Gefitinib and PEG-Interferon Alfa-2a in Treating Patients With Unresectable or Metastatic Skin Cancer

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