drugset / Trial / NCT00412217

A Study of Erlotinib (Tarceva) in Participants With Resected Head and Neck Squamous Cell Cancer

NCT00412217

Phase 3 Terminated 94 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

Summary

This two-arm study will compare the efficacy and safety of erlotinib (Tarceva) versus placebo in participants with resected head and neck squamous cell cancer who are receiving concurrent chemoradiotherapy or radiotherapy alone. Participants will be randomized to receive either erlotinib 150 milligrams (mg) orally (PO) once daily or placebo for 1 year until disease progression or unacceptable toxicity.

Timeline

Start
2006-11
Primary completion
2009-12
Completion
2009-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Erlotinib Small molecule 150 mg Oral