Squamous Cell Carcinoma of the Skin Clinical Trial
Official title:
A Phase II Study of ZD1839 and Radiation in Patients With Squamous Cell Carcinoma of the Skin
The goal of this clinical research study is to learn if giving Iressa (Gefitinib or ZD1839) with surgery and/or radiation will help to control squamous cell carcinoma of the skin. The safety of this treatment will also be studied
PRIMARY OBJECTIVES:
I. Early progression rate (progression during ZD1839 induction).
II. Feasibility of induction ZD1839 (for all patients) and concomitant ZD1839 with
radiotherapy (for unresectable patients).
III. Toxicities of induction ZD1839 (for all patients) and concomitant ZD1839 with
radiotherapy (for unresectable patients).
SECONDARY OBJECTIVES:
I. Response: clinical responses to induction therapy.
II. Failures: frequency and timing of local and distant failures.
III. Biomarkers: biomarker levels in tumor and normal tissue.
TERTIARY OBJECTIVES:
I. For progressive disease responders, patients will be followed for locoregional and distant
metastases data.
II. Feasibility of maintenance ZD1839.
III. Toxicities of maintenance ZD1839.
OUTLINE: Patients are assigned to 1 of 2 groups.
STRATUM I (initially resectable tumor): Patients undergo radiotherapy once daily (QD) 5 days
a week for approximately 6-7 weeks. Patients also receive gefitinib orally (PO) QD for up to
12 months
STRATUM II (initially unresectable tumor): Patients undergo radiotherapy QD 5 days a week for
approximately 6-7 weeks. Patients also receive concurrent gefitinib PO QD for 6-7 weeks.
Patients then undergo surgery. After surgery, patients receive gefitinib PO QD for up to 12
months.
After completion of study treatment, patients are followed up for up to 5 years.
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