site Number 056005
🇧🇪Aalst, Belgium
Sanofi-Aventis Investigational Site Number 840017
🇺🇸Lubbock, Texas, United States
Sanofi-Aventis Investigational Site Number 032005
🇦🇷Rosario, Argentina
Sanofi-Aventis Investigational Site Number 076004
🇧🇷Florianopolis, Brazil
Sanofi-Aventis Investigational Site Number 840010
🇺🇸Woodlands, Texas, United States
Sanofi-Aventis Investigational Site Number 032003
🇦🇷Ciudad De Buenos Aires, Argentina
Sanofi-Aventis Investigational Site Number 036002
🇦🇺Adelaide, Australia
Sanofi-Aventis Investigational Site Number 124002
🇨🇦Weston, Canada
Sanofi-Aventis Investigational Site Number 124006
🇨🇦Montreal, Canada
Sanofi-Aventis Investigational Site Number 036003
🇦🇺Bedford Park, Australia
Sanofi-Aventis Investigational Site Number 056006
🇧🇪Yvoir, Belgium
Sanofi-Aventis Investigational Site Number 076006
🇧🇷Barretos, Brazil
Sanofi-Aventis Investigational Site Number 250005
🇫🇷Hyeres, France
Sanofi-Aventis Investigational Site Number 076001
🇧🇷Porto Alegre, Brazil
Sanofi-Aventis Investigational Site Number 250006
🇫🇷Avignon, France
Sanofi-Aventis Investigational Site Number 124003
🇨🇦Quebec, Canada
Sanofi-Aventis Investigational Site Number 076003
🇧🇷Porto Alegre, Brazil
Sanofi-Aventis Investigational Site Number 152001
🇨🇱Santiago, Chile
Sanofi-Aventis Investigational Site Number 250012
🇫🇷Perpignan, France
Sanofi-Aventis Investigational Site Number 076002
🇧🇷Rio De Janeiro, Brazil
Sanofi-Aventis Investigational Site Number 356003
🇮🇳Bangalore, India
Sanofi-Aventis Investigational Site Number 356004
🇮🇳New Delhi, India
Sanofi-Aventis Investigational Site Number 376004
🇮🇱Kfar Saba, Israel
Sanofi-Aventis Investigational Site Number 250003
🇫🇷Bordeaux Cedex, France
Sanofi-Aventis Investigational Site Number 250009
🇫🇷Strasbourg, France
Sanofi-Aventis Investigational Site Number 356007
🇮🇳Kolkata, India
Sanofi-Aventis Investigational Site Number 356002
🇮🇳Vellore, India
Sanofi-Aventis Investigational Site Number 250011
🇫🇷Le Mans, France
Sanofi-Aventis Investigational Site Number 250004
🇫🇷Lyon, France
Sanofi-Aventis Investigational Site Number 250007
🇫🇷Poitiers Cedex, France
Sanofi-Aventis Investigational Site Number 250008
🇫🇷Saint Herblain, France
Sanofi-Aventis Investigational Site Number 250001
🇫🇷Suresnes, France
Sanofi-Aventis Investigational Site Number 376002
🇮🇱Tel Aviv, Israel
Sanofi-Aventis Investigational Site Number 380002
🇮🇹Perugia, Italy
Sanofi-Aventis Investigational Site Number 376007
🇮🇱Tel Hashomer, Israel
Sanofi-Aventis Investigational Site Number 380005
🇮🇹Meldola, Italy
Sanofi-Aventis Investigational Site Number 380006
🇮🇹Pavia, Italy
Sanofi-Aventis Investigational Site Number 380001
🇮🇹Roma, Italy
Sanofi-Aventis Investigational Site Number 484007
🇲🇽Chihuahua, Mexico
Sanofi-Aventis Investigational Site Number 484004
🇲🇽Monterrey, Mexico
Sanofi-Aventis Investigational Site Number 528005
🇳🇱Amsterdam, Netherlands
Sanofi-Aventis Investigational Site Number 528006
🇳🇱Hoofddorp, Netherlands
Sanofi-Aventis Investigational Site Number 528004
🇳🇱Nijmegen, Netherlands
Sanofi-Aventis Investigational Site Number 616002
🇵🇱Poznan, Poland
Sanofi-Aventis Investigational Site Number 528003
🇳🇱Maastricht, Netherlands
Sanofi-Aventis Investigational Site Number 528007
🇳🇱Zwolle, Netherlands
Sanofi-Aventis Investigational Site Number 616004
🇵🇱Rybnik, Poland
Sanofi-Aventis Investigational Site Number 643004
🇷🇺Moscow, Russian Federation
Sanofi-Aventis Investigational Site Number 616001
🇵🇱Warszawa, Poland
Sanofi-Aventis Investigational Site Number 643005
🇷🇺Moscow, Russian Federation
Sanofi-Aventis Investigational Site Number 643007
🇷🇺Saint-Petersburg, Russian Federation
Sanofi-Aventis Investigational Site Number 710003
🇿🇦Cape Town, South Africa
Sanofi-Aventis Investigational Site Number 724012
🇪🇸Zaragoza, Spain
Sanofi-Aventis Investigational Site Number 724008
🇪🇸Barcelona, Spain
Sanofi-Aventis Investigational Site Number 840035
🇺🇸Berkeley, California, United States
Sanofi-Aventis Investigational Site Number 840029
🇺🇸La Jolla, California, United States
Sanofi-Aventis Investigational Site Number 840005
🇺🇸San Bernardino, California, United States
Sanofi-Aventis Investigational Site Number 840012
🇺🇸Burbank, California, United States
Sanofi-Aventis Investigational Site Number 840048
🇺🇸Boynton Beach, Florida, United States
Sanofi-Aventis Investigational Site Number 840024
🇺🇸Maywood, Illinois, United States
Sanofi-Aventis Investigational Site Number 840049
🇺🇸Jacksonville, Florida, United States
Sanofi-Aventis Investigational Site Number 840057
🇺🇸Paducah, Kentucky, 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 840044
🇺🇸Lake Success, New York, United States
Sanofi-Aventis Investigational Site Number 840056
🇺🇸Rochester, New York, United States
Sanofi-Aventis Investigational Site Number 840050
🇺🇸New York, New York, United States
Sanofi-Aventis Investigational Site Number 840015
🇺🇸Syracuse, New York, United States
Sanofi-Aventis Investigational Site Number 840065
🇺🇸Dunmore, Pennsylvania, United States
Sanofi-Aventis Investigational Site Number 840003
🇺🇸Sacramento, California, United States
Sanofi-Aventis Investigational Site Number 840009
🇺🇸Hackensack, New Jersey, United States
Sanofi-Aventis Investigational Site Number 840041
🇺🇸Chapel Hill, North Carolina, United States
Sanofi-Aventis Investigational Site Number 840052
🇺🇸Charleston, South Carolina, United States
Sanofi-Aventis Investigational Site Number 840011
🇺🇸Madison, Wisconsin, United States
Sanofi-Aventis Investigational Site Number 840061
🇺🇸Lakeland, Florida, United States
Sanofi-Aventis Investigational Site Number 643006
🇷🇺Moscow, Russian Federation