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

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00880386
• Other study ID #: SCUSF 0208
• Secondary ID: SCUSF-PILOT-0208
• Status: Withdrawn
• Phase: N/A
• First received: April 10, 2009
• Last updated: May 1, 2017
• Start date: March 2009
• Est. completion date: April 2010

Study information

• Verified date: May 2017
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Dyspnea
• Fibrosis
• Lung Cancer
• Lung Neoplasms
• Pulmonary Complications
• Pulmonary Fibrosis
• Radiation Fibrosis
• Radiation Pneumonitis

Intervention

Drug:
• Losartan
50 mg Losartan will be taken daily by subjects for 24 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	National Cancer Institute (NCI)

Outcome

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