gefitinib and peg-interferon alfa-2a in treating patients with unresectable or metastatic skin cancer

Conditions: Non-melanomatous Skin Cancer

Summary: rationale: gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. peg-interferon alfa-2a may interfere with the growth of tumor cells and slow the growth of skin cancer. giving gefitinib together with peg-interferon alfa-2a may kill more tumor cells. purpose: this phase i/ii trial is studying the side effects and best dose of peg-interferon alfa-2a when given together with gefitinib and to see how well they work in treating patients with unresectable or metastatic skin cancer.

objectives: * determine the tolerability of gefitinib and peg-interferon alfa-2a in patients with unresectable or metastatic squamous cell carcinoma of the skin. * determine the response rate in patients treated with gefitinib for 1 month. * determine whether the addition of weekly peg-interferon alfa-2a to ongoing gefitinib improves response rate in these patients . * determine whether peg-interferon alfa-2a exacerbates rash in patients who have been treated with gefitinib for 1 month. outline: this is a phase i, pilot, dose de-escalation study of peg-interferon alfa-2a followed by an open-label, phase ii study. * phase i: patients receive oral gefitinib alone once daily for 4 weeks. beginning in week 5, patients also receive peg-interferon alfa-2a subcutaneously once weekly. treatment continues in the absence of disease progression or unacceptable toxicity. cohorts of patients receive de-escalating doses of peg-interferon alfa-2a until a tolerable dose is determined. * phase ii: patients receive gefitinib and peg-interferon alfa-2a at the tolerable dose determined in phase i. projected accrual: a total of 16 patients will be accrued for this study.

Eligibility 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

Keywords: squamous cell carcinoma of the skin recurrent skin cancer