Tracking Information
Start Date ICMJE | February 2008 |
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Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: August 21, 2008) | 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 ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE (submitted: February 19, 2008) | Overall survival defined as the time interval from the date of randomization to the date of death due to any cause |
Change History | Complete list of historical versions of study NCT00625664 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: August 21, 2008) |
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Original Secondary Outcome Measures ICMJE (submitted: February 19, 2008) |
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Descriptive Information
Brief Title ICMJE | Larotaxel + Cisplatin Versus Gemcitabine + Cisplatin in First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer |
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Official Title ICMJE | Randomized Study of LAROTAXEL + Cisplatin (LC) vs. Gemcitabine + Cisplatin (GC) in the First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer |
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 | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Condition ICMJE | Urinary Bladder Neoplasms |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 900 | ||||
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Estimated Completion Date | October 2011 | ||||
Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. | ||||
Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Argentina, Australia, Belgium, Brazil, Canada, France, India, Israel, Italy, Mexico, Netherlands, Poland, Russian Federation, South Africa, Spain, Sweden, Turkey |
Administrative Information
NCT ID ICMJE | NCT00625664 | ||||
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Responsible Party | ICD Study Director, sanofi-aventis | ||||
Study ID Numbers ICMJE | EFC6668, EUDRACT: 2007-001943-23 | ||||
Study Sponsor ICMJE | Sanofi-Aventis | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Sanofi-Aventis |