Erlotinib in Treating Patients With Recurrent or Metastatic Skin Squamous Cell Carcinoma
Condition: Metastatic Skin Squamous Cell Carcinoma; Recurrent Skin Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Recurrence
Intervention: Erlotinib
Intervention description: Given PO
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well erlotinib works in treating participants with skin
      squamous cell carcinoma that has spread to other places in the body or has come back. Drugs
      used in chemotherapy, such as erlotinib, work in different ways to stop the growth of tumor
      cells, either by killing the cells, by stopping them from dividing, or by stopping them from
      spreading.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have histologically or cytologically confirmed cutaneous squamous cell carcinoma
             (CSCC) that is not amenable to curative therapy. If the biopsy was collected outside
             of MD Anderson Cancer Center (MDACC), the MDACC Pathology Department must assess and
             confirm the squamous cell carcinoma (SCC) diagnosis.

          -  Have measurable disease.

          -  Have Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

          -  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.

          -  Leukocytes >= 3,000/mm^3.

          -  Absolute neutrophil count >= 1,500/mm^3.

          -  Platelets >= 75,000/mm^3.

          -  Hemoglobin >= 8g/dL.

          -  Total bilirubin =< 2 x institutional upper limit of normal (ULN).

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x
             ULN if alkaline phosphatase is normal, or alkaline phosphatase =< 4 x ULN if
             transaminases are normal.

          -  Creatinine =< 2.0 x ULN or creatinine clearance >= 60 mL/min/1.73 m^2.

          -  Prior radiotherapy is allowed if: (a) there is measurable disease outside the
             radiation field OR (b) radiotherapy was completed more than 4 weeks ago and there is
             clearly recurrent and growing disease within the radiation field.

          -  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.

          -  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 such as barrier methods, condom or diaphragm with
             spermicide, or abstinence 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 beta human chorionic gonadotropin [HCG])
             within 72 hours prior to first receiving protocol therapy.

          -  Organ transplant patients are eligible as long as they do not have active signs of
             rejection and have adequate bone marrow function.

        Exclusion Criteria:

          -  Women who are pregnant, breastfeeding, and women and men not practicing effective
             birth control. 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.

          -  Prior estimated glomerular filtration rate (EGFR) inhibitor therapy is not allowed
             (including, but not limited to, erlotinib, gefitinib, cetuximab, panitumumab,
             vandetanib).

          -  Patients who are receiving any other anticancer or investigational agents at time of
             study enrollment. Patients may have received one other systemic therapy or
             investigational agent in the past, but a washout time period of at least 4 weeks and
             recovery of any treatment-related toxicities to < Common Terminology Criteria for
             Adverse Events version 4 (CTCAEv4) grade 2 is required.

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to erlotinib.

          -  Patients with a history of an invasive malignancy (other than the one treated in this
             study) or lymphoproliferative disorder within the past 3 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.

          -  Patients with incomplete healing from previous surgery.

          -  Patients with pulmonary fibrosis (other than in a radiated field) or active
             interstitial lung disease.

          -  Patients with active gastrointestinal disease or a disorder that alters
             gastrointestinal motility or absorption, including lack of integrity of the
             gastrointestinal tract (for example, a significant surgical resection of the stomach
             or small bowel, inflammatory bowel disease or uncontrolled chronic diarrhea.

          -  Patients with skin rash CTCAEv4 grade 2.

          -  In the opinion of the investigator, patients 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 (New York Heart Association [NYHA] class II or greater), unstable angina
             pectoris or cardiac arrhythmia requiring maintenance medication.

          -  Patient is unwilling or unable to discontinue prohibited concomitant therapies, (i.e
             St. John's wort, grapefruit juice, histamine type 2 receptor [H2] blockers/proton pump
             inhibitors, strong CYP3A4 inhibitors and inducers).