Status:
COMPLETED
Taxotere (Docetaxel) in 1st Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Lead Sponsor:
Sanofi
Conditions:
Head and Neck Neoplasms
Neoplasm Recurrence, Local
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of the study is to compare time to progression and overall survival after treatment with Taxotere plus cisplatin versus cisplatin plus 5-FU (PF treatment group) in the first line treatment...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients with histologically or cytologically documented squamous cell carcinoma of the head and neck (SCCHN) (eligible primary sites: oral cavity, oropharynx, hypopharyx, or larynx) presenting with locally recurrent and/or metastatic disease, with at least 1 unidimensionally or bidimensionally measurable lesion.
Exclusion
Key Trial Info
Start Date :
January 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2003
Estimated Enrollment :
568 Patients enrolled
Trial Details
Trial ID
NCT00401323
Start Date
January 1 1998
End Date
June 1 2003
Last Update
January 20 2011
Active Locations (20)
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1
sanofi-aventis US
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis
Buenos Aires, Argentina
3
sanofi-aventis, Australia
Macquarie Park, New South Wales, Australia
4
Sanofi-Aventis
Vienna, Austria