Losartan in Treating Pulmonary Fibrosis in Patients With Stage I, II, or III Non-Small Cell Lung Cancer
RATIONALE: Losartan potassium may be effective in treating pulmonary fibrosis caused by radiation therapy in patients with non-small cell lung cancer.
PURPOSE: This clinical trial is studying losartan to see how well it works in treating pulmonary fibrosis caused by radiation therapy in patients with stage I, stage II, or stage III non-small cell lung cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Pilot Project to Determine the Effect of Losartan (Cozaar) on Radiation-Induced Pulmonary Fibrosis in Patients With Non-Small Cell Lung Cancer|
- Change in carbon monoxide diffusing capacity (DLCO) at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Feasibility of losartan potassium as treatment for radiation-induced pulmonary fibrosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Pulmonary function measurements of FEV1 and FVC and dyspnea score at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Experimental: Losartan Group
50 mg Losartan tablet taken daily for 24 weeks
50 mg Losartan will be taken daily by subjects for 24 weeks
- 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.
|Principal Investigator:||Marisa Couluris, DO||University of South Florida|