Lung Cancer Clinical Trial
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
Verified date | May 2017 |
Source | University of South Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 2010 |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of South Florida | National Cancer Institute (NCI) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in carbon monoxide diffusing capacity (DLCO) at 6 months | 6 months | ||
Secondary | Feasibility of losartan potassium as treatment for radiation-induced pulmonary fibrosis | 6 months | ||
Secondary | Pulmonary function measurements of FEV1 and FVC and dyspnea score at 6 months | 6 months |
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