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

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.

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Neoplasms; Neoplasm Metastasis; Neoplasm Recurrence, Local
• Intervention / Treatment: Drug: cisplatin; Drug: docetaxel (XRP6976); Drug: 5-fluorouracil (5-FU)

• Study Type: Interventional
• Enrollment (Actual): 568
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: cisplatin; Drug: docetaxel (XRP6976); Other Names: Taxotere
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 Names: Taxotere; Drug: 5-fluorouracil (5-FU)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
time to progression	up to 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival, overall response rate (complete response + partial response), duration of response, and time to treatment failure	up to 5 years

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: January 1, 1998
• Primary Completion (Actual): June 1, 2003
• Study Completion (Actual): June 1, 2003

Study Registration Dates

• First Submitted: November 17, 2006
• First Submitted That Met QC Criteria: November 17, 2006
• First Posted (Estimate): November 20, 2006

Study Record Updates

• Last Update Posted (Estimate): January 20, 2011
• Last Update Submitted That Met QC Criteria: January 19, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Disease Attributes; Neoplastic Processes; Neoplasms, Squamous Cell; Neoplasms; Head and Neck Neoplasms; Neoplasm Metastasis; Recurrence; Carcinoma, Squamous Cell; Neoplasm Recurrence, Local; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Cisplatin; Fluorouracil
• Other Study ID Numbers: EFC6051; XRP6976G-322