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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00401323
First Posted: November 20, 2006
Last Update Posted: January 20, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  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) Drug: cisplatin Drug: 5-fluorouracil (5-FU) Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • time to progression [ Time Frame: up to 5 years ]

Secondary Outcome Measures:
  • overall survival, overall response rate (complete response + partial response), duration of response, and time to treatment failure [ Time Frame: up to 5 years ]

Enrollment: 568
Study Start Date: January 1998
Study Completion Date: June 2003
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: docetaxel (XRP6976)
Other Name: Taxotere
Drug: cisplatin
Active Comparator: 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
Drug: cisplatin Drug: 5-fluorouracil (5-FU)
Experimental: 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

Drug: docetaxel (XRP6976)
Other Name: Taxotere
Drug: 5-fluorouracil (5-FU)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00401323


  Show 20 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00401323     History of Changes
Other Study ID Numbers: EFC6051
XRP6976G-322
First Submitted: November 17, 2006
First Posted: November 20, 2006
Last Update Posted: January 20, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Neoplasms
Carcinoma, Squamous Cell
Recurrence
Neoplasm Metastasis
Head and Neck Neoplasms
Neoplasm Recurrence, Local
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Disease Attributes
Pathologic Processes
Neoplastic Processes
Neoplasms by Site
Docetaxel
Cisplatin
Fluorouracil
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs