A Pilot Project to Determine the Effect of Losartan (Cozaar) on Radiation-Induced Pulmonary Fibrosis in Patients With Non-Small Cell Lung Cancer
18 Years
N/A
Both
Dyspnea, Lung Cancer, Pulmonary Complications, Radiation Fibrosis
Trial Information
A Pilot Project to Determine the Effect of Losartan (Cozaar) on Radiation-Induced Pulmonary Fibrosis in Patients With Non-Small Cell Lung Cancer
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Inclusion Criteria
INCLUSION CRITERIA:
- At least 18 years of age or older
- Diagnosed with non-small cell lung cancer stage I, II, IIIa, or IIIb
- Diagnosis of radiation-induced pulmonary fibrosis (as defined by National Cancer
Institute's Common Terminology Criteria for Adverse Events [CTCAE] V3.0 Grade I to
Grade III) and within 2 years of the last radiation therapy treatment
EXCLUSION CRITERIA:
- Patients with a pneumonectomy
- Allergy or allergic reaction to Losartan or any other angiotensin II receptor blocker
- Use of an angiotensin II receptor blocker currently or within 6 months of study entry
which include: losartan, valsartan, irbesartan, candesartan, cilexetil, eprosartan
mesylate, and telmisartan
- Bilateral renal artery stenosis, hereditary or idiopathic angioedema, or uncontrolled
hypotension
- Patients taking lithium
- Currently smoking or smoked within 6 months of study entry
- Pregnant, intending to become pregnant or breastfeeding
- Baseline systolic blood pressure < 100 mmHg
- History of lung transplant
- History of kidney failure or liver disease
- Inability to attend clinic visits
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Change in carbon monoxide diffusing capacity (DLCO) at 6 months
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Marisa Couluris, DO
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of South Florida
Authority:
United States: Food and Drug Administration
Study ID:
SCUSF 0208
NCT ID:
NCT00880386
Start Date:
March 2009
Completion Date:
April 2010
Related Keywords:
- Dyspnea
- Lung Cancer
- Pulmonary Complications
- Radiation Fibrosis
- dyspnea
- stage I non-small cell lung cancer
- stage II non-small cell lung cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- pulmonary complications
- radiation fibrosis
- Carcinoma, Non-Small-Cell Lung
- Dyspnea
- Fibrosis
- Lung Neoplasms
- Pulmonary Fibrosis
- Radiation Pneumonitis
Name | Location |
|---|
