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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00625664




Registration number
NCT00625664
Ethics application status
Date submitted
19/02/2008
Date registered
28/02/2008
Date last updated
5/05/2016

Titles & IDs
Public title
Larotaxel + Cisplatin Versus Gemcitabine + Cisplatin in First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer
Scientific 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
Secondary ID [1] 0 0
EUDRACT: 2007-001943-23
Secondary ID [2] 0 0
EFC6668
Universal Trial Number (UTN)
Trial acronym
CILAB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary Bladder Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bladder - transitional cell cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - larotaxel (XRP9881)
Treatment: Drugs - gemcitabine
Treatment: Drugs - cisplatin

Experimental: 1 -

Active comparator: 2 -


Treatment: Drugs: larotaxel (XRP9881)
administered on day 1 as a 1-hour infusion

Treatment: Drugs: gemcitabine
administered on day 1, 8 and 15 as a 30-minute infusion

Treatment: Drugs: cisplatin
1 hour infusion administered on day 1, 30 minutes after the other treatment
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival defined as the time interval from the date of randomization to the date of death due to any cause
Timepoint [1] 0 0
study period
Secondary outcome [1] 0 0
Radiological tumor assessments (CT/MRI)
Timepoint [1] 0 0
at screening, every 8 weeks during treatment, at end of treatment, and in follow-up until documented disease progression
Secondary outcome [2] 0 0
Adverse Events, laboratory assessments, vital signs, Physical Examinations, and ECOG Performance Status
Timepoint [2] 0 0
at screening and every cycle

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2011
Sample size
Target
Accrual to date
Final
337
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis Investigational Site Number 036002 - Adelaide
Recruitment hospital [2] 0 0
Sanofi-Aventis Investigational Site Number 036003 - Bedford Park
Recruitment hospital [3] 0 0
Sanofi-Aventis Investigational Site Number 036004 - St Leonards
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alaska
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United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
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United States of America
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Connecticut
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Idaho
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Illinois
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Indiana
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Kansas
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Kentucky
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Louisiana
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Maryland
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Michigan
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New Jersey
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New York
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North Carolina
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Ohio
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Pennsylvania
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Rhode Island
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South Carolina
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Tennessee
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Texas
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Washington
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Ciudad De Buenos Aires
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Argentina
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Mendoza
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Argentina
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Rosario
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Argentina
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Santa Fe
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Belgium
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Aalst
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Belgium
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Bruxelles
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Belgium
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Ottignies
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Belgium
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Wilrijk
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Yvoir
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Barretos
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Florianopolis
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London
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Montreal
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Quebec
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Weston
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Chile
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Santiago
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Avignon
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Hyeres
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Le Mans
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Lyon
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Perpignan
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Saint Herblain
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France
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Strasbourg
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Suresnes
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India
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Bangalore
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Kolkata
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Vellore
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Haifa
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Kfar Saba
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Petah-Tikva
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Tel Hashomer
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Tzrifin
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Bari
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Lecce
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Meldola
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Pavia
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Roma
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Arnhem
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Hoofddorp
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Maastricht
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Zwolle
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Rybnik
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Wroclaw
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Russian Federation
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Chelyabinsk
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Russian Federation
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Kursk
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Russian Federation
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Moscow
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Russian Federation
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Obninsk
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Bloemfontein
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South Africa
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Cape Town
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South Africa
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Durban
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Port Elizabeth
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South Africa
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Pretoria
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Spain
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Badalona
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Barcelona
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Madrid
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Oviedo
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Spain
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Palma De Mallorca
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Spain
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Pamplona
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Spain
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Santiago De Compostela
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Zaragoza
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Sweden
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Umeå
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Sweden
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Uppsala
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Turkey
State/province [111] 0 0
Ankara
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Turkey
State/province [112] 0 0
Istanbul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00625664