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

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: November 17, 2006
Last updated: January 19, 2011
Last verified: January 2011

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.

Condition Intervention Phase
Head and Neck Neoplasms
Neoplasm Recurrence, Local
Neoplasm Metastasis
Drug: docetaxel (XRP6976)
Drug: cisplatin
Drug: 5-fluorouracil (5-FU)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • time to progression [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival, overall response rate (complete response + partial response), duration of response, and time to treatment failure [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]

Enrollment: 568
Study Start Date: January 1998
Study Completion Date: June 2003
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: docetaxel plus cisplatin
Taxotere 75 mg/m², one-hour IV infusion on Day 1 of each 3-week cycle followed by cisplatin 75 mg/m² administered as a 30-minute to 3-hour infusion on Day 1
Drug: docetaxel (XRP6976)
Other Name: Taxotere
Drug: cisplatin
Active Comparator: cisplatin plus 5-FU
Cisplatin 100 mg/m², 30-minute to 3-hour infusion on Day 1 of each 3-week cycle followed by the continuous infusion of 5-FU 1000 mg/m²/day from Day 1 to Day 5
Drug: cisplatin Drug: 5-fluorouracil (5-FU)
Experimental: docetaxel plus 5-FU

Taxotere 85 mg/m², one-hour IV infusion on Day 1 of each 3-week cycle followed by the continuous infusion of 5-FU 750 mg/m²/day from Day 1 to Day 5

Arm only in the phase II part of the study

Drug: docetaxel (XRP6976)
Other Name: Taxotere
Drug: 5-fluorouracil (5-FU)


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
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Please refer to this study by its identifier: NCT00401323

  Hide Study Locations
United States, New Jersey
sanofi-aventis US
Bridgewater, New Jersey, United States, 08807
Buenos Aires, Argentina
Australia, New South Wales
sanofi-aventis, Australia
Macquarie Park, New South Wales, Australia
Vienna, Austria
sanofi-aventis, Belgium
Diegem, Belgium
Rio de Janeiro, Brazil
Canada, Quebec
sanofi-aventis Canada
Laval, Quebec, Canada
sanofi-aventis, France
Paris, France
sanofi-aventis Germany
Berlin, Germany
sanofi-aventis Greece
Athens, Greece
Basse-Terre, Guadeloupe
Sanofi-Aventis Hungaria
Budapest, Hungary
sanofi-aventis Israel
Natanya, Israel
sanofi-aventis Italy
Milano, Italy
Russian Federation
Moscow, Russian Federation
Saint-Denis, Réunion
South Africa
sanofi-aventis South Africa
Midrand, South Africa
Madrid, Spain
sanofi-aventis Switzerland
Geneva, Switzerland
Montevideo, Uruguay
Sponsors and Collaborators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Trial Transparency Team, sanofi-aventis Identifier: NCT00401323     History of Changes
Other Study ID Numbers: EFC6051, XRP6976G-322
Study First Received: November 17, 2006
Last Updated: January 19, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasm Metastasis
Neoplasm Recurrence, Local
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Neoplastic Processes
Pathologic Processes
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators processed this record on March 26, 2015