Phase II Trial of Second Line Erlotinib + Digoxin in Patients With Non-Small Cell Lung Cancer
Non-small cell lung cancer (NSCLC) accounts for 80% of all lung cancer cases. The majority
of NSCLC patients have advanced disease at the time of diagnosis, which usually requires
treatment beyond standard first-line chemotherapy. Until recently, patients were limited in
the number of options available for second-line treatment of NSCLC. In 2004, erlotinib was
approved by the FDA for second and third-line treatment of NSCLC. Erlotinib is a cancer
chemotherapy medication that slows the growth and spread of cancer cells in the body.
Recent research suggests that a medication called Digoxin can sensitize cancer cells to
respond better to chemotherapy. Digoxin is normally used to treat certain heart conditions
by helping the heart beat more strongly and regularly and is not approved by the FDA for the
treatment of NSCLC. Investigators hope that subject response rates to standard erlotinib
therapy will be significantly improved by the addition of Digoxin.
The purpose of this study is to determine the tumor response rate and overall survival of
patients with non-small cell lung cancer treated with a daily regimen of erlotinib (Tarceva)
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Therapeutic response, evaluated by computed tomography (CT) scans of chest & abdomen.
every 6 months until disease progression
Goetz H Kloecker, MD, MSPH
James Graham Brown Cancer Center/ University of Louisville
United States: Institutional Review Board