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

This study has been withdrawn prior to enrollment.
(Study concept was not approved by NCI. Study was never activated. No enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00880386
First Posted: April 13, 2009
Last Update Posted: May 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of South Florida
  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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: 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 University of South Florida:

Primary Outcome Measures:
  • Change in carbon monoxide diffusing capacity (DLCO) at 6 months [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Feasibility of losartan potassium as treatment for radiation-induced pulmonary fibrosis [ Time Frame: 6 months ]
  • Pulmonary function measurements of FEV1 and FVC and dyspnea score at 6 months [ Time Frame: 6 months ]

Enrollment: 0
Study Start Date: March 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Losartan Group
50 mg Losartan tablet taken daily for 24 weeks
Drug: Losartan
50 mg Losartan will be taken daily by subjects for 24 weeks
Other Names:
  • Cozaar
  • losartan potassium

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00880386


Sponsors and Collaborators
University of South Florida
National Cancer Institute (NCI)
Investigators
Principal Investigator: Marisa Couluris, DO University of South Florida
  More Information

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT00880386     History of Changes
Other Study ID Numbers: SCUSF 0208
SCUSF-PILOT-0208 ( Other Identifier: SunCoast CCOP Research Base )
HLMCC-PILOT-0208 ( Other Identifier: H. Lee Moffitt Cancer Center Research Base )
First Submitted: April 10, 2009
First Posted: April 13, 2009
Last Update Posted: May 2, 2017
Last Verified: May 2017

Keywords provided by University of South Florida:
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

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