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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Non-melanomatous Skin Cancer

Intervention / Treatment
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* Biological: PEG-interferon alfa-2a
* Drug: gefitinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: PEG-interferon alfa-2a|nan|
|Drug: gefitinib|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability |  |  | 
| Response rate to treatment with gefitinib alone for 1 month |  |  | 
| Response rate to treatment with gefitinib in combination with PEG-interferon alfa-2a |  |  | 
| Toxicity |  |  | 
| Quantification of rash after treatment with gefitinib for 1 month and after the addition of PEG-interferon alfa-2a to gefitinib |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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squamous cell carcinoma of the skin, recurrent skin cancer