A Phase II Clinical Study of Erlotinib (Tarceva) and Bexarotene (Targretin) Oral Capsules in Patients With Advanced Non-small Cell Lung Cancer
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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Beginning of enrollment to accrual of last subject/ data analysis
Konstantin H Dragnev, MD
Norris Cotton Cancer Center
United States: Food and Drug Administration
|Mount Sinai School of Medicine||New York, New York 10029|
|Norris Cotton Cancer Center||Lebanon, New Hampshire 03756|