A Trial of Erlotinib + Radiotherapy for Cutaneous Squamous Cell Carcinoma
Condition: Cancer
MeSH terms: Carcinoma; Carcinoma, Squamous Cell
Intervention: Erlotinib
Intervention description: Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: Phase II; Erlotinib; Radiotherapy; Squamous Cell Carcinomas; Cutaneous; Stage III

Summary:

      This is a phase II study designed to study the effectiveness of combined radiotherapy and
      erlotinib in the postoperative setting for patients with cutaneous SCC that are at high risk
      for recurrence. Participants enrolled in the study will be evaluated by a head and neck
      surgeon, and a radiation oncologist. Whenever possible, a preoperative biopsy will be
      performed after participant enrollment in the study for histological confirmation and for
      molecular correlates. Participants enrolled prior to surgical resection will begin erlotinib
      at 150 mg by mouth (PO) every day (QD) (14 tablets) to be taken 14 days prior to surgical
      resection. Following planned surgical resection, the participant will begin Erlotinib therapy
      and radiotherapy at the same time and within 4-8 weeks of the surgical resection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven primary or recurrent squamous cell carcinoma arising from the
             lip or skin of the face, ear, scalp or neck.

          -  Participants must meet one of the four criteria:

          -  1. T4 cutaneous SCC as determined by physical exam, imaging studies, prior resections
             or biopsy. T4 disease is defined as tumor that invades deep extradermal structures
             such as cartilage, skeletal muscle (e.g., muscles of facial expression), parotid gland
             or bone.Patients with a T2 or greater squamous cell carcinoma of the lower lip who
             will require post operative radiation will be allowed.

          -  2. Histologically proven regional lymph node involvement (N1 disease). Fine needle
             aspiration or biopsy can be used to demonstrate the presence of lymphatic spread.

          -  3. Histologically proven parotid gland metastasis. Fine needle aspiration or biopsy
             can be used to demonstrate the presence of regional spread. Includes delayed regional
             metastasis; primary scalp or other skin lesion treated within 36 months that would
             drain into the involved parotid.

          -  4. Patients who following surgical resection of the primary are found to have
             histologically positive lymph nodes (N1). Includes delayed regional metastasis;
             primary lip or cutaneous lesion treated within 36 months that would drain into the
             involved nodal basin.

          -  Age > 19 years

          -  Tumors must be considered surgically resectable.(Patients may be enrolled after
             surgery is completed as long as Erlotinib therapy and concurrent radiation is started
             within 8 weeks of surgical resection.)

          -  Required laboratory data obtained prior to beginning treatment: WBC > 1,500/ml;
             Platelets > 90,000; serum creatinine ≤ 2.0 mg/dl

          -  The patient may have had a prior non-cutaneous malignancy, but must be two years from
             treatment.

          -  Performance status of ≤ 2 (ECOG scale) and life expectancy ≥ 12 months.

          -  The patients must agree to use effective contraception if there is the potential for
             procreativity. Contraception must be conducted for at least 3 months following the
             study.

          -  Patients must sign informed consent

        Exclusion Criteria:

          -  The patient has received prior radiation therapy to the head and neck.

          -  The patient is pregnant or lactating

          -  Patients with a prior history of head and neck mucosal cancers.

          -  Psychological condition that renders the patient unable to understand the informed
             consent.