Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Supportive care	Approved-not yet active	18 and over	NCI	MCC-PILOT-0208 PILOT 0208, NCT00880386

Objectives

Primary

1. 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.
2. To determine the feasibility of losartan potassium as a possible treatment for radiation-induced pulmonary fibrosis.

Secondary

1. The evaluate the effects of losartan potassium on the degree of dyspnea, and lung function (FEV₁ and FVC) in these patients.

Entry 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)

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

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

Expected Enrollment

Outcomes

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

Feasibility of losartan potassium as treatment for radiation-induced pulmonary fibrosis
Pulmonary function measurements of FEV1 and FVC and dyspnea score at 6 months

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.

Trial Contact Information

Trial Lead Organizations

H. Lee Moffitt Cancer Center CCOP Research Base

Marisa Couluris, DO, Principal investigator		Ph: 813-396-9547

Registry Information
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
Trial Start Date		2009-05-01 (estimated)
Trial Completion Date		2010-11-01 (estimated)
Registered in ClinicalTrials.gov		NCT00880386
Date Submitted to PDQ		2009-03-11
Information Last Verified		2009-06-07
NCI Grant/Contract Number		CA76292

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