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

Condition(s) targeted: Dyspnea; Lung Cancer; Pulmonary Complications; Radiation Fibrosis

Intervention: losartan potassium (Drug); questionnaire administration (Other); breath test (Procedure)

Phase: N/A

Status: Not yet recruiting

Sponsored by: H. Lee Moffitt Cancer Center and Research Institute

Official(s) and/or principal investigator(s):
Marisa Couluris, DO, Principal Investigator, Affiliation: University of South Florida

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.

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 design: Supportive Care

Primary outcome: Change in carbon monoxide diffusing capacity (DLCO) at 6 months

Secondary outcome:

Feasibility of losartan potassium as treatment for radiation-induced pulmonary fibrosis

Pulmonary function measurements of FEV1 and FVC and dyspnea score at 6 months

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

DISEASE CHARACTERISTICS:

- Diagnosis of non-small cell lung cancer

- Stage I, II, IIIA, or IIIB disease

- Diagnosis of radiation therapy-induced pulmonary fibrosis within 2 years of last

radiation treatment

- Grade I-III disease as defined by NCI CTCAE v3. 0

- Diagnosis and grading based on radiographic changes of ≥ grade 1, defined as

minimal radiographic findings (or patchy or bibasilar changes) with estimated radiographic proportions of total lung volume < 25% (if fibrotic)

PATIENT CHARACTERISTICS:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Not currently smoking or smoked within the past 6 months

- No baseline systolic blood pressure < 100 mm Hg

- No bilateral renal artery stenosis, hereditary or idiopathic angioedema, or

uncontrolled hypotension

- No history of kidney failure or liver disease

- Able to attend clinic visits

- No allergy or allergic reaction to losartan potassium or any other angiotensin II

receptor blocker

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- More than 6 months since prior and no concurrent use of another angiotensin II

receptor blocker (i. e., losartan potassium, valsartan, irbesartan, candesartan, cilexetil, eprosartan mesylate, or telmisartan)

- No history of lung transplant

- No prior pneumonectomy

- No concurrent lithium

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: May 2009
Last updated: June 9, 2009