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

Completed · Phase 3

Conditions studied: Urinary Bladder Neoplasms

In brief

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.

Key facts

Study ID

NCT00625664

Run by

Sanofi

People needed

337

Starts

2008-02-01

Expected to finish

2011-02-01

Last updated by the study team

2016-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• (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.

Where it is running

• Sanofi-Aventis Investigational Site Number 643007 — Saint Petersburg, Russia
• Sanofi-Aventis Investigational Site Number 643011 — Saint Petersburg, Russia
• Sanofi-Aventis Investigational Site Number 710008 — Bloemfontein, South Africa
• Sanofi-Aventis Investigational Site Number 710003 — Cape Town, South Africa
• Sanofi-Aventis Investigational Site Number 710001 — Cape Town, South Africa
• Sanofi-Aventis Investigational Site Number 710007 — Durban, South Africa
• Sanofi-Aventis Investigational Site Number 710009 — Durban, South Africa
• Sanofi-Aventis Investigational Site Number 710006 — Port Elizabeth, South Africa
• Sanofi-Aventis Investigational Site Number 710005 — Pretoria, South Africa
• Sanofi-Aventis Investigational Site Number 724006 — Badalona, Spain
• Sanofi-Aventis Investigational Site Number 724001 — Barcelona, Spain
• Sanofi-Aventis Investigational Site Number 724004 — Barcelona, Spain
• Sanofi-Aventis Investigational Site Number 724008 — Barcelona, Spain
• Sanofi-Aventis Investigational Site Number 724002 — Barcelona, Spain
• Sanofi-Aventis Investigational Site Number 724003 — Madrid, Spain
• Sanofi-Aventis Investigational Site Number 724010 — Oviedo, Spain
• Sanofi-Aventis Investigational Site Number 724013 — Palma de Mallorca, Spain
• Sanofi-Aventis Investigational Site Number 724007 — Palma de Mallorca, Spain
• Sanofi-Aventis Investigational Site Number 724009 — Pamplona, Spain
• Sanofi-Aventis Investigational Site Number 724011 — Santiago de Compostela, Spain
• Sanofi-Aventis Investigational Site Number 724012 — Zaragoza, Spain
• Sanofi-Aventis Investigational Site Number 752001 — Umeå, Sweden
• Sanofi-Aventis Investigational Site Number 752002 — Uppsala, Sweden
• Sanofi-Aventis Investigational Site Number 792002 — Ankara, Turkey (Türkiye)
• Sanofi-Aventis Investigational Site Number 643003 — Saint Petersburg, Russia

Full record on ClinicalTrials.gov

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