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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Urinary Bladder Neoplasms

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival defined as the time interval from the date of randomization to the date of death due to any cause

Outcome Time Frame:

study period

Safety Issue:

No

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

EFC6668

NCT ID:

NCT00625664

Start Date:

February 2008

Completion Date:

February 2011

Related Keywords:

  • Urinary Bladder Neoplasms
  • Cancer
  • Neoplasms
  • Bladder
  • Urothelial Tract
  • Urinary Bladder Neoplasms
  • Neoplasms

Name

Location

Sanofi-Aventis Investigational Site Number 840020Philadelphia, Pennsylvania  19104
Sanofi-Aventis Investigational Site Number 840068Anchorage, Alaska  99508
Sanofi-Aventis Investigational Site Number 840035Berkeley, California  94704
Sanofi-Aventis Investigational Site Number 840012Burbank, California  91505
Sanofi-Aventis Investigational Site Number 840029La Jolla, California  92037
Sanofi-Aventis Investigational Site Number 840046Los Angeles, California  90033
Sanofi-Aventis Investigational Site Number 840003Sacramento, California  95817
Sanofi-Aventis Investigational Site Number 840005San Bernardino, California  92404
Sanofi-Aventis Investigational Site Number 840033San Diego, California  92103
Sanofi-Aventis Investigational Site Number 840031Denver, Colorado  80262
Sanofi-Aventis Investigational Site Number 840032Stamford, Connecticut  06902
Sanofi-Aventis Investigational Site Number 840021Washington, District of Columbia  20010
Sanofi-Aventis Investigational Site Number 840034Washington, District of Columbia  20007
Sanofi-Aventis Investigational Site Number 840001Boca Raton, Florida  33486
Sanofi-Aventis Investigational Site Number 840048Boynton Beach, Florida  33435
Sanofi-Aventis Investigational Site Number 840049Jacksonville, Florida  32224
Sanofi-Aventis Investigational Site Number 840061Lakeland, Florida  33805
Sanofi-Aventis Investigational Site Number 840060Athens, Georgia  30607
Sanofi-Aventis Investigational Site Number 840030Boise, Idaho  83712
Sanofi-Aventis Investigational Site Number 840024Maywood, Illinois  60153
Sanofi-Aventis Investigational Site Number 840062Peoria, Illinois  61615
Sanofi-Aventis Investigational Site Number 840039Goshen, Indiana  46526
Sanofi-Aventis Investigational Site Number 840054Kansas City, Kansas  66160-7321
Sanofi-Aventis Investigational Site Number 840057Paducah, Kentucky  42002
Sanofi-Aventis Investigational Site Number 840004Metarie, Louisiana  70006-290
Sanofi-Aventis Investigational Site Number 840045Baltimore, Maryland  21201
Sanofi-Aventis Investigational Site Number 840006Detroit, Michigan  48201
Sanofi-Aventis Investigational Site Number 840026Lansing, Michigan  48510
Sanofi-Aventis Investigational Site Number 840047St. Joseph, Michigan  49805
Sanofi-Aventis Investigational Site Number 840009Hackensack, New Jersey  07601
Sanofi-Aventis Investigational Site Number 840044Lake Success, New York  11042
Sanofi-Aventis Investigational Site Number 840013New York, New York  10021
Sanofi-Aventis Investigational Site Number 840050New York, New York  10032
Sanofi-Aventis Investigational Site Number 840056Rochester, New York  14642
Sanofi-Aventis Investigational Site Number 840015Syracuse, New York  13210
Sanofi-Aventis Investigational Site Number 840041Chapel Hill, North Carolina  27599
Sanofi-Aventis Investigational Site Number 840007Charlotte, North Carolina  28204
Sanofi-Aventis Investigational Site Number 840019Sylvania, Ohio  43560
Sanofi-Aventis Investigational Site Number 840065Dunmore, Pennsylvania  18512
Sanofi-Aventis Investigational Site Number 840058Woonsocket, Rhode Island  02895
Sanofi-Aventis Investigational Site Number 840052Charleston, South Carolina  29406
Sanofi-Aventis Investigational Site Number 840002Knoxville, Tennessee  37920
Sanofi-Aventis Investigational Site Number 840008Houston, Texas  77014
Sanofi-Aventis Investigational Site Number 840018Houston, Texas  77030
Sanofi-Aventis Investigational Site Number 840017Lubbock, Texas  79415
Sanofi-Aventis Investigational Site Number 840016San Antonio, Texas  78229
Sanofi-Aventis Investigational Site Number 840064Temple, Texas  76508
Sanofi-Aventis Investigational Site Number 840010Woodlands, Texas  77380
Sanofi-Aventis Investigational Site Number 840036Seattle, Washington  98111
Sanofi-Aventis Investigational Site Number 840011Madison, Wisconsin  53792
Sanofi-Aventis Investigational Site Number 840025Marshfield, Wisconsin  54449
Sanofi-Aventis Investigational Site Number 840038Milwaukee, Wisconsin  53226