Study Stopped
Study concept was not approved by NCI. Study was never activated. No enrollment
Losartan in Treating Pulmonary Fibrosis in Patients With Stage I, II, or III Non-Small Cell Lung Cancer
A Pilot Project to Determine the Effect of Losartan (Cozaar) on Radiation-Induced Pulmonary Fibrosis in Patients With Non-Small Cell Lung Cancer
3 other identifiers
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2009
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 10, 2009
CompletedFirst Posted
Study publicly available on registry
April 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedMay 2, 2017
May 1, 2017
1.1 years
April 10, 2009
May 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in carbon monoxide diffusing capacity (DLCO) at 6 months
6 months
Secondary Outcomes (2)
Feasibility of losartan potassium as treatment for radiation-induced pulmonary fibrosis
6 months
Pulmonary function measurements of FEV1 and FVC and dyspnea score at 6 months
6 months
Study Arms (1)
Losartan Group
EXPERIMENTAL50 mg Losartan tablet taken daily for 24 weeks
Interventions
50 mg Losartan will be taken daily by subjects for 24 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of South Floridalead
- National Cancer Institute (NCI)collaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marisa Couluris, DO
University of South Florida
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2009
First Posted
April 13, 2009
Study Start
March 1, 2009
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
May 2, 2017
Record last verified: 2017-05