drugset / Trial / NCT00261703

Docetaxel in Head and Neck Cancer

NCT00261703

Phase 2/3 Completed 439 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

Summary

Primary Objective: * Phase II: To determine the best treatment scheme (TPF vs. PF). * Phase III: To compare the time to progression and the treatment failure at the 3 arms. Secondary objectives: * To evaluate the safety at the 3 arms. * To compare the progression , overall survival and locoregional control at the 3 arms.

Timeline

Start
2002-12
Primary completion
2010-07
Completion
2010-07

Drugs

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