Losartan in Treating Pulmonary Fibrosis in Patients With Stage I, II, or III Non-Small Cell Lung Cancer

University of South Florida

Status: Withdrawn

Conditions: Radiation Fibrosis; Dyspnea; Lung Cancer; Pulmonary Complications

Treatments: Drug: Losartan

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00880386

SCUSF 0208

SCUSF-PILOT-0208 (Other Identifier)

HLMCC-PILOT-0208 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Losartan Group

Experimental group

Description:

50 mg Losartan tablet taken daily for 24 weeks

Treatment:

Drug: Losartan