Larotaxel + Cisplatin Versus Gemcitabine + Cisplatin in First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer (CILAB)

April 6, 2016 updated by: Sanofi

Randomized Study of LAROTAXEL + Cisplatin (LC) vs. Gemcitabine + Cisplatin (GC) in the First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

337

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1120AAT
        • Sanofi-Aventis Investigational Site Number 032002
      • Ciudad De Buenos Aires, Argentina, C1426BOR
        • Sanofi-Aventis Investigational Site Number 032003
      • Mendoza, Argentina, 5500
        • Sanofi-Aventis Investigational Site Number 032004
      • Rosario, Argentina, 2000
        • Sanofi-Aventis Investigational Site Number 032005
      • Santa Fe, Argentina, 3000
        • Sanofi-Aventis Investigational Site Number 032001
  • Australia
      • Adelaide, Australia, 5000
        • Sanofi-Aventis Investigational Site Number 036002
      • Bedford Park, Australia, 5042
        • Sanofi-Aventis Investigational Site Number 036003
      • St Leonards, Australia, 2065
        • Sanofi-Aventis Investigational Site Number 036004
  • Belgium
      • Aalst, Belgium, 9300
        • Sanofi-Aventis Investigational Site Number 056005
      • Bruxelles, Belgium, 1000
        • Sanofi-Aventis Investigational Site Number 056001
      • Bruxelles, Belgium, 1200
        • Sanofi-Aventis Investigational Site Number 056002
      • Ottignies, Belgium, 1340
        • Sanofi-Aventis Investigational Site Number 056004
      • Wilrijk, Belgium, 2610
        • Sanofi-Aventis Investigational Site Number 056003
      • Yvoir, Belgium, 5530
        • Sanofi-Aventis Investigational Site Number 056006
  • Brazil
      • Barretos, Brazil, 14784-400
        • Sanofi-Aventis Investigational Site Number 076006
      • Florianopolis, Brazil, 88034-000
        • Sanofi-Aventis Investigational Site Number 076004
      • Porto Alegre, Brazil, 90110-270
        • Sanofi-Aventis Investigational Site Number 076001
      • Porto Alegre, Brazil, 90610-000
        • Sanofi-Aventis Investigational Site Number 076003
      • Rio De Janeiro, Brazil, 20231-050
        • Sanofi-Aventis Investigational Site Number 076002
      • Sao Paulo, Brazil, 01246-000
        • Sanofi-Aventis Investigational Site Number 076007
      • Sao Paulo, Brazil, 04122 000
        • Sanofi-Aventis Investigational Site Number 076005
  • Canada
      • Edmonton, Canada, T6G1Z2
        • Sanofi-Aventis Investigational Site Number 124007
      • London, Canada, N6A 4L6
        • Sanofi-Aventis Investigational Site Number 124001
      • Montreal, Canada, H2L 4M1
        • Sanofi-Aventis Investigational Site Number 124006
      • Quebec, Canada, G1R 2J6
        • Sanofi-Aventis Investigational Site Number 124003
      • Weston, Canada, M9N 1N8
        • Sanofi-Aventis Investigational Site Number 124002
  • Chile
      • Santiago, Chile, 8380455
        • Sanofi-Aventis Investigational Site Number 152001
  • France
      • Avignon, France, 84082
        • Sanofi-Aventis Investigational Site Number 250006
      • Bordeaux Cedex, France, 33076
        • Sanofi-Aventis Investigational Site Number 250003
      • Hyeres, France, 83400
        • Sanofi-Aventis Investigational Site Number 250005
      • Le Mans, France, 72015
        • Sanofi-Aventis Investigational Site Number 250011
      • Lyon, France, 69008
        • Sanofi-Aventis Investigational Site Number 250004
      • Perpignan, France, 66012
        • Sanofi-Aventis Investigational Site Number 250012
      • Poitiers Cedex, France, 86021
        • Sanofi-Aventis Investigational Site Number 250007
      • Saint Herblain, France, 44805
        • Sanofi-Aventis Investigational Site Number 250008
      • Strasbourg, France, 67091
        • Sanofi-Aventis Investigational Site Number 250009
      • Suresnes, France, 92151
        • Sanofi-Aventis Investigational Site Number 250001
  • India
      • Bangalore, India, 560029
        • Sanofi-Aventis Investigational Site Number 356003
      • Kolkata, India, 700026
        • Sanofi-Aventis Investigational Site Number 356007
      • New Delhi, India, 110 029
        • Sanofi-Aventis Investigational Site Number 356004
      • New Delhi, India, 110001
        • Sanofi-Aventis Investigational Site Number 356001
      • Vellore, India, 632004
        • Sanofi-Aventis Investigational Site Number 356002
      • Vishakhapatnam, India, 530002
        • Sanofi-Aventis Investigational Site Number 356005
  • Israel
      • Haifa, Israel, 31096
        • Sanofi-Aventis Investigational Site Number 376005
      • Kfar Saba, Israel, 44281
        • Sanofi-Aventis Investigational Site Number 376004
      • Petah-Tikva, Israel, 49100
        • Sanofi-Aventis Investigational Site Number 376003
      • Tel Aviv, Israel, 64239
        • Sanofi-Aventis Investigational Site Number 376002
      • Tel Hashomer, Israel, 52621
        • Sanofi-Aventis Investigational Site Number 376007
      • Tzrifin, Israel, 70300
        • Sanofi-Aventis Investigational Site Number 376001
  • Italy
      • Bari, Italy, 70124
        • Sanofi-Aventis Investigational Site Number 380004
      • Lecce, Italy, 73100
        • Sanofi-Aventis Investigational Site Number 380003
      • Meldola, Italy, 47014
        • Sanofi-Aventis Investigational Site Number 380005
      • Pavia, Italy, 27100
        • Sanofi-Aventis Investigational Site Number 380006
      • Perugia, Italy, 06128
        • Sanofi-Aventis Investigational Site Number 380002
      • Roma, Italy, 00152
        • Sanofi-Aventis Investigational Site Number 380001
      • Viterbo, Italy, 01100
        • Sanofi-Aventis Investigational Site Number 380008
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Sanofi-Aventis Investigational Site Number 484003
      • Chihuahua, Mexico, 31000
        • Sanofi-Aventis Investigational Site Number 484007
      • Chihuahua, Mexico, 31205
        • Sanofi-Aventis Investigational Site Number 484005
      • Monterrey, Mexico, 64988
        • Sanofi-Aventis Investigational Site Number 484004
  • Netherlands
      • Amsterdam, Netherlands, 1091 HA
        • Sanofi-Aventis Investigational Site Number 528005
      • Arnhem, Netherlands, 6815 AD
        • Sanofi-Aventis Investigational Site Number 528002
      • Hoofddorp, Netherlands, 2134 TM
        • Sanofi-Aventis Investigational Site Number 528006
      • Maastricht, Netherlands, 6229 HX
        • Sanofi-Aventis Investigational Site Number 528003
      • Nijmegen, Netherlands, 6525 GA
        • Sanofi-Aventis Investigational Site Number 528004
      • Sittard-Geleen, Netherlands, 6162 BG
        • Sanofi-Aventis Investigational Site Number 528001
      • Zwolle, Netherlands, 8025 AB
        • Sanofi-Aventis Investigational Site Number 528007
  • Poland
      • Poznan, Poland, 61-485
        • Sanofi-Aventis Investigational Site Number 616002
      • Rybnik, Poland, 44-200
        • Sanofi-Aventis Investigational Site Number 616004
      • Warszawa, Poland, 02-781
        • Sanofi-Aventis Investigational Site Number 616001
      • Wroclaw, Poland, 51-124
        • Sanofi-Aventis Investigational Site Number 616005
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454087
        • Sanofi-Aventis Investigational Site Number 643009
      • Kursk, Russian Federation, 305035
        • Sanofi-Aventis Investigational Site Number 643010
      • Moscow, Russian Federation, 105425
        • Sanofi-Aventis Investigational Site Number 643006
      • Moscow, Russian Federation, 115478
        • Sanofi-Aventis Investigational Site Number 643008
      • Moscow, Russian Federation, 117837
        • Sanofi-Aventis Investigational Site Number 643004
      • Moscow, Russian Federation, 125284
        • Sanofi-Aventis Investigational Site Number 643005
      • Obninsk, Russian Federation, 249036
        • Sanofi-Aventis Investigational Site Number 643001
      • Saint-Petersburg, Russian Federation, 194354
        • Sanofi-Aventis Investigational Site Number 643003
      • Saint-Petersburg, Russian Federation, 197758
        • Sanofi-Aventis Investigational Site Number 643007
      • St-Petersburg, Russian Federation, 191104
        • Sanofi-Aventis Investigational Site Number 643002
      • St-Petersburg, Russian Federation, 197758
        • Sanofi-Aventis Investigational Site Number 643011
  • South Africa
      • Bloemfontein, South Africa, 9301
        • Sanofi-Aventis Investigational Site Number 710008
      • Cape Town, South Africa, 7506
        • Sanofi-Aventis Investigational Site Number 710003
      • Cape Town, South Africa, 7956
        • Sanofi-Aventis Investigational Site Number 710001
      • Durban, South Africa, 4062
        • Sanofi-Aventis Investigational Site Number 710007
      • Durban, South Africa, 4091
        • Sanofi-Aventis Investigational Site Number 710009
      • Port Elizabeth, South Africa, 6001
        • Sanofi-Aventis Investigational Site Number 710006
      • Pretoria, South Africa, 0181
        • Sanofi-Aventis Investigational Site Number 710005
  • Spain
      • Badalona, Spain, 08916
        • Sanofi-Aventis Investigational Site Number 724006
      • Barcelona, Spain, 08036
        • Sanofi-Aventis Investigational Site Number 724002
      • Barcelona, Spain, 08003
        • Sanofi-Aventis Investigational Site Number 724001
      • Barcelona, Spain, 08025
        • Sanofi-Aventis Investigational Site Number 724004
      • Barcelona, Spain, 08035
        • Sanofi-Aventis Investigational Site Number 724008
      • Madrid, Spain, 28041
        • Sanofi-Aventis Investigational Site Number 724003
      • Oviedo, Spain, 33006
        • Sanofi-Aventis Investigational Site Number 724010
      • Palma De Mallorca, Spain, 07014
        • Sanofi-Aventis Investigational Site Number 724013
      • Palma De Mallorca, Spain, 07198
        • Sanofi-Aventis Investigational Site Number 724007
      • Pamplona, Spain, 31008
        • Sanofi-Aventis Investigational Site Number 724009
      • Santiago De Compostela, Spain, 15706
        • Sanofi-Aventis Investigational Site Number 724011
      • Zaragoza, Spain, 50009
        • Sanofi-Aventis Investigational Site Number 724012
  • Sweden
      • Umeå, Sweden, 901 85
        • Sanofi-Aventis Investigational Site Number 752001
      • Uppsala, Sweden, 751 85
        • Sanofi-Aventis Investigational Site Number 752002
  • Turkey
      • Ankara, Turkey, 06100
        • Sanofi-Aventis Investigational Site Number 792002
      • Ankara, Turkey, 065090
        • Sanofi-Aventis Investigational Site Number 792003
      • Ankara, Turkey, 61080
        • Sanofi-Aventis Investigational Site Number 792004
      • Istanbul, Turkey, 22030
        • Sanofi-Aventis Investigational Site Number 792006
      • Istanbul, Turkey, 34093
        • Sanofi-Aventis Investigational Site Number 792001
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Sanofi-Aventis Investigational Site Number 840068
    • California
      • Berkeley, California, United States, 94704
        • Sanofi-Aventis Investigational Site Number 840035
      • Burbank, California, United States, 91505
        • Sanofi-Aventis Investigational Site Number 840012
      • La Jolla, California, United States, 92037
        • Sanofi-Aventis Investigational Site Number 840029
      • Los Angeles, California, United States, 90033
        • Sanofi-Aventis Investigational Site Number 840046
      • Sacramento, California, United States, 95817
        • Sanofi-Aventis Investigational Site Number 840003
      • San Bernardino, California, United States, 92404
        • Sanofi-Aventis Investigational Site Number 840005
      • San Diego, California, United States, 92103
        • Sanofi-Aventis Investigational Site Number 840033
    • Colorado
      • Denver, Colorado, United States, 80262
        • Sanofi-Aventis Investigational Site Number 840031
    • Connecticut
      • Stamford, Connecticut, United States, 06902
        • Sanofi-Aventis Investigational Site Number 840032
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Sanofi-Aventis Investigational Site Number 840034
      • Washington, District of Columbia, United States, 20010
        • Sanofi-Aventis Investigational Site Number 840021
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Sanofi-Aventis Investigational Site Number 840001
      • Boynton Beach, Florida, United States, 33435
        • Sanofi-Aventis Investigational Site Number 840048
      • Jacksonville, Florida, United States, 32224
        • Sanofi-Aventis Investigational Site Number 840049
      • Lakeland, Florida, United States, 33805
        • Sanofi-Aventis Investigational Site Number 840061
    • Georgia
      • Athens, Georgia, United States, 30607
        • Sanofi-Aventis Investigational Site Number 840060
    • Idaho
      • Boise, Idaho, United States, 83712
        • Sanofi-Aventis Investigational Site Number 840030
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Sanofi-Aventis Investigational Site Number 840024
      • Peoria, Illinois, United States, 61615
        • Sanofi-Aventis Investigational Site Number 840062
    • Indiana
      • Goshen, Indiana, United States, 46526
        • Sanofi-Aventis Investigational Site Number 840039
    • Kansas
      • Kansas City, Kansas, United States, 66160-7321
        • Sanofi-Aventis Investigational Site Number 840054
    • Kentucky
      • Paducah, Kentucky, United States, 42002
        • Sanofi-Aventis Investigational Site Number 840057
    • Louisiana
      • Metarie, Louisiana, United States, 70006-290
        • Sanofi-Aventis Investigational Site Number 840004
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Sanofi-Aventis Investigational Site Number 840045
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Sanofi-Aventis Investigational Site Number 840006
      • Lansing, Michigan, United States, 48510
        • Sanofi-Aventis Investigational Site Number 840026
      • St. Joseph, Michigan, United States, 49805
        • Sanofi-Aventis Investigational Site Number 840047
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Sanofi-Aventis Investigational Site Number 840009
    • New York
      • Lake Success, New York, United States, 11042
        • Sanofi-Aventis Investigational Site Number 840044
      • New York, New York, United States, 10021
        • Sanofi-Aventis Investigational Site Number 840013
      • New York, New York, United States, 10032
        • Sanofi-Aventis Investigational Site Number 840050
      • Rochester, New York, United States, 14642
        • Sanofi-Aventis Investigational Site Number 840056
      • Syracuse, New York, United States, 13210
        • Sanofi-Aventis Investigational Site Number 840015
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Sanofi-Aventis Investigational Site Number 840041
      • Charlotte, North Carolina, United States, 28204
        • Sanofi-Aventis Investigational Site Number 840007
    • Ohio
      • Sylvania, Ohio, United States, 43560
        • Sanofi-Aventis Investigational Site Number 840019
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Sanofi-Aventis Investigational Site Number 840020
      • Dunmore, Pennsylvania, United States, 18512
        • Sanofi-Aventis Investigational Site Number 840065
    • Rhode Island
      • Woonsocket, Rhode Island, United States, 02895
        • Sanofi-Aventis Investigational Site Number 840058
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Sanofi-Aventis Investigational Site Number 840052
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Sanofi-Aventis Investigational Site Number 840002
    • Texas
      • Houston, Texas, United States, 77014
        • Sanofi-Aventis Investigational Site Number 840008
      • Houston, Texas, United States, 77030
        • Sanofi-Aventis Investigational Site Number 840018
      • Lubbock, Texas, United States, 79415
        • Sanofi-Aventis Investigational Site Number 840017
      • San Antonio, Texas, United States, 78229
        • Sanofi-Aventis Investigational Site Number 840016
      • Temple, Texas, United States, 76508
        • Sanofi-Aventis Investigational Site Number 840064
      • Woodlands, Texas, United States, 77380
        • Sanofi-Aventis Investigational Site Number 840010
    • Washington
      • Seattle, Washington, United States, 98111
        • Sanofi-Aventis Investigational Site Number 840036
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Sanofi-Aventis Investigational Site Number 840011
      • Marshfield, Wisconsin, United States, 54449
        • Sanofi-Aventis Investigational Site Number 840025
      • Milwaukee, Wisconsin, United States, 53226
        • Sanofi-Aventis Investigational Site Number 840038

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: larotaxel (XRP9881)
administered on day 1 as a 1-hour infusion
Drug: cisplatin
1 hour infusion administered on day 1, 30 minutes after the other treatment
Active Comparator: 2
Drug: cisplatin
1 hour infusion administered on day 1, 30 minutes after the other treatment
Drug: gemcitabine
administered on day 1, 8 and 15 as a 30-minute infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival defined as the time interval from the date of randomization to the date of death due to any cause
Time Frame: study period
study period

Secondary Outcome Measures

Outcome Measure
Time Frame
Radiological tumor assessments (CT/MRI)
Time Frame: at screening, every 8 weeks during treatment, at end of treatment, and in follow-up until documented disease progression
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
Time Frame: at screening and every cycle
at screening and every cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

February 19, 2008

First Submitted That Met QC Criteria

February 19, 2008

First Posted (Estimate)

February 28, 2008

Study Record Updates

Last Update Posted (Estimate)

May 5, 2016

Last Update Submitted That Met QC Criteria

April 6, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC6668
  • EUDRACT: 2007-001943-23

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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