Phase II Trial of Erlotinib, Prior to Surgery or Radiation in Patients With Squamous Cell Cancers (SCC) of the Skin
Condition: Skin Cancer
MeSH terms: Neoplasms, Squamous Cell; Carcinoma, Squamous Cell
Intervention: Erlotinib
Intervention description: 150 mg daily by mouth before surgery and/or radiation therapy (Induction Treatment); and after surgery and/or radiation erlotinib for up to 1 year (Maintenance Phase).
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Erlotinib; Erlotinib Hydrochloride; OSI-774; Tarceva; Squamous cell carcinoma of the skin; Aggressive cutaneous squamous cell carcinoma; CSCC; Local surgery; Radiation therapy; Epidermal growth factor receptor; EGFR; Small Molecule Tyrosine Kinase Inhibitor

Summary:

      The goal of this clinical research study is to learn if Tarceva ® (erlotinib) when taken
      before and after radiation and/or surgery can help to control aggressive cutaneous squamous
      cell carcinoma. The safety of the drug will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Within 12 weeks prior to study entry, patient must have histologically or
             cytologically confirmed cutaneous squamous cell carcinoma (CSCC) that is either
             locally advanced or recurrent, and no evidence of distant metastases. If the biopsy
             was collected outside of MD Anderson Cancer Center (MDACC), the MDACC Pathology
             Department must assess and confirm the SCC diagnosis.

          2. Patient is eligible with previous surgical intervention if they have residual or
             recurrent disease, it is greater than 6 weeks since surgery and they have fully
             recovered from the surgery.

          3. Patient must have measurable disease.

          4. Tumor must be at least 2 centimeters in size as measured by the treating physician(s)
             or PI, or have histological or cytological verification of muscle, bone, lymph node
             metastasis, or perineural involvement,.

          5. Surgical resection or radiation must be planned as part of the treatment strategy for
             the CSCC.

          6. At least 18 years of age.

          7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

          8. Must have adequate organ and marrow function as follows:(a) leukocytes >/= 3,000/mm^3
             (b) absolute neutrophil count >/= 1,500/mm^3 (c) platelets >/= 75,000/mm^3 (d)
             hemoglobin >/= 8g/dL (e) total bilirubin </= 2 X institutional upper limit of normal
             (ULN) (f) AST(SGOT)/ALT(SGPT) </= 2.5 X ULN if alkaline phosphatase is normal, or
             alkaline phosphatase </= 4 x ULN if transaminases are normal (g) Creatinine </= 2.0 x
             ULN or creatinine clearance >/= 60 mL/min/1.73 m^2

          9. Must be able to take intact tablets by mouth, or be able to take tablets dissolved in
             water by mouth or by a percutaneous gastrostomy tube.

         10. Patients - both males and females - with reproductive potential (includes women who
             are menopausal for less than 1 year and not surgically sterilized) must practice
             effective contraceptive measures throughout the study. Birth control should continue
             for 4 weeks after discontinuation of erlotinib therapy. Women of childbearing
             potential must provide a negative pregnancy test (serum betaHCG) within within 72
             hours prior to first receiving protocol therapy.

         11. Must have 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 MDACC "Policy For Consenting Non-English Speaking
             Participants."

         12. Must be willing to receive their definitive local therapy, that is surgery and / or
             radiation therapy, at M. D. Anderson Cancer Center.

         13. Organ transplant patients are eligible as long as they do not have active signs of
             rejection and have adequate bone marrow function.

        Exclusion Criteria:

          1. Women who are pregnant, breastfeeding, or have child-bearing potential & are
             unwilling/unable to use an acceptable method of contraception for the entire study
             period & for at least 4 weeks after cessation of the study drugs. If the pregnancy
             test is positive, the patient must not receive erlotinib, & must not be enrolled on
             the study. Erlotinib is a signal transduction inhibitor agent w/ the potential for
             teratogenic or abortifacient effects.

          2. -continued from Exclusion #1- If the pregnancy test is positive, the patient must not
             receive erlotinib, and must not be enrolled on the study. Erlotinib 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 erlotinib, breastfeeding should be
             discontinued if the mother is treated with erlotinib.

          3. Patient with distant metastatic disease.

          4. Patient who has had previous radiotherapy to the site of the skin cancer being treated
             on this protocol.

          5. Patient currently receiving any other anticancer or investigational agents at time of
             study enrollment.

          6. Patient has received prior EGFR inhibitor therapy.

          7. Patient with a history of an invasive malignancy (other than the one treated in this
             study) or lymphoproliferative disorder within the past 5 years. Patients with a
             history of adequately treated non-melanoma skin cancer, ductal carcinoma in situ of
             the breast or carcinoma in situ of the cervix are allowed.

          8. Patient with history of allergic reactions attributed to compounds of similar chemical
             or biologic composition to erlotinib.

          9. Patient is unwilling or unable to discontinue prohibited concomitant therapies.

         10. In the opinion of the investigator, patient with any condition that is unstable or
             could jeopardize the safety of the patient or could limit compliance with the study's
             requirements. These include, but are not limited to, ongoing or active infection
             requiring parenteral antibiotics at time of study registration, psychiatric illness
             that would limit compliance with study requirements or symptomatic congestive heart
             failure (NYHA class II or greater), unstable angina pectoris or cardiac arrhythmia
             requiring maintenance medication.

         11. Patient with a history of pulmonary fibrosis (other than in a radiated field) or
             chronic liver disease.

         12. Patients with active gastrointestinal disease or a disorder that alters
             gastrointestinal motility or absorption; for example, a significant surgical resection
             of the stomach or small bowel, uncontrolled inflammatory bowel disease or uncontrolled
             chronic diarrhea.