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This study has been withdrawn prior to enrollment.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:
Collaborator:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT00880386
First received: April 10, 2009
Last updated: May 21, 2013
Last verified: January 2013
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00880386

Sponsors and Collaborators
University of South Florida
Investigators
Principal Investigator: Marisa Couluris, DO University of South Florida
  More Information

Additional Information:
No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT00880386     History of Changes
Other Study ID Numbers: SCUSF 0208, SCUSF-PILOT-0208, HLMCC-PILOT-0208
Study First Received: April 10, 2009
Last Updated: May 21, 2013
Health Authority: United States: Food and Drug Administration

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:
Carcinoma, Non-Small-Cell Lung
Dyspnea
Fibrosis
Lung Neoplasms
Pulmonary Fibrosis
Radiation Pneumonitis
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Pathologic Processes
Lung Diseases, Interstitial
Lung Injury
Radiation Injuries
Wounds and Injuries
Losartan
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on July 29, 2014