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
18 Years
N/A
Not Enrolling
Both
Urinary Bladder Neoplasms
Both
Urinary Bladder Neoplasms
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 840020 | Philadelphia, Pennsylvania 19104 |
| Sanofi-Aventis Investigational Site Number 840068 | Anchorage, Alaska 99508 |
| Sanofi-Aventis Investigational Site Number 840035 | Berkeley, California 94704 |
| Sanofi-Aventis Investigational Site Number 840012 | Burbank, California 91505 |
| Sanofi-Aventis Investigational Site Number 840029 | La Jolla, California 92037 |
| Sanofi-Aventis Investigational Site Number 840046 | Los Angeles, California 90033 |
| Sanofi-Aventis Investigational Site Number 840003 | Sacramento, California 95817 |
| Sanofi-Aventis Investigational Site Number 840005 | San Bernardino, California 92404 |
| Sanofi-Aventis Investigational Site Number 840033 | San Diego, California 92103 |
| Sanofi-Aventis Investigational Site Number 840031 | Denver, Colorado 80262 |
| Sanofi-Aventis Investigational Site Number 840032 | Stamford, Connecticut 06902 |
| Sanofi-Aventis Investigational Site Number 840021 | Washington, District of Columbia 20010 |
| Sanofi-Aventis Investigational Site Number 840034 | Washington, District of Columbia 20007 |
| Sanofi-Aventis Investigational Site Number 840001 | Boca Raton, Florida 33486 |
| Sanofi-Aventis Investigational Site Number 840048 | Boynton Beach, Florida 33435 |
| Sanofi-Aventis Investigational Site Number 840049 | Jacksonville, Florida 32224 |
| Sanofi-Aventis Investigational Site Number 840061 | Lakeland, Florida 33805 |
| Sanofi-Aventis Investigational Site Number 840060 | Athens, Georgia 30607 |
| Sanofi-Aventis Investigational Site Number 840030 | Boise, Idaho 83712 |
| Sanofi-Aventis Investigational Site Number 840024 | Maywood, Illinois 60153 |
| Sanofi-Aventis Investigational Site Number 840062 | Peoria, Illinois 61615 |
| Sanofi-Aventis Investigational Site Number 840039 | Goshen, Indiana 46526 |
| Sanofi-Aventis Investigational Site Number 840054 | Kansas City, Kansas 66160-7321 |
| Sanofi-Aventis Investigational Site Number 840057 | Paducah, Kentucky 42002 |
| Sanofi-Aventis Investigational Site Number 840004 | Metarie, Louisiana 70006-290 |
| Sanofi-Aventis Investigational Site Number 840045 | Baltimore, Maryland 21201 |
| Sanofi-Aventis Investigational Site Number 840006 | Detroit, Michigan 48201 |
| Sanofi-Aventis Investigational Site Number 840026 | Lansing, Michigan 48510 |
| Sanofi-Aventis Investigational Site Number 840047 | St. Joseph, Michigan 49805 |
| Sanofi-Aventis Investigational Site Number 840009 | Hackensack, New Jersey 07601 |
| Sanofi-Aventis Investigational Site Number 840044 | Lake Success, New York 11042 |
| Sanofi-Aventis Investigational Site Number 840013 | New York, New York 10021 |
| Sanofi-Aventis Investigational Site Number 840050 | New York, New York 10032 |
| Sanofi-Aventis Investigational Site Number 840056 | Rochester, New York 14642 |
| Sanofi-Aventis Investigational Site Number 840015 | Syracuse, New York 13210 |
| Sanofi-Aventis Investigational Site Number 840041 | Chapel Hill, North Carolina 27599 |
| Sanofi-Aventis Investigational Site Number 840007 | Charlotte, North Carolina 28204 |
| Sanofi-Aventis Investigational Site Number 840019 | Sylvania, Ohio 43560 |
| Sanofi-Aventis Investigational Site Number 840065 | Dunmore, Pennsylvania 18512 |
| Sanofi-Aventis Investigational Site Number 840058 | Woonsocket, Rhode Island 02895 |
| Sanofi-Aventis Investigational Site Number 840052 | Charleston, South Carolina 29406 |
| Sanofi-Aventis Investigational Site Number 840002 | Knoxville, Tennessee 37920 |
| Sanofi-Aventis Investigational Site Number 840008 | Houston, Texas 77014 |
| Sanofi-Aventis Investigational Site Number 840018 | Houston, Texas 77030 |
| Sanofi-Aventis Investigational Site Number 840017 | Lubbock, Texas 79415 |
| Sanofi-Aventis Investigational Site Number 840016 | San Antonio, Texas 78229 |
| Sanofi-Aventis Investigational Site Number 840064 | Temple, Texas 76508 |
| Sanofi-Aventis Investigational Site Number 840010 | Woodlands, Texas 77380 |
| Sanofi-Aventis Investigational Site Number 840036 | Seattle, Washington 98111 |
| Sanofi-Aventis Investigational Site Number 840011 | Madison, Wisconsin 53792 |
| Sanofi-Aventis Investigational Site Number 840025 | Marshfield, Wisconsin 54449 |
| Sanofi-Aventis Investigational Site Number 840038 | Milwaukee, Wisconsin 53226 |
