IRESSA in combination with Cisplatin & Radiotherapy in Patients with Advanced Head & Neck Carcinoma

Exclusion Criteria

• - 1. Previous treatment for initial disease (neck dissection in N3 is allowed)
• 2. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
• 3. Incomplete healing from previous oncologic or other surgery
• 4. Absolute neutrophil count (ANC) less than 1.5 x 109/ L, or platelets less than 100x 109/L
• 5. Serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR)
• 6. In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
• 7. Serum creatinine greater than 1.25 times the ULRR
• 8. ALT or AST greater than 2.5 times the ULRR
• 9. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial
• 10. Active dermatoses (e.g. psoriasis, eczema)
• 11. Corneal abnormalities (other than scars, congenital abnormality or corneal tear film), history of dry eye syndrome or ocular surface diseases and neurological disorders
• 12. Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin or drugs with known corneal toxicity
• 13. Pregnancy or breastfeeding (women of child-bearing potential)
• 14. Patient incapacity to reliably follow the treatment or follow up for family, economic or geographical reasons.