A Phase III Trial of Erlotinib and Radiotherapy in Patients With Stage III Cutaneous Squamous Cell Carcinomas
This is a single-institution, open-label, non-randomized phase II trial of erlotinib
administered concomitantly with radiation therapy following surgical resection of gross
disease. A total of 45 patients with previously unirradiated, high-risk cutaneous SCC
requiring post-operative radiotherapy will be enrolled to assess the primary endpoints of
time to recurrence and disease free survival. Pretreatment biopsies will be required to
confirm the histological diagnosis of SCC. Four to six weeks after surgical resection,
patients will begin erlotinib (150 mg po qd) beginning the first day of radiotherapy.
Patients will receive 5040 cGy beginning on day 1 of therapy in standard fractionations.
Patients will be followed to evaluate for toxicity based on NCI common toxicity criteria
(v3.0). Patients will be followed on protocol for a minimum of 2 years with regularly
scheduled CT scans, clinical evaluations, and laboratory work. Patients with residual or
recurrent cancer will be taken off protocol for salvage therapy.
As a secondary objective, molecular response of tumors to erlotinib monotherapy will be
determined. When possible, participants will be enrolled and treated for 14 days with
erlotinib prior to surgical resection. The pretreatment biopsy specimen (control) will then
be compared to tissue acquired during the surgical resection after 14 days of erlotinib
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assess toxicities associated with combined radiotherapy and erlotinib treatments.
Eben Rosenthal, M.D.
University of Alabama at Birmingham
United States: Institutional Review Board
|University of Alabama at Birmingham Medical Center||Birmingham, Alabama 35233|