Phase II Study of Skin Toxicity Dosing of IRESSA (Gefitinib) as Monotherapy in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

Inclusion Criteria:

- squamous cell carcinoma of the head and neck

- Tumour site that is amenable to biopsy. Patients can refuse biopsy and still
participate in the study but all patients must have disease that can be biopsied

- Aged 18 years or older

- Prior EGFR-based therapy is allowed if greater than 4 months have elapsed since last
dose of that agent and study entry

- No chemotherapy or irradiation within the 28-day period preceding entry to the study.

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Ability to understand and the willingness to sign a written informed consent
document.

- Normal organ and marrow function

Exclusion Criteria:

- Known severe hypersensitivity to Iressa or any of the excipients of this product

- Other co-existing malignancies or malignancies diagnosed within the last 3 years with
the exception of basal cell carcinoma or cervical cancer in situ

- Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer
therapy (except alopecia).

- Evidence of any other significant clinical disorder or laboratory finding that makes
it undesirable for the subject to participate in the trial

- Pregnancy or breast feeding women

- Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's
Wort

- Treatment with a non-approved or investigational drug within 30 days before Day 1 of
study treatment

- Any evidence of clinically active interstitial lung disease