ZD1839 (IRESSA™) in combination with docetaxel & cisplatin in subjects with metastatic head & neck cancer

Exclusion Criteria

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• 1. Previous chemotherapy for recurrent or metastatic disease
• 2. Less than 6 months since prior induction or adjuvant platinum and/or taxanes chemotherapy
• 3. Known severe hypersensitivity to ZD1839 or any of the excipients of this product
• 4. Known, severe hypersensitivity to docetaxel or cisplatin or any of the excipients of these products, or to other drugs formulated with polysorbate 80
• 5. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
• 6. Any unresolved chronic toxicity greater than common toxicity criteria (CTC) grade 2 from previous anticancer therapy (except alopecia)
• 7. Absolute neutrophil count (ANC) less than 1.5 x109/litre (L), platelets less than 100 x 109/L or haemoglobin less than 10 g/dl
• 8. Serum bilirubin greater than the upper limit of the reference range (ULRR)
• 9. Serum creatinine greater than 1.5 mg/dl despite adequate rehydration
• 10. Creatinine clearance less than 60 ml/min assessed in over a 24 hour urine collection
• 11. As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
• 12. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 1.5 times the ULRR or alkaline phosphatase (ALP) greater than 2.5 times the ULRR
• 13. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
• 14. Pregnancy or breast feeding (women of child-bearing potential)
• 15. Concomitant use of phenytoin, carbamazepine, rifampicin, or barbiturates, or St John’s Wort
• 16. Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment
• 17. Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded