Clinical trial NCT00625664: Larotaxel + Cisplatin Versus Gemcitabine + Cisplatin in First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer
Official title: Randomized Study of LAROTAXEL + Cisplatin (LC) vs. Gemcitabine + Cisplatin (GC) in the First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Bladder Neoplasms
Keywords: Cancer
Neoplasms
Bladder
Urothelial Tract
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-02-28
Enrollment: 337
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* (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.

Primary outcomes:
measure: Overall survival defined as the time interval from the date of randomization to the date of death due to any cause
timeFrame: study period
Secondary outcomes:
measure: Radiological tumor assessments (CT/MRI)
timeFrame: at screening, every 8 weeks during treatment, at end of treatment, and in follow-up until documented disease progression
measure: Adverse Events, laboratory assessments, vital signs, Physical Examinations, and ECOG Performance Status
timeFrame: at screening and every cycle
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Sanofi-Aventis Investigational Site Number 840068
state: Alaska
city: Berkeley
country: United States
facility: Sanofi-Aventis Investigational Site Number 840035
state: California
city: Burbank
country: United States
facility: Sanofi-Aventis Investigational Site Number 840012
state: California
city: La Jolla
country: United States
facility: Sanofi-Aventis Investigational Site Number 840029
state: California
city: Los Angeles
country: United States
facility: Sanofi-Aventis Investigational Site Number 840046
state: California
city: Sacramento
country: United States
facility: Sanofi-Aventis Investigational Site Number 840003
state: California
city: San Bernardino
country: United States
facility: Sanofi-Aventis Investigational Site Number 840005
state: California
city: San Diego
country: United States
facility: Sanofi-Aventis Investigational Site Number 840033
state: California
city: Denver
country: United States
facility: Sanofi-Aventis Investigational Site Number 840031
state: Colorado
city: Stamford
country: United States
facility: Sanofi-Aventis Investigational Site Number 840032
state: Connecticut
city: Washington
country: United States
facility: Sanofi-Aventis Investigational Site Number 840034
state: District of Columbia
city: Washington
country: United States
facility: Sanofi-Aventis Investigational Site Number 840021
state: District of Columbia
city: Boca Raton
country: United States
facility: Sanofi-Aventis Investigational Site Number 840001
state: Florida
city: Boynton Beach
country: United States
facility: Sanofi-Aventis Investigational Site Number 840048
state: Florida
city: Jacksonville
country: United States
facility: Sanofi-Aventis Investigational Site Number 840049
state: Florida
city: Lakeland
country: United States
facility: Sanofi-Aventis Investigational Site Number 840061
state: Florida
city: Athens
country: United States
facility: Sanofi-Aventis Investigational Site Number 840060
state: Georgia
city: Boise
country: United States
facility: Sanofi-Aventis Investigational Site Number 840030
state: Idaho
city: Maywood
country: United States
facility: Sanofi-Aventis Investigational Site Number 840024
state: Illinois
city: Peoria
country: United States
facility: Sanofi-Aventis Investigational Site Number 840062
state: Illinois
city: Goshen
country: United States
facility: Sanofi-Aventis Investigational Site Number 840039
state: Indiana
city: Kansas City
country: United States
facility: Sanofi-Aventis Investigational Site Number 840054
state: Kansas
city: Paducah
country: United States
facility: Sanofi-Aventis Investigational Site Number 840057
state: Kentucky
city: Metarie
country: United States
facility: Sanofi-Aventis Investigational Site Number 840004
state: Louisiana
city: Baltimore
country: United States
facility: Sanofi-Aventis Investigational Site Number 840045
state: Maryland
city: Detroit
country: United States
facility: Sanofi-Aventis Investigational Site Number 840006
state: Michigan
city: Lansing
country: United States
facility: Sanofi-Aventis Investigational Site Number 840026
state: Michigan
city: St. Joseph
country: United States
facility: Sanofi-Aventis Investigational Site Number 840047
state: Michigan
city: Hackensack
country: United States
facility: Sanofi-Aventis Investigational Site Number 840009
state: New Jersey
city: Lake Success
country: United States
facility: Sanofi-Aventis Investigational Site Number 840044
state: New York
city: New York
country: United States
facility: Sanofi-Aventis Investigational Site Number 840013
state: New York
city: New York
country: United States
facility: Sanofi-Aventis Investigational Site Number 840050
state: New York
city: Rochester
country: United States
facility: Sanofi-Aventis Investigational Site Number 840056
state: New York
city: Syracuse
country: United States
facility: Sanofi-Aventis Investigational Site Number 840015
state: New York
city: Chapel Hill
country: United States
facility: Sanofi-Aventis Investigational Site Number 840041
state: North Carolina
city: Charlotte
country: United States
facility: Sanofi-Aventis Investigational Site Number 840007
state: North Carolina
city: Sylvania
country: United States
facility: Sanofi-Aventis Investigational Site Number 840019
state: Ohio
city: Bethlehem
country: United States
facility: Sanofi-Aventis Investigational Site Number 840020
state: Pennsylvania
city: Dunmore
country: United States
facility: Sanofi-Aventis Investigational Site Number 840065
state: Pennsylvania
city: Woonsocket
country: United States
facility: Sanofi-Aventis Investigational Site Number 840058
state: Rhode Island
city: Charleston
country: United States
facility: Sanofi-Aventis Investigational Site Number 840052
state: South Carolina
city: Knoxville
country: United States
facility: Sanofi-Aventis Investigational Site Number 840002
state: Tennessee
city: Houston
country: United States
facility: Sanofi-Aventis Investigational Site Number 840008
state: Texas
city: Houston
country: United States
facility: Sanofi-Aventis Investigational Site Number 840018
state: Texas
city: Lubbock
country: United States
facility: Sanofi-Aventis Investigational Site Number 840017
state: Texas
city: San Antonio
country: United States
facility: Sanofi-Aventis Investigational Site Number 840016
state: Texas
city: Temple
country: United States
facility: Sanofi-Aventis Investigational Site Number 840064
state: Texas
city: Woodlands
country: United States
facility: Sanofi-Aventis Investigational Site Number 840010
state: Texas
city: Seattle
country: United States
facility: Sanofi-Aventis Investigational Site Number 840036
state: Washington
city: Madison
country: United States
facility: Sanofi-Aventis Investigational Site Number 840011
state: Wisconsin
city: Marshfield
country: United States
facility: Sanofi-Aventis Investigational Site Number 840025
state: Wisconsin
city: Milwaukee
country: United States
facility: Sanofi-Aventis Investigational Site Number 840038
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Sanofi-Aventis Investigational Site Number 032002
city: Ciudad De Buenos Aires
country: Argentina
facility: Sanofi-Aventis Investigational Site Number 032003
city: Mendoza
country: Argentina
facility: Sanofi-Aventis Investigational Site Number 032004
city: Rosario
country: Argentina
facility: Sanofi-Aventis Investigational Site Number 032005
city: Santa Fe
country: Argentina
facility: Sanofi-Aventis Investigational Site Number 032001
city: Adelaide
country: Australia
facility: Sanofi-Aventis Investigational Site Number 036002
city: Bedford Park
country: Australia
facility: Sanofi-Aventis Investigational Site Number 036003
city: St Leonards
country: Australia
facility: Sanofi-Aventis Investigational Site Number 036004
city: Aalst
country: Belgium
facility: Sanofi-Aventis Investigational Site Number 056005
city: Bruxelles
country: Belgium
facility: Sanofi-Aventis Investigational Site Number 056001
city: Bruxelles
country: Belgium
facility: Sanofi-Aventis Investigational Site Number 056002
city: Ottignies
country: Belgium
facility: Sanofi-Aventis Investigational Site Number 056004
city: Wilrijk
country: Belgium
facility: Sanofi-Aventis Investigational Site Number 056003
city: Yvoir
country: Belgium
facility: Sanofi-Aventis Investigational Site Number 056006
city: Barretos
country: Brazil
facility: Sanofi-Aventis Investigational Site Number 076006
city: Florianopolis
country: Brazil
facility: Sanofi-Aventis Investigational Site Number 076004
city: Porto Alegre
country: Brazil
facility: Sanofi-Aventis Investigational Site Number 076001
city: Porto Alegre
country: Brazil
facility: Sanofi-Aventis Investigational Site Number 076003
city: Rio De Janeiro
country: Brazil
facility: Sanofi-Aventis Investigational Site Number 076002
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Investigational Site Number 076007
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Investigational Site Number 076005
city: Edmonton
country: Canada
facility: Sanofi-Aventis Investigational Site Number 124007
city: London
country: Canada
facility: Sanofi-Aventis Investigational Site Number 124001
city: Montreal
country: Canada
facility: Sanofi-Aventis Investigational Site Number 124006
city: Quebec
country: Canada
facility: Sanofi-Aventis Investigational Site Number 124003
city: Weston
country: Canada
facility: Sanofi-Aventis Investigational Site Number 124002
city: Santiago
country: Chile
facility: Sanofi-Aventis Investigational Site Number 152001
city: Avignon
country: France
facility: Sanofi-Aventis Investigational Site Number 250006
city: Bordeaux Cedex
country: France
facility: Sanofi-Aventis Investigational Site Number 250003
city: Hyeres
country: France
facility: Sanofi-Aventis Investigational Site Number 250005
city: Le Mans
country: France
facility: Sanofi-Aventis Investigational Site Number 250011
city: Lyon
country: France
facility: Sanofi-Aventis Investigational Site Number 250004
city: Perpignan
country: France
facility: Sanofi-Aventis Investigational Site Number 250012
city: Poitiers Cedex
country: France
facility: Sanofi-Aventis Investigational Site Number 250007
city: Saint Herblain
country: France
facility: Sanofi-Aventis Investigational Site Number 250008
city: Strasbourg
country: France
facility: Sanofi-Aventis Investigational Site Number 250009
city: Suresnes
country: France
facility: Sanofi-Aventis Investigational Site Number 250001
city: Bangalore
country: India
facility: Sanofi-Aventis Investigational Site Number 356003
city: Kolkata
country: India
facility: Sanofi-Aventis Investigational Site Number 356007
city: New Delhi
country: India
facility: Sanofi-Aventis Investigational Site Number 356004
city: New Delhi
country: India
facility: Sanofi-Aventis Investigational Site Number 356001
city: Vellore
country: India
facility: Sanofi-Aventis Investigational Site Number 356002
city: Vishakhapatnam
country: India
facility: Sanofi-Aventis Investigational Site Number 356005
city: Haifa
country: Israel
facility: Sanofi-Aventis Investigational Site Number 376005
city: Kfar Saba
country: Israel
facility: Sanofi-Aventis Investigational Site Number 376004
city: Petah-Tikva
country: Israel
facility: Sanofi-Aventis Investigational Site Number 376003
city: Tel Aviv
country: Israel
facility: Sanofi-Aventis Investigational Site Number 376002
city: Tel Hashomer
country: Israel
facility: Sanofi-Aventis Investigational Site Number 376007
city: Tzrifin
country: Israel
facility: Sanofi-Aventis Investigational Site Number 376001
city: Bari
country: Italy
facility: Sanofi-Aventis Investigational Site Number 380004
city: Lecce
country: Italy
facility: Sanofi-Aventis Investigational Site Number 380003
city: Meldola
country: Italy
facility: Sanofi-Aventis Investigational Site Number 380005
city: Pavia
country: Italy
facility: Sanofi-Aventis Investigational Site Number 380006
city: Perugia
country: Italy
facility: Sanofi-Aventis Investigational Site Number 380002
city: Roma
country: Italy
facility: Sanofi-Aventis Investigational Site Number 380001
city: Viterbo
country: Italy
facility: Sanofi-Aventis Investigational Site Number 380008
city: Aguascalientes
country: Mexico
facility: Sanofi-Aventis Investigational Site Number 484003
city: Chihuahua
country: Mexico
facility: Sanofi-Aventis Investigational Site Number 484007
city: Chihuahua
country: Mexico
facility: Sanofi-Aventis Investigational Site Number 484005
city: Monterrey
country: Mexico
facility: Sanofi-Aventis Investigational Site Number 484004
city: Amsterdam
country: Netherlands
facility: Sanofi-Aventis Investigational Site Number 528005
city: Arnhem
country: Netherlands
facility: Sanofi-Aventis Investigational Site Number 528002
city: Hoofddorp
country: Netherlands
facility: Sanofi-Aventis Investigational Site Number 528006
city: Maastricht
country: Netherlands
facility: Sanofi-Aventis Investigational Site Number 528003
city: Nijmegen
country: Netherlands
facility: Sanofi-Aventis Investigational Site Number 528004
city: Sittard-Geleen
country: Netherlands
facility: Sanofi-Aventis Investigational Site Number 528001
city: Zwolle
country: Netherlands
facility: Sanofi-Aventis Investigational Site Number 528007
city: Poznan
country: Poland
facility: Sanofi-Aventis Investigational Site Number 616002
city: Rybnik
country: Poland
facility: Sanofi-Aventis Investigational Site Number 616004
city: Warszawa
country: Poland
facility: Sanofi-Aventis Investigational Site Number 616001
city: Wroclaw
country: Poland
facility: Sanofi-Aventis Investigational Site Number 616005
city: Chelyabinsk
country: Russian Federation
facility: Sanofi-Aventis Investigational Site Number 643009
city: Kursk
country: Russian Federation
facility: Sanofi-Aventis Investigational Site Number 643010
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis Investigational Site Number 643006
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis Investigational Site Number 643008
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis Investigational Site Number 643004
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis Investigational Site Number 643005
city: Obninsk
country: Russian Federation
facility: Sanofi-Aventis Investigational Site Number 643001
city: Saint-Petersburg
country: Russian Federation
facility: Sanofi-Aventis Investigational Site Number 643003
city: Saint-Petersburg
country: Russian Federation
facility: Sanofi-Aventis Investigational Site Number 643007
city: St-Petersburg
country: Russian Federation
facility: Sanofi-Aventis Investigational Site Number 643002
city: St-Petersburg
country: Russian Federation
facility: Sanofi-Aventis Investigational Site Number 643011
city: Bloemfontein
country: South Africa
facility: Sanofi-Aventis Investigational Site Number 710008
city: Cape Town
country: South Africa
facility: Sanofi-Aventis Investigational Site Number 710003
city: Cape Town
country: South Africa
facility: Sanofi-Aventis Investigational Site Number 710001
city: Durban
country: South Africa
facility: Sanofi-Aventis Investigational Site Number 710007
city: Durban
country: South Africa
facility: Sanofi-Aventis Investigational Site Number 710009
city: Port Elizabeth
country: South Africa
facility: Sanofi-Aventis Investigational Site Number 710006
city: Pretoria
country: South Africa
facility: Sanofi-Aventis Investigational Site Number 710005
city: Badalona
country: Spain
facility: Sanofi-Aventis Investigational Site Number 724006
city: Barcelona
country: Spain
facility: Sanofi-Aventis Investigational Site Number 724001
city: Barcelona
country: Spain
facility: Sanofi-Aventis Investigational Site Number 724004
city: Barcelona
country: Spain
facility: Sanofi-Aventis Investigational Site Number 724008
city: Barcelona
country: Spain
facility: Sanofi-Aventis Investigational Site Number 724002
city: Madrid
country: Spain
facility: Sanofi-Aventis Investigational Site Number 724003
city: Oviedo
country: Spain
facility: Sanofi-Aventis Investigational Site Number 724010
city: Palma De Mallorca
country: Spain
facility: Sanofi-Aventis Investigational Site Number 724013
city: Palma De Mallorca
country: Spain
facility: Sanofi-Aventis Investigational Site Number 724007
city: Pamplona
country: Spain
facility: Sanofi-Aventis Investigational Site Number 724009
city: Santiago De Compostela
country: Spain
facility: Sanofi-Aventis Investigational Site Number 724011
city: Zaragoza
country: Spain
facility: Sanofi-Aventis Investigational Site Number 724012
city: Umeå
country: Sweden
facility: Sanofi-Aventis Investigational Site Number 752001
city: Uppsala
country: Sweden
facility: Sanofi-Aventis Investigational Site Number 752002
city: Ankara
country: Turkey
facility: Sanofi-Aventis Investigational Site Number 792002
city: Ankara
country: Turkey
facility: Sanofi-Aventis Investigational Site Number 792003
city: Ankara
country: Turkey
facility: Sanofi-Aventis Investigational Site Number 792004
city: Istanbul
country: Turkey
facility: Sanofi-Aventis Investigational Site Number 792006
city: Istanbul
country: Turkey
facility: Sanofi-Aventis Investigational Site Number 792001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: