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

Neoplasm Metastasis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00401323
• Other study ID #: EFC6051
• Secondary ID: XRP6976G-322
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 17, 2006
• Last updated: January 19, 2011
• Start date: January 1998
• Est. completion date: June 2003

Study information

• Verified date: January 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 568
• Est. completion date: June 2003
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Neoplasm Metastasis
• Neoplasm Recurrence, Local
• Neoplasms
• Recurrence

Intervention

Drug:
• docetaxel (XRP6976)

• cisplatin

• 5-fluorouracil (5-FU)

Locations

Country	Name	City	State
Argentina	Sanofi-Aventis	Buenos Aires
Australia	sanofi-aventis, Australia	Macquarie Park	New South Wales
Austria	Sanofi-Aventis	Vienna
Belgium	sanofi-aventis, Belgium	Diegem
Brazil	Sanofi-Aventis	Rio de Janeiro
Canada	sanofi-aventis Canada	Laval	Quebec
France	sanofi-aventis, France	Paris
Germany	sanofi-aventis Germany	Berlin
Greece	sanofi-aventis Greece	Athens
Guadeloupe	Sanofi-Aventis	Basse-Terre
Hungary	Sanofi-Aventis Hungaria	Budapest
Israel	sanofi-aventis Israel	Natanya
Italy	sanofi-aventis Italy	Milano
Réunion	Sanofi-Aventis	Saint-Denis
Russian Federation	Sanofi-Aventis	Moscow
South Africa	sanofi-aventis South Africa	Midrand
Spain	Sanofi-Aventis	Madrid
Switzerland	sanofi-aventis Switzerland	Geneva
United States	sanofi-aventis US	Bridgewater	New Jersey
Uruguay	Sanofi-Aventis	Montevideo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Uruguay,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  France,  Germany,  Greece,  Guadeloupe,  Hungary,  Israel,  Italy,  Russian Federation,  Réunion,  South Africa,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to progression		up to 5 years	No
Secondary	overall survival, overall response rate (complete response + partial response), duration of response, and time to treatment failure		up to 5 years	No