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

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ClinicalTrials.gov Identifier: NCT00401323
Recruitment Status : Completed
First Posted : November 20, 2006
Last Update Posted : January 20, 2011
Sponsor:
Information provided by:
Sanofi

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.

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 568 participants
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.
Study Start Date : January 1998
Actual Primary Completion Date : June 2003
Actual Study Completion Date : June 2003

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U.S. FDA Resources

Arm Intervention/treatment
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)



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

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


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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.


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


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Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi

Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00401323     History of Changes
Other Study ID Numbers: EFC6051
XRP6976G-322
First Posted: November 20, 2006    Key Record Dates
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