Taxotere (Docetaxel) in 1st Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Completed · Phase 2/Phase 3

Conditions studied: Head and Neck Neoplasms, Neoplasm Recurrence, Local, Neoplasm Metastasis

In brief

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 of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.

Key facts

Study ID

NCT00401323

Run by

Sanofi

People needed

568

Starts

1998-01-01

Expected to finish

2003-06-01

Last updated by the study team

2011-01-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• sanofi-aventis US — Bridgewater, New Jersey, United States
• Sanofi-Aventis — Buenos Aires, Argentina
• sanofi-aventis, Australia — Macquarie Park, New South Wales, Australia
• Sanofi-Aventis — Vienna, Austria
• sanofi-aventis, Belgium — Diegem, Belgium
• Sanofi-Aventis — Rio de Janeiro, Brazil
• sanofi-aventis Canada — Laval, Quebec, Canada
• sanofi-aventis, France — Paris, France
• sanofi-aventis Germany — Berlin, Germany
• sanofi-aventis Greece — Athens, Greece
• Sanofi-Aventis — Basse-Terre, Guadeloupe
• Sanofi-Aventis Hungaria — Budapest, Hungary
• sanofi-aventis Israel — Netanya, Israel
• sanofi-aventis Italy — Milan, Italy
• Sanofi-Aventis — Saint-Denis, Reunion
• Sanofi-Aventis — Moscow, Russia
• sanofi-aventis South Africa — Midrand, South Africa
• Sanofi-Aventis — Madrid, Spain
• sanofi-aventis Switzerland — Geneva, Switzerland
• Sanofi-Aventis — Montevideo, Uruguay

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.