A Phase III Trial of Erlotinib and Radiotherapy in Patients With Stage III Cutaneous Squamous Cell Carcinomas

Inclusion Criteria:

- Histologically proven primary or recurrent squamous cell carcinoma arising from the
lip or skin of the face, ear, scalp or neck.

- Participants must meet one of the four criteria:

- 1. T4 cutaneous SCC as determined by physical exam, imaging studies, prior resections
or biopsy. T4 disease is defined as tumor that invades deep extradermal structures
such as cartilage, skeletal muscle (e.g., muscles of facial expression), parotid
gland or bone.Patients with a T2 or greater squamous cell carcinoma of the lower lip
who will require post operative radiation will be allowed.

- 2. Histologically proven regional lymph node involvement (N1 disease). Fine needle
aspiration or biopsy can be used to demonstrate the presence of lymphatic spread.

- 3. Histologically proven parotid gland metastasis. Fine needle aspiration or biopsy
can be used to demonstrate the presence of regional spread. Includes delayed regional
metastasis; primary scalp or other skin lesion treated within 36 months that would
drain into the involved parotid.

- 4. Patients who following surgical resection of the primary are found to have
histologically positive lymph nodes (N1). Includes delayed regional metastasis;
primary lip or cutaneous lesion treated within 36 months that would drain into the
involved nodal basin.

- Age > 19 years

- Tumors must be considered surgically resectable.(Patients may be enrolled after
surgery is completed as long as Erlotinib therapy and concurrent radiation is started
within 8 weeks of surgical resection.)

- Required laboratory data obtained prior to beginning treatment: WBC > 1,500/ml;
Platelets > 90,000; serum creatinine ≤ 2.0 mg/dl

- The patient may have had a prior non-cutaneous malignancy, but must be two years from
treatment.

- Performance status of ≤ 2 (ECOG scale) and life expectancy ≥ 12 months.

- The patients must agree to use effective contraception if there is the potential for
procreativity. Contraception must be conducted for at least 3 months following the
study.

- Patients must sign informed consent

Exclusion Criteria:

- The patient has received prior radiation therapy to the head and neck.

- The patient is pregnant or lactating

- Patients with a prior history of head and neck mucosal cancers.

- Psychological condition that renders the patient unable to understand the informed
consent.