Gefitinib (Iressa) in Combo With Chemoradiation in Patients With Locally Advanced Head & Neck Cancer

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine the safety and tolerability of gefitinib in combination with cisplatin and radiation (3D-CRT or IMRT) in patients with locally advanced head and neck cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Cisplatin; Gefitinib

Criteria

Inclusion Criteria:

• Histologically confirmed head and neck cancer

• Lymph node negative or positive

• Metastasis negative

• Chemo- and radiotherapy naïve

• WHO 0-2

• Measurable disease by RECIST

• Written informed consent

Exclusion Criteria:

• Severe alcohol abuse

• Active ILD

• Co-existing chronic gastrointestinal disease(s)

• Brain metastasis