The IRESSA Novel Head and Neck Chemotherapy Evaluation Study

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Squamous Cell Cancer; Cancer of Head and Neck

Treatments: Drug: gefitinib; Drug: 5-flourouracil; Drug: cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00255476

1839IL/0544

Details and patient eligibility

About

The purpose of this study is to compare the objectie tumour response rate between the cisplatin/5FU and cisplatin/5FU plus ZD1839 combination

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of written informed consent
• Patients with histologically proven primary SCCHN
• Aged 18 or over

Exclusion criteria

• Patients eligible for surgery with curative intent
• Other co-existing malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
• Exclude UCNT

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)