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

This study has been completed.

First Received: November 17, 2006 Last Updated: March 24, 2009 History of Changes

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00401323

Purpose

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.

Condition	Intervention	Phase
Head and Neck Neoplasms Neoplasm Recurrence, Local Neoplasm Metastasis	Drug: docetaxel (XRP6976)	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Docetaxel

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Primary efficacy data: time to progression

Secondary Outcome Measures:

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

Estimated Enrollment:	642
Study Start Date:	January 1998

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401323

Show 20 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	EFC6051, XRP6976G-322
Study First Received:	November 17, 2006
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00401323 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Carcinoma, Squamous Cell of Head and Neck
Squamous Cell Carcinoma
Recurrence
Carcinoma
Docetaxel
Cisplatin
Head and Neck Neoplasms

Fluorouracil
Epidermoid Carcinoma
Neoplasm Metastasis
Neoplasm Recurrence, Local
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Disease Attributes
Neoplasms by Histologic Type
Antineoplastic Agents
Pharmacologic Actions
Recurrence
Carcinoma
Docetaxel
Neoplasms
Neoplastic Processes

Neoplasms by Site
Pathologic Processes
Therapeutic Uses
Head and Neck Neoplasms
Neoplasm Metastasis
Neoplasm Recurrence, Local
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 03, 2009