MedTrace Logo

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

NCT00401323 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 568

Last updated 2011-01-20

No results posted yet for this study

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.

Conditions

  • Head and Neck Neoplasms
  • Neoplasm Recurrence, Local
  • Neoplasm Metastasis

Interventions

DRUG

docetaxel (XRP6976)

DRUG

cisplatin

DRUG

5-fluorouracil (5-FU)

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-01-31
Primary Completion
2003-06-30
Completion
2003-06-30

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • France
  • Germany
  • Greece
  • Guadeloupe
  • Hungary
  • Israel
  • Italy
  • Reunion
  • Russia
  • South Africa
  • Spain
  • Switzerland
  • Uruguay

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00401323 on ClinicalTrials.gov