Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Budesonide in Treating Patients With Lung Nodules at High Risk of Developing Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Biomarker/Laboratory analysis, Prevention	Closed	50 and over	NCI	MDA-05-5-01 MDA-S262/505, MDA-2005-0953, EUDRACT-2005-004614-32, MDA05-5-01, NCT00321893

Objectives

Primary

1. 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

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

Entry 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)

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

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

Expected Enrollment

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

Outcomes

Shrinkage of lung nodules in a person-specific analysis by RECIST criteria

Lesion-specific analysis by measuring average change in size of the target lesions or in the number of lesions
Bi-dimensional measurement of lesions compared by RECIST and WHO criteria
Three-dimensional measurement of lung nodules compared by RECIST and WHO criteria
Tumoral markers in sputum and plasma compared among the treated group and control group before and after treatment
Modulation of ultrasensitive C-reactive protein (CRP)
Treatment-related toxicity as measured by NCI CTCAE v3.0
Safety as measured by NCI CTCAE v3.0
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
Comparison between low dose CT scan and pulmonary function test (PFT) evaluation of emphysema

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.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Giulia Veronesi, MD, Protocol chair		Ph: 39-02-5748-9666 Email: giulia.veronesi@ieo.it
Scott Lippman, MD, FACP, Protocol co-chair		Ph: 713-745-3672; 800-392-1611

Registry Information
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
Trial Start Date		2006-04-18
Registered in ClinicalTrials.gov		NCT00321893
Date Submitted to PDQ		2006-02-23
Information Last Verified		2007-06-28
NCI Grant/Contract Number		CN35159, CA16672

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