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

University of California, San Diego16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-melanomatous Skin Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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