Gefitinib in Treating Patients Who Are Undergoing Surgery and/or Radiation Therapy for Locally Advanced or Recurrent Squamous Cell Skin Cancer
Condition: Recurrent Skin Cancer; Squamous Cell Carcinoma of the Skin
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Skin Neoplasms; Recurrence
Intervention: Gefitinib; Radiotherapy; Conventional surgery; laboratory biomarker analysis
Intervention description: 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; Correlative studies
Intervention MeSH terms: Gefitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: squamous cell carcinoma of the skin; recurrent skin cancer; non-melanomatous skin cancer; Radiation; ZD1839; Iressa; Gefitinib

Summary:

      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
    

Eligibility criteria:

        Inclusion Criteria:

          -  Within 12 weeks (+/- 2 weeks) prior to study entry, patients must have histologically
             or cytologically confirmed squamous cell carcinoma (SCC) of skin that is either
             locally advanced or recurrent with measurable disease; if the biopsy was collected
             outside of MDACC, the MDACC Pathology Department must assess and confirm the SCC
             diagnosis

          -  Patients may have previous surgical intervention with residual or recurrent disease

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

          -  Leukocytes >= 3,000/mm^3

          -  Absolute neutrophil count >= 1,500/mm^3

          -  Platelets >= 100,000/mm*3

          -  Total bilirubin within normal institutional limits

          -  aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) =<
             2.5 * institutional upper limit of normal

          -  Creatinine within normal institutional limits OR; creatinine clearance >= 60
             mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

          -  Tumors must be at least 2 cms in size or have histological or cytological verification
             of muscle, bone, lymph node metastasis, or perineural involvement, as measured by the
             treating physician(s) or National principal investigator (PI)

          -  Negative serum pregnancy test for women of child-bearing potential (performed within
             14 days, +/- 1 day, prior to start of treatment); women of child-bearing potential and
             men must agree to use adequate contraception prior to study entry and for the duration
             of study participation; should a woman become pregnant or suspect she is pregnant
             while participating in the study, she should inform her treating physician(s)
             immediately

          -  Ability to understand and the willingness to sign a written Informed Consent Document
             (ICD); in the event that non-English speaking participants are eligible for this
             study, a short form (if applicable) or an ICD in their language, will be utilized and
             completed in accordance with the MD Anderson's "Policy For Consenting Non-English
             Speaking Participants"

        Exclusion Criteria:

          -  Patients who have previous radiotherapy to the proposed site of skin cancer

          -  Patients with active cancers other than skin

          -  Patients currently receiving any other investigational agents at time of study
             enrollment; patients may have received investigational agents in the past; no washout
             time period is required

          -  Patients with a history of brain metastases must be excluded from this clinical study
             because of their poor prognosis and because they often develop progressive
             neurological dysfunction that would confound the evaluation of neurological and other
             adverse events

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to ZD1839

          -  Age less than 18 years

          -  Presence of uncontrolled intercurrent illness (co-morbid conditions) that would limit
             compliance with study requirements including , but not limited to, ongoing or active
             infection requiring parenteral antibiotics at time of study registration, symptomatic
             congestive heart failure (NYHA class II or greater), unstable angina pectoris or
             cardiac arrhythmia requiring maintenance medication

          -  Pregnant women are excluded from this study because ZD1839 is a signal transduction
             inhibitor agent with the potential for teratogenic or abortifacient effects; there is
             an unknown but potential risk for adverse events in nursing infants secondary to
             treatment of the mother with ZD1839, breastfeeding should be discontinued if the
             mother is treated with ZD1839

          -  Patients with known immune deficiency are at an increased risk when treated with
             marrow-suppressive therapy, HIV-positive patients receiving combination
             anti-retroviral therapy are excluded due to the possible pharmacokinetic interactions
             with ZD1839; appropriate studies will be undertaken in patients receiving combination
             anti-retroviral therapy when indicated

          -  CYP3A4 inducing agents; patients receiving the following CYP3A4 inducing agents will
             be excluded; these include: carbamazepine, ethosuximide, griseofulvin, modafinil,
             nafcillin, oxcarbazepine, Phenobarbital, phenylbutazone, phenytoin, rifampin,
             rifabutin, St. John's Wort, and sulfinpyrazone

          -  Patients with distant metastatic disease as determined by diagnostic imaging (i.e.,
             chest x-rays) and/or hematologic assessments (i.e., liver enzymes)