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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

568 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-01-31

Study Completion Date

2003-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Head and Neck Neoplasms Neoplasm Recurrence, Local Neoplasm Metastasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

docetaxel (XRP6976)

Intervention Type DRUG

cisplatin

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

cisplatin

Intervention Type DRUG

5-fluorouracil (5-FU)

Intervention Type DRUG

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

Group Type EXPERIMENTAL

docetaxel (XRP6976)

Intervention Type DRUG

5-fluorouracil (5-FU)

Intervention Type DRUG

Interventions

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docetaxel (XRP6976)

Intervention Type DRUG

cisplatin

Intervention Type DRUG

5-fluorouracil (5-FU)

Intervention Type DRUG

Other Intervention Names

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Taxotere

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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sanofi-aventis

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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sanofi-aventis US

Bridgewater, New Jersey, United States

Site Status

Sanofi-Aventis

Buenos Aires, , Argentina

Site Status

sanofi-aventis, Australia

Macquarie Park, New South Wales, Australia

Site Status

Sanofi-Aventis

Vienna, , Austria

Site Status

sanofi-aventis, Belgium

Diegem, , Belgium

Site Status

Sanofi-Aventis

Rio de Janeiro, , Brazil

Site Status

sanofi-aventis Canada

Laval, Quebec, Canada

Site Status

sanofi-aventis, France

Paris, , France

Site Status

sanofi-aventis Germany

Berlin, , Germany

Site Status

sanofi-aventis Greece

Athens, , Greece

Site Status

Sanofi-Aventis

Basse-Terre, , Guadeloupe

Site Status

Sanofi-Aventis Hungaria

Budapest, , Hungary

Site Status

sanofi-aventis Israel

Netanya, , Israel

Site Status

sanofi-aventis Italy

Milan, , Italy

Site Status

Sanofi-Aventis

Saint-Denis, , Reunion

Site Status

Sanofi-Aventis

Moscow, , Russia

Site Status

sanofi-aventis South Africa

Midrand, , South Africa

Site Status

Sanofi-Aventis

Madrid, , Spain

Site Status

sanofi-aventis Switzerland

Geneva, , Switzerland

Site Status

Sanofi-Aventis

Montevideo, , Uruguay

Site Status

Countries

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United States Argentina Australia Austria Belgium Brazil Canada France Germany Greece Guadeloupe Hungary Israel Italy Reunion Russia South Africa Spain Switzerland Uruguay