A Randomized, Open-Label Phase II Clinical Trial of Combination Erlotinib (Tarceva®) and Fulvestrant (Faslodex®) Versus Erlotinib (Tarceva®) Alone in Advanced Non-Small Cell Lung Cancer Patients
- Compare objective tumor response in patients stage IIIB or IV non-small cell lung
cancer treated with erlotinib hydrochloride with vs without fulvestrant.
- Correlate response rate with ER and EGF receptor expression in patients treated with
- Correlate measurement of ER-α, ER-β, EGF/HER-1 receptor and HER-2/neu receptor with
clinical response in patients treated with these regimens.
- Correlate erlotinib hydrochloride resistance with ER and HER receptor expression in
patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to performance status, gender, and participating center. Patients are randomized
to 1 of 2 treatment arms.
- Arm I: Patients receive oral erlotinib hydrochloride once daily on days 1-28. Courses
repeat every 28 days.
- Arm II: Patients receive erlotinib hydrochloride as in arm I and fulvestrant
intramuscularly on days 1, 15, and 29, and then every 28 days thereafter.
In both arms, treatment continues in the absence of disease progression or unacceptable
After completion of study treatment, patients are followed for 30 days and then every 2
months until disease progression.
PROJECTED ACCRUAL: A total of 102 patients (34 in arm I and 68 in arm II) will be accrued
for this study.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective tumor response
Edward Garon, MD
Jonsson Comprehensive Cancer Center
United States: Food and Drug Administration
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|