Budesonide in Treating Patients With Lung Nodules at High Risk of Developing Lung Cancer - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00321893

Purpose

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of budesonide may keep lung cancer from forming in patients with lung nodules.

PURPOSE: This randomized phase II trial is studying how well inhalation budesonide works in treating patients with lung nodules who are at high risk of lung cancer.

Condition	Intervention	Phase
Lung Cancer	Drug: budesonide Other: laboratory biomarker analysis	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control
Official Title:	Randomized Phase II Trial of Budesonide Turbuhaler® 800 Micrograms/Twice Daily Versus Placebo in High-Risk Population With Undetermined Lung Nodules Detected at Screening Low Dose CT Scan

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Cancer Lung Cancer Nuclear Scans

Drug Information available for: Budesonide

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Shrinkage of lung nodules in a person-specific analysis by RECIST criteria [ Designated as safety issue: No ]

Secondary Outcome Measures:

Lesion-specific analysis by measuring average change in size of the target lesions or in the number of lesions [ Designated as safety issue: No ]
Bi-dimensional measurement of lesions compared by RECIST and WHO criteria [ Designated as safety issue: No ]
Three-dimensional measurement of lung nodules compared by RECIST and WHO criteria [ Designated as safety issue: No ]
Tumoral markers in sputum and plasma compared among the treated group and control group before and after treatment [ Designated as safety issue: No ]
Modulation of ultrasensitive C-reactive protein (CRP) [ Designated as safety issue: No ]
Treatment-related toxicity as measured by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
Safety as measured by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
Effect of the treatment on chronic obstructive pulmonary disease (COPD) as measured by FEV1, FEF 25/75, forced vital capacity, DLCO, and the Medical Research Council questionnaire before and after treatment [ Designated as safety issue: No ]
Comparison between low dose CT scan and pulmonary function test (PFT) evaluation of emphysema [ Designated as safety issue: No ]

Estimated Enrollment:	202
Study Start Date:	April 2006

Detailed Description:

OBJECTIVES:

Primary

Evaluate the effect, in terms of size and number reduction of CT scan-detected undetermined lung nodules, in asymptomatic subjects with lung nodules at high-risk for developing lung cancer treated with inhaled budesonide vs placebo.

Secondary

Compare average modification of nodule size and nodule number due to inhaled budesonide versus placebo.
Correlate the modulation of biological markers of lung cancer in serum and sputum after treatment with the modification of lung nodules sizes.
Determine treatment toxicity, side effects, and safety of inhaled budesonide.
Evaluate the role of CT scans in estimating the grade of respiratory impairment and emphysema.
Determine the effect of inhaled budesonide on respiratory function before and after treatment.

OUTLINE: This is a randomized, double-blind, placebo controlled study.

Participants are stratified according to gender, smoking habit (current vs former smoker), and nodule characteristics (solid vs semisolid or non-solid).

Participants are randomized into 1 of 2 treatment arms.

Arm I: Subjects receive inhaled budesonide twice daily for 1 year in the absence of unacceptable toxicity.
Arm II: Subjects receive inhaled placebo twice daily for 1 year in the absence of unacceptable toxicity.

Participants undergo blood and sputum collection periodically during study for biomarker and correlative studies.

After completion of study therapy, subjects are followed at 1 month and continue CT scan screening.

PROJECTED ACCRUAL: A total of 202 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Current smokers or former smokers that have stopped within the last 15 years
- Smoking history ≥ 20 pack/years
Persistence of lung nodules detected at low-dose CT scan for a second year (within the COSMOS screening program) with one of the following characteristics:
- Longest diameter between 4 and 5 mm
  - Nodules may be both stable or grown from the previous year
- Longest diameter between 5.1 mm and 8 mm
  - Nodules may be both stable or grown from the previous year (if grown, doubling time should be more than 1 year)
- Longest diameter > 8 mm
  - Nodule should have grown with a doubling time between 1 and 5 years
No more than 6 lung nodules and no suspicion of chronic granulomatous disease
No lung nodules with clearly benign morphological features on CT scan (i.e., homogenous calcification or solid nodules with regular and round or polygonal margins and distance from the pleura ≤ 1cm)

PATIENT CHARACTERISTICS:

ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
WBC > 3,000/mm³
Absolute neutrophil count > 1,500/mm³
Platelet count > 100,000/mm³
Bilirubin < 1.5 times upper limit of normal (ULN)
AST/ALT < 1.5 times ULN
Creatinine < 1.5 times ULN
Not pregnant or nursing
Fertile participants must use effective contraception
Negative pregnancy test
No HIV or other immunodeficiencies
No other malignant disease within the last 5 years, except cervical carcinoma in situ or nonmelanoma skin cancer
No contraindication to the use of inhaled corticosteroids
No history of allergy to compounds of similar chemical or biological composition to corticosteroids
No uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Serious cardiac arrhythmia
- Lung tuberculosis or other infection of the airways
- Psychiatric illness or social situations that would limit study compliance

PRIOR CONCURRENT THERAPY:

At least 3 months since other prior investigational agents
No prior or concurrent regular use, defined as a total of 3 months cumulative use within the last 12 months, of oral or inhaled corticosteroids

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321893

Locations

Italy
European Institute of Oncology
Milan, Italy, 20141

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:	Giulia Veronesi, MD	European Institute of Oncology
Investigator:	Scott M. Lippman, MD, FACP	M.D. Anderson Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000470861, MDA-05-5-01, MDA-S262/505, MDA-2005-0953, EUDRACT-2005-004614-32
Study First Received:	May 2, 2006
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00321893 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

small cell lung cancer
non-small cell lung cancer

Study placed in the following topic categories:

Anti-Inflammatory Agents
Thoracic Neoplasms
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Anti-Asthmatic Agents
Glucocorticoids
Hormones

Carcinoma, Small Cell
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Peripheral Nervous System Agents
Carcinoma, Non-Small-Cell Lung
Bronchodilator Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Thoracic Neoplasms
Respiratory System Agents
Respiratory Tract Neoplasms
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Anti-Asthmatic Agents
Hormones
Glucocorticoids

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Autonomic Agents
Therapeutic Uses
Lung Diseases
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on July 02, 2009