drugset / Trial / NCT00228488

Effect of Iressa With/Without Concurrent Chemoradiotherapy on Tumor Gene Expression Profiles in Patients With Advanced Non-Nasopharyngeal Head and Neck Carcinoma

NCT00228488 ↗

Phase 2 Completed 60 enrolled AstraZeneca
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Two different patient populations will be targeted for this study. The first population (SP1) will include patients with recurrent/metastatic head and neck cancers, excluding salivary gland carcinomas. The second population (SP2) will include treatment-naïve patients with locally advanced squamous cell head and neck cancer (SCHNC). SP1 will be treated with palliative intent and the patients can be treatment-naïve or have received prior chemotherapy. Study treatment will consist of Iressa (gefitinib) alone. SP2 will be treated with radical intent. The patients must be treatment-naïve and study treatment will consist of induction Iressa for 3 weeks followed by a combination of Iressa plus cisplatin and concurrent irradiation.

Timeline

Start
2004-06
Primary completion
—
Completion
2005-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Gefitinib Small molecule — —

Indications