A Phase I/II Pilot Study of Bioimmunotherapy With IRESSA (Gefitinib) and Pegylated Interferon Alpha-2a for Patients With Unresectable/Metastatic Squamous Cell Carcinoma of the Skin

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed primary squamous cell carcinoma of the skin

- Metastatic and/or unresectable locally recurrent disease

- Measurable disease

- No curative treatment option (including resection and radiotherapy) exists or is
unacceptably morbid

PATIENT CHARACTERISTICS:

- WHO performance status 0-2

- Absolute neutrophil count > 1,500/mm³

- Platelet count > 100,000/mm³

- Bilirubin < 1.5 times upper limit of normal

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV/AIDS allowed

- Patients with other cancer diagnoses (e.g., chronic lymphocytic leukemia) are
eligible provided disease is controlled and does not require active treatment

- No pre-existing medical problems or laboratory abnormalities ≥ grade 3 except renal
allograft patients with chronic, stable grade 3-4 renal insufficiency who are
dialysis candidates

- Nontransplant patients with any degree of renal insufficiency allowed

- No serious medical or psychiatric illness that would preclude study compliance

- No evidence of severe or uncontrolled (≥ grade 3) systemic disease (e.g., unstable or
uncompensated respiratory, cardiac, or hepatic disease)

PRIOR CONCURRENT THERAPY:

- Prior solid organ transplant allowed

- Prior cytotoxic chemotherapy and radiotherapy allowed

- More than 30 days since prior experimental cancer treatment

- No prior epidermal growth factor receptor-inhibiting drugs, including gefitinib,
erlotinib hydrochloride, or cetuximab

- No concurrent radiotherapy

- No concurrent cytotoxic chemotherapy or other drugs intended to control skin cancer