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Losartan in Treating Pulmonary Fibrosis Caused by Radiation Therapy in Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
This study is not yet open for participant recruitment.
Verified by National Cancer Institute (NCI), June 2009
First Received: April 10, 2009   Last Updated: June 9, 2009   History of Changes
Sponsors and Collaborators: H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00880386
  Purpose

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.


Condition Intervention
Dyspnea
Lung Cancer
Pulmonary Complications
Radiation Fibrosis
Drug: losartan potassium
Other: questionnaire administration
Procedure: breath test

Study Type: Interventional
Study Design: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Change in carbon monoxide diffusing capacity (DLCO) at 6 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Feasibility of losartan potassium as treatment for radiation-induced pulmonary fibrosis [ Designated as safety issue: No ]
  • Pulmonary function measurements of FEV1 and FVC and dyspnea score at 6 months [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: May 2009
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00880386

Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Principal Investigator: Marisa Couluris, DO University of South Florida
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center CCOP Research Base ( Viki Huegel )
Study ID Numbers: CDR0000637808, MCC-PILOT-0208
Study First Received: April 10, 2009
Last Updated: June 9, 2009
ClinicalTrials.gov Identifier: NCT00880386     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Thoracic Neoplasms
Fibrosis
Disorders of Environmental Origin
Pulmonary Fibrosis
Signs and Symptoms
Respiratory Tract Diseases
Lung Neoplasms
Signs and Symptoms, Respiratory
Anti-Arrhythmia Agents
Dyspnea
Lung Diseases, Interstitial
Losartan
Respiration Disorders
Wounds and Injuries
Cardiovascular Agents
Angiotensin II
Antihypertensive Agents
Carcinoma
Angiotensin II Type 1 Receptor Blockers
Lung Diseases
Non-small Cell Lung Cancer
Radiation Pneumonitis
Carcinoma, Non-Small-Cell Lung
Pneumonia
Radiation Injuries
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Fibrosis
Disorders of Environmental Origin
Pulmonary Fibrosis
Signs and Symptoms
Neoplasms by Site
Pathologic Processes
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Signs and Symptoms, Respiratory
Anti-Arrhythmia Agents
Dyspnea
Respiratory Tract Neoplasms
Lung Diseases, Interstitial
Losartan
Neoplasms by Histologic Type
Respiration Disorders
Wounds and Injuries
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Carcinoma
Angiotensin II Type 1 Receptor Blockers
Neoplasms
Lung Diseases
Radiation Pneumonitis
Carcinoma, Non-Small-Cell Lung
Radiation Injuries

ClinicalTrials.gov processed this record on September 04, 2009