Study of Tarceva and Targretin Oral Capsules in Patients With Advanced Lung Cancer

• To evaluate the objective radiographic response rates to daily oral bexarotene in combination with oral erlotinib to patients with advanced non-small cell lung cancer. [ Time Frame: Beginning of enrollment to accrual of last subject/ data analysis ] [ Designated as safety issue: No ]
  

• To correlate early PET responses with objective radiographic responses. [ Time Frame: Enrollment of first subject to accrual of last subject. ] [ Designated as safety issue: No ]
  
• To evaluate the progression-free survival and overall survival of patients with advanced NSCLC treated with bexarotene in combination with erlotinib. [ Time Frame: enrollment of first subject to analysis of data. ] [ Designated as safety issue: No ]
  
• To prospectively evaluate EGFR mutation in tumor biopsies and correlate their presence with objective radiographic responses. [ Time Frame: enrollment of first subject to analysis of the data. ] [ Designated as safety issue: No ]
  

This is a single institution open label phase II trial. Consecutive, eligible patients presenting with the diagnosis of advanced NSCLC are to be enrolled in this study. All eligible patients will receive continuous daily oral erlotinib 150 mg (Tarceva™) with daily bexarotene oral capsules 400 mg/m2 (Targretin®). The two agents will be taken at the same time. We anticipate the maximum accrual of 40 patients to this trial.

Patients will be evaluated by history, physical examination, and laboratory assessment every 4 weeks. Radiographic disease assessments by chest radiograph will be obtained every 4 weeks and computer tomography every 8 weeks or longer if clinically indicated. Whole body PET scan will be obtained at 10 days and 8 weeks. All radiographic studies will be sent to Medical Metrix Solutions (MMS) for an independent radiographic review of tumor response.