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

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00401323

Collaborator

(none)

568

Enrollment

Locations

Arms

Duration (Months)

28.4

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Jan 1, 1998

Actual Primary Completion Date :

Jun 1, 2003

Actual Study Completion Date :

Jun 1, 2003

Arms and Interventions

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 Names: 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 Names: Taxotere Drug: 5-fluorouracil (5-FU)

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 Names:

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 Names:

Taxotere

Drug: 5-fluorouracil (5-FU)

Outcome Measures

Primary Outcome Measures

time to progression [up to 5 years]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	sanofi-aventis US	Bridgewater	New Jersey	United States	08807
2	Sanofi-Aventis	Buenos Aires		Argentina
3	sanofi-aventis, Australia	Macquarie Park	New South Wales	Australia
4	Sanofi-Aventis	Vienna		Austria
5	sanofi-aventis, Belgium	Diegem		Belgium
6	Sanofi-Aventis	Rio de Janeiro		Brazil
7	sanofi-aventis Canada	Laval	Quebec	Canada
8	sanofi-aventis, France	Paris		France
9	sanofi-aventis Germany	Berlin		Germany
10	sanofi-aventis Greece	Athens		Greece
11	Sanofi-Aventis	Basse-Terre		Guadeloupe
12	Sanofi-Aventis Hungaria	Budapest		Hungary
13	sanofi-aventis Israel	Natanya		Israel
14	sanofi-aventis Italy	Milano		Italy
15	Sanofi-Aventis	Moscow		Russian Federation
16	Sanofi-Aventis	Saint-Denis		Réunion
17	sanofi-aventis South Africa	Midrand		South Africa
18	Sanofi-Aventis	Madrid		Spain
19	sanofi-aventis Switzerland	Geneva		Switzerland
20	Sanofi-Aventis	Montevideo		Uruguay