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

Primary Purpose

Head and Neck Neoplasms, Neoplasm Recurrence, Local, Neoplasm Metastasis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
docetaxel (XRP6976)
cisplatin
5-fluorouracil (5-FU)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • sanofi-aventis US
  • Sanofi-Aventis
  • sanofi-aventis, Australia
  • Sanofi-Aventis
  • sanofi-aventis, Belgium
  • Sanofi-Aventis
  • sanofi-aventis Canada
  • sanofi-aventis, France
  • sanofi-aventis Germany
  • sanofi-aventis Greece
  • Sanofi-Aventis
  • Sanofi-Aventis Hungaria
  • sanofi-aventis Israel
  • sanofi-aventis Italy
  • Sanofi-Aventis
  • Sanofi-Aventis
  • sanofi-aventis South Africa
  • Sanofi-Aventis
  • sanofi-aventis Switzerland
  • Sanofi-Aventis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

docetaxel plus cisplatin

cisplatin plus 5-FU

docetaxel plus 5-FU

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

time to progression

Secondary Outcome Measures

overall survival, overall response rate (complete response + partial response), duration of response, and time to treatment failure

Full Information

First Posted
November 17, 2006
Last Updated
January 19, 2011
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00401323
Brief Title
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

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
January 1998 (undefined)
Primary Completion Date
June 2003 (Actual)
Study Completion Date
June 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms, Neoplasm Recurrence, Local, Neoplasm Metastasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
568 (Actual)

8. Arms, Groups, and Interventions

Arm Title
docetaxel plus cisplatin
Arm Type
Experimental
Arm Description
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
Arm Title
cisplatin plus 5-FU
Arm Type
Active Comparator
Arm Description
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
Arm Title
docetaxel plus 5-FU
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
docetaxel (XRP6976)
Other Intervention Name(s)
Taxotere
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil (5-FU)
Primary Outcome Measure Information:
Title
time to progression
Time Frame
up to 5 years
Secondary Outcome Measure Information:
Title
overall survival, overall response rate (complete response + partial response), duration of response, and time to treatment failure
Time Frame
up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
sanofi-aventis US
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Sanofi-Aventis
City
Buenos Aires
Country
Argentina
Facility Name
sanofi-aventis, Australia
City
Macquarie Park
State/Province
New South Wales
Country
Australia
Facility Name
Sanofi-Aventis
City
Vienna
Country
Austria
Facility Name
sanofi-aventis, Belgium
City
Diegem
Country
Belgium
Facility Name
Sanofi-Aventis
City
Rio de Janeiro
Country
Brazil
Facility Name
sanofi-aventis Canada
City
Laval
State/Province
Quebec
Country
Canada
Facility Name
sanofi-aventis, France
City
Paris
Country
France
Facility Name
sanofi-aventis Germany
City
Berlin
Country
Germany
Facility Name
sanofi-aventis Greece
City
Athens
Country
Greece
Facility Name
Sanofi-Aventis
City
Basse-Terre
Country
Guadeloupe
Facility Name
Sanofi-Aventis Hungaria
City
Budapest
Country
Hungary
Facility Name
sanofi-aventis Israel
City
Natanya
Country
Israel
Facility Name
sanofi-aventis Italy
City
Milano
Country
Italy
Facility Name
Sanofi-Aventis
City
Moscow
Country
Russian Federation
Facility Name
Sanofi-Aventis
City
Saint-Denis
Country
Réunion
Facility Name
sanofi-aventis South Africa
City
Midrand
Country
South Africa
Facility Name
Sanofi-Aventis
City
Madrid
Country
Spain
Facility Name
sanofi-aventis Switzerland
City
Geneva
Country
Switzerland
Facility Name
Sanofi-Aventis
City
Montevideo
Country
Uruguay

12. IPD Sharing Statement

Learn more about this trial

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

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