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.

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00401323

Enrollment

568

Registered

2006-11-20

Start date

1998-01-31

Completion date

2003-06-30

Last updated

2011-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGdocetaxel (XRP6976)

DRUGcisplatin

DRUG5-fluorouracil (5-FU)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
time to progression	up to 5 years

Secondary

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

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026