Clinical trial NCT00880386: Losartan in Treating Pulmonary Fibrosis in Patients With Stage I, II, or III Non-Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dyspnea
Lung Cancer
Pulmonary Complications
Radiation Fibrosis
Keywords: 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
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-04-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Change in carbon monoxide diffusing capacity (DLCO) at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Feasibility of losartan potassium as treatment for radiation-induced pulmonary fibrosis
timeFrame: 6 months
measure: Pulmonary function measurements of FEV1 and FVC and dyspnea score at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University of South Florida
name: Marisa Couluris, DO
role: PRINCIPAL_INVESTIGATOR
References: