A Pilot Project to Determine the Effect of Losartan (Cozaar) on Radiation-Induced Pulmonary Fibrosis in Patients With Non-Small Cell Lung Cancer
- To evaluate the effects of losartan potassium on the disease progression in patients
with stage I-III non-small cell lung cancer and radiation-induced pulmonary fibrosis.
- To determine the feasibility of losartan potassium as a possible treatment for
radiation-induced pulmonary fibrosis.
- The evaluate the effects of losartan potassium on the degree of dyspnea, and lung
function (FEV_1 and FVC) in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral losartan potassium once daily for 6 months in the absence of disease
progression or unacceptable toxicity.
Patients undergo assessment of pulmonary function (e.g., gas movement, lung capacity, and
diffusion of gases) by spirometry and dyspnea by the Visual Analog Scale (VAS) at baseline
and at weeks 12 and 24.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Change in carbon monoxide diffusing capacity (DLCO) at 6 months
Marisa Couluris, DO
University of South Florida
United States: Food and Drug Administration