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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00401323
First received: November 17, 2006
Last updated: January 19, 2011
Last verified: January 2011

November 17, 2006
January 19, 2011
January 1998
June 2003   (final data collection date for primary outcome measure)
time to progression [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
Primary efficacy data: time to progression
Complete list of historical versions of study NCT00401323 on ClinicalTrials.gov Archive Site
overall survival, overall response rate (complete response + partial response), duration of response, and time to treatment failure [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
Secondary efficacy data: overall survival, overall response rate (complete response + partial response), duration of response, and time to treatment failure
Not Provided
Not Provided
 
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.

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Head and Neck Neoplasms
  • Neoplasm Recurrence, Local
  • Neoplasm Metastasis
  • Drug: docetaxel (XRP6976)
    Other Name: Taxotere
  • Drug: cisplatin
  • Drug: 5-fluorouracil (5-FU)
  • 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
    Interventions:
    • Drug: docetaxel (XRP6976)
    • 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
    Interventions:
    • 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

    Interventions:
    • Drug: docetaxel (XRP6976)
    • Drug: 5-fluorouracil (5-FU)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
568
June 2003
June 2003   (final data collection date for primary outcome measure)

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.

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   France,   Germany,   Greece,   Guadeloupe,   Hungary,   Israel,   Italy,   Russian Federation,   Réunion,   South Africa,   Spain,   Switzerland,   Uruguay
 
NCT00401323
EFC6051, XRP6976G-322
Not Provided
Trial Transparency Team, sanofi-aventis
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP