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

Sanofi568 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

568

Conditions

Head and Neck Neoplasms Neoplasm Recurrence, Local Neoplasm Metastasis

Interventions

docetaxel (XRP6976)DRUG

cisplatinDRUG

5-fluorouracil (5-FU)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (20)

sanofi-aventis US

Bridgewater, New Jersey, United States

Sanofi-Aventis

Buenos Aires, Argentina

Outcomes

Primary Outcomes

time to progression

Time frame: up to 5 years

Secondary Outcomes

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

Time frame: up to 5 years

Data from ClinicalTrials.gov

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