Status:
COMPLETED
Larotaxel + Cisplatin Versus Gemcitabine + Cisplatin in First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer
Lead Sponsor:
Sanofi
Conditions:
Urinary Bladder Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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/metastati...
Eligibility Criteria
Inclusion
- 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
Exclusion
- (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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
337 Patients enrolled
Trial Details
Trial ID
NCT00625664
Start Date
February 1 2008
End Date
February 1 2011
Last Update
May 5 2016
Active Locations (160)
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1
Sanofi-Aventis Investigational Site Number 840068
Anchorage, Alaska, United States, 99508
2
Sanofi-Aventis Investigational Site Number 840035
Berkeley, California, United States, 94704
3
Sanofi-Aventis Investigational Site Number 840012
Burbank, California, United States, 91505
4
Sanofi-Aventis Investigational Site Number 840029
La Jolla, California, United States, 92037