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

AstraZeneca

Status and phase: Completed; Phase 2; Phase 1

Conditions: Head and Neck Neoplasms

Treatments: Drug: Cisplatin; Procedure: Radiotherapy; Drug: Gefitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00239304

1839IL/0151

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)