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This study has been withdrawn prior to enrollment.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:
University of South Florida
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
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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:
|
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 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 May 22, 2013