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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Oral Gefitinib induction therapy given daily for 2 months at 250 mg/day, once a day for 30 days (1 cycle = 30 days) with at least 2 cycles of treatment (60 days) given. After 2 months evaluate for clinical response (15 days) and resectability (60 days). If after 15 days with no tumor response, daily dose doubled (500 mg), and discontinuation if tumor progression.
Undergo radiation therapy treatments once a day Monday through Friday for about 7 weeks. Each treatment takes about 15 minutes.
Undergo surgery
M D Anderson Cancer Center
Houston, Texas, United States
Early Progression Rate
Number of participants out of total participants with progression following two 30 day courses of Gefitinib. Tumor response evaluated by Response Evaluation Criteria in Solid Tumors by physical exam, computed tomography (CT) or Magnetic Resonance Imaging (MRI). Progressive disease defined as determined as response to Gefitinib induction therapy: Progression: 25% increase in sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Participants restaged on days 15 and 60 of treatment.
Time frame: Baseline to 60 days, up to 2 courses of induction therapy
Number of Participants With Response Rate During Induction, Dose Escalation, and Concomitant With Radiation.
Completion Induction phase, participants are evaluated for clinical response and resectability. Resectable participants who had achieved at least stable disease and received surgery followed by radiation. Unresectable participants who had achieved at least stable disease received concomitant radiation/Gefitinib.
Time frame: Up to 100 days
Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3)
Severity and timing of toxicities evaluated according to NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3. Occurrences of late (post-radiation) toxicities that are radiation-related monitored and included.
Time frame: Up to 5 years
Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3)
Severity and timing of toxicities evaluated according to NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3. Occurrences of late (post-radiation) toxicities that are radiation-related monitored and included.
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Correlative studies
Time frame: Up to 5 years
Clinical Response According to Response Evaluation Criteria In Solid Tumors (RECIST)
Number participants with response defined by RECIST: Complete Response (CR): Disappearance all disease; No new lesions/non-evaluable disease; Responders on none/only maintenance doses of corticosteroids. Partial Response (PR): \>/= 50% decrease under baseline in sum products perpendicular diameters of measurable lesions; No progression evaluable disease/new lesions; Responders on same/decreasing doses dexamethasone \& stable/improved neurological exams. Stable/No Response (SD): Not qualify for CR, PR, or progression; requires minimum 12 weeks duration; Responders on same/decreasing doses dexamethasone \& stable/improved neurological exams. Progression (PD): 25% increase in sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease), OR clear worsening any evaluable disease, OR appearance any new lesion/site, OR failure to return due to death/deteriorating condition. All measurable/evaluable sites assessed using same baseline techniques.
Time frame: Up to 5 years
Frequency and Timing of Local and Distant Failures
Time frame: From study entry to first documented local recurrence or last patient contact, assessed up to 5 years