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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized Phase II-III Multicenter Trial of Docetaxel Plus Cisplatin and Docetaxel Plus 5-FU Versus Cisplatin Plus 5-FU in 1st Line Treatment of Patients With Recurrent and/or Metastatic Squamous C

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

Detailed Summary:
Sponsor: Sanofi

Current Primary Outcome: time to progression [ Time Frame: up to 5 years ]

Original Primary Outcome: Primary efficacy data: time to progression

Current Secondary Outcome: overall survival, overall response rate (complete response + partial response), duration of response, and time to treatment failure [ Time Frame: up to 5 years ]

Original Secondary Outcome: Secondary efficacy data: overall survival, overall response rate (complete response + partial response), duration of response, and time to treatment failure

Information By: Sanofi

Dates:
Date Received: November 17, 2006
Date Started: January 1998
Date Completion:
Last Updated: January 19, 2011
Last Verified: January 2011