NCT00625664

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 337 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Bladder Neoplasms

Interventions

Type	Name	Description
DRUG	larotaxel (XRP9881)	administered on day 1 as a 1-hour infusion
DRUG	gemcitabine	administered on day 1, 8 and 15 as a 30-minute infusion
DRUG	cisplatin	1 hour infusion administered on day 1, 30 minutes after the other treatment

Timeline

• Start date: 2008-02-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2008-02-28
• Last updated: 2016-05-05

Locations

160 sites across 19 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, France, India, Israel, Italy, Mexico, Netherlands, Poland, Russia, South Africa, Spain, Sweden, Turkey (Türkiye)