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


Tracking Information

Start Date  ICMJEFebruary 2008
Estimated Primary Completion DateOctober 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 HistoryComplete list of historical versions of study NCT00625664 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: August 21, 2008)
  • Radiological tumor assessments (CT/MRI) [ Time Frame: at screening, every 8 weeks during treatment, at end of treatment, and in follow-up until documented disease progression ] [ Designated as safety issue: No ]
  • Adverse Events, laboratory assessments, vital signs, Physical Examinations, and ECOG Performance Status [ Time Frame: at screening and every cycle ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: February 19, 2008)
  • Radiological tumor assessments (CT/MRI) [ Time Frame: at screening, every 8 weeks during treatment, at end of treatment, and in follow-up until documented disease progression ]
  • Adverse Events, laboratory assessments, vital signs, Physical Examinations, and ECOG Performance Status [ Time Frame: at screening and every cycle ]

Descriptive Information

Brief Title  ICMJELarotaxel + Cisplatin Versus Gemcitabine + Cisplatin in First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer
Official Title  ICMJERandomized 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 PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Condition  ICMJEUrinary Bladder Neoplasms
Intervention  ICMJE
  • 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
Study Arms / Comparison Groups
  • 1: Experimental
    Interventions:
    • Drug: larotaxel (XRP9881)
    • Drug: cisplatin
  • 2: Active Comparator
    Interventions:
    • Drug: gemcitabine
    • Drug: cisplatin

Recruitment Information

Estimated Enrollment  ICMJE900
Estimated Completion DateOctober 2011
Estimated Primary Completion DateOctober 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 Criteria:

  • (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.

GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: For site information, send an email with site number toGV-Contact-us@sanofi-aventis.com
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Belgium,   Brazil,   Canada,   France,   India,   Israel,   Italy,   Mexico,   Netherlands,   Poland,   Russian Federation,   South Africa,   Spain,   Sweden,   Turkey

Administrative Information

NCT ID  ICMJENCT00625664
Responsible PartyICD Study Director, sanofi-aventis
Study ID Numbers  ICMJEEFC6668, EUDRACT: 2007-001943-23
Study Sponsor  ICMJESanofi-Aventis
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:ICD CSDSanofi-Aventis
Information Provided BySanofi-Aventis