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

Primary Purpose

Dyspnea, Lung Cancer, Pulmonary Complications

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Losartan
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dyspnea focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Losartan Group

    Arm Description

    50 mg Losartan tablet taken daily for 24 weeks

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    April 10, 2009
    Last Updated
    May 1, 2017
    Sponsor
    University of South Florida
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00880386
    Brief Title
    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

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study concept was not approved by NCI. Study was never activated. No enrollment
    Study Start Date
    March 2009 (undefined)
    Primary Completion Date
    April 2010 (Actual)
    Study Completion Date
    April 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of South Florida
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Losartan Group
    Arm Type
    Experimental
    Arm Description
    50 mg Losartan tablet taken daily for 24 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Losartan
    Other Intervention Name(s)
    Cozaar, losartan potassium
    Intervention Description
    50 mg Losartan will be taken daily by subjects for 24 weeks
    Primary Outcome Measure Information:
    Title
    Change in carbon monoxide diffusing capacity (DLCO) at 6 months
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Feasibility of losartan potassium as treatment for radiation-induced pulmonary fibrosis
    Time Frame
    6 months
    Title
    Pulmonary function measurements of FEV1 and FVC and dyspnea score at 6 months
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marisa Couluris, DO
    Organizational Affiliation
    University of South Florida
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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