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

Phase 2

Completed

• Conditions: Head and Neck Neoplasms; Neoplasm Recurrence, Local; Neoplasm Metastasis
• Interventions: Drug: docetaxel (XRP6976); Drug: cisplatin; Drug: 5-fluorouracil (5-FU)

• Registration Number: NCT00401323
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-01
• Primary Completion: 2003-06
• Study Completion: 2003-06
• Study First Submitted: 2006-11-17
• Study First Submitted QC: 2006-11-17
• Study First Posted: 2006-11-20
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-19
• Last Update Posted: 2011-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 568

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
docetaxel plus cisplatin	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
cisplatin plus 5-FU	cisplatin	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
docetaxel plus cisplatin	docetaxel (XRP6976)	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
cisplatin plus 5-FU	5-fluorouracil (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
docetaxel plus 5-FU	docetaxel (XRP6976)	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
docetaxel plus 5-FU	5-fluorouracil (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

Primary Outcome Measures

Name	Time	Method
time to progression	up to 5 years

Secondary Outcome Measures

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

Trial Locations

Locations (13)

sanofi-aventis South Africa; 🇿🇦 Midrand, South Africa

sanofi-aventis, France; 🇫🇷 Paris, France

Sanofi-Aventis Hungaria; 🇭🇺 Budapest, Hungary

sanofi-aventis Germany; 🇩🇪 Berlin, Germany

sanofi-aventis Switzerland; 🇨🇭 Geneva, Switzerland

sanofi-aventis Italy; 🇮🇹 Milano, Italy

sanofi-aventis, Australia; 🇦🇺 Macquarie Park, New South Wales, Australia

sanofi-aventis, Belgium; 🇧🇪 Diegem, Belgium

sanofi-aventis Israel; 🇮🇱 Natanya, Israel

sanofi-aventis Canada; 🇨🇦 Laval, Quebec, Canada

sanofi-aventis Greece; 🇬🇷 Athens, Greece

Sanofi-Aventis; 🇺🇾 Montevideo, Uruguay

sanofi-aventis US; 🇺🇸 Bridgewater, New Jersey, United States