drugset / Trial / NCT00229723

IRESSA™ (Gefitinib) With Cisplatin Plus Radiotherapy for the Treatment of Previously Untreated Unresected Late Stage III/IV Non-Metastatic Head and Neck Squamous Cell Carcinoma

NCT00229723 ↗

Phase 2 Completed 224 enrolled AstraZeneca
RandomizedFactorialQuadruple-blindTreatment

Summary

The primary purpose of this study is to assess the effectiveness of ZD1839 250 mg and 500 mg when given either concomitantly or as maintenance to a standard therapy of radiotherapy (X-rays) plus chemotherapy (cisplatin) in terms of local disease control (progression-free) rate at 2 years.

Timeline

Start
2004-11
Primary completion
—
Completion
2008-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Gefitinib Small molecule 250 mg Oral
Subject Gefitinib Small molecule 500 mg Oral
Background Cisplatin Other / unclassified — Intravenous