Clinical trial NCT00401323: Taxotere (Docetaxel) in 1st Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
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 Cell Carcinoma of the Head and Neck.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Head and Neck Neoplasms
Neoplasm Recurrence, Local
Neoplasm Metastasis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-11-20
Enrollment: 568
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: time to progression
timeFrame: up to 5 years
Secondary outcomes:
measure: overall survival, overall response rate (complete response + partial response), duration of response, and time to treatment failure
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: sanofi-aventis US
state: New Jersey
city: Buenos Aires
country: Argentina
facility: Sanofi-Aventis
city: Macquarie Park
country: Australia
facility: sanofi-aventis, Australia
state: New South Wales
city: Vienna
country: Austria
facility: Sanofi-Aventis
city: Diegem
country: Belgium
facility: sanofi-aventis, Belgium
city: Rio de Janeiro
country: Brazil
facility: Sanofi-Aventis
city: Laval
country: Canada
facility: sanofi-aventis Canada
state: Quebec
city: Paris
country: France
facility: sanofi-aventis, France
city: Berlin
country: Germany
facility: sanofi-aventis Germany
city: Athens
country: Greece
facility: sanofi-aventis Greece
city: Basse-Terre
country: Guadeloupe
facility: Sanofi-Aventis
city: Budapest
country: Hungary
facility: Sanofi-Aventis Hungaria
city: Natanya
country: Israel
facility: sanofi-aventis Israel
city: Milano
country: Italy
facility: sanofi-aventis Italy
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis
city: Saint-Denis
country: Réunion
facility: Sanofi-Aventis
city: Midrand
country: South Africa
facility: sanofi-aventis South Africa
city: Madrid
country: Spain
facility: Sanofi-Aventis
city: Geneva
country: Switzerland
facility: sanofi-aventis Switzerland
city: Montevideo
country: Uruguay
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: