Overview

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

Status:
Completed

Trial end date:
2003-06-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2/Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Sanofi

Treatments:

Cisplatin
Docetaxel
Fluorouracil

Criteria

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.