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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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United States of America
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Alaska
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California
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Colorado
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Mendoza
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Rosario
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Moscow
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Bloemfontein
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Durban
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Pretoria
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Barcelona
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Sweden
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Umeå
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Uppsala
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Ankara
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Turkey
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Istanbul

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

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00625664
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