drugset / Trial / NCT00401323

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

NCT00401323

Phase 2/3 Completed 568 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
1998-01
Primary completion
2003-06
Completion
2003-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 75 mg/m2
Subject Cisplatin Other / unclassified 100 mg/m2
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Docetaxel Small molecule 85 mg/m2 Intravenous
Subject fluorouracil Small molecule 750 mg/m2
Subject fluorouracil Small molecule 1000 mg/m2