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Randomized Study of LAROTAXEL + Cisplatin (LC) vs. Gemcitabine + Cisplatin (GC) in the First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer (CILAB)
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.
Details
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 337 |
| Start date | 2008-02 |
| Completion | 2011-02 |
Conditions
- Urinary Bladder Neoplasms
Interventions
- larotaxel (XRP9881)
- gemcitabine
- cisplatin
Primary outcomes
- Overall survival defined as the time interval from the date of randomization to the date of death due to any cause — study period
Countries
United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, France, India, Israel, Italy, Mexico, Netherlands, Poland, Russia, South Africa, Spain, Sweden, Turkey (Türkiye)