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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00321893
First received: May 2, 2006
Last updated: November 4, 2011
Last verified: November 2011

May 2, 2006
November 4, 2011
January 2006
September 2011   (final data collection date for primary outcome measure)
  • Number (and Size) CT-detected Lung Nodules by Participant [ Time Frame: Baseline to 3 Years ] [ Designated as safety issue: No ]
    Lung nodules in a person-specific analysis by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
  • Participant Response [ Time Frame: Baseline up to 3 Years ] [ Designated as safety issue: No ]
    Number of participants with response according to RECIST criteria. For single nodules > 5 mm, clinical meaningful shrinkage of 30% or > of longest diameter (LD) considered treatment success after 1 year of treatment. For single nodules with LD <5 mm, complete disappearance considered treatment success. In case of multiple lesions success of treatment is when complete response (CR) or partial response (PR) occurs according to RECIST criteria.
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Complete list of historical versions of study NCT00321893 on ClinicalTrials.gov Archive Site
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Budesonide in Treating Patients With Lung Nodules at High Risk of Developing Lung Cancer
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

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.

OBJECTIVES:

Primary

  • Evaluate the effect, in terms of size and number reduction of computed tomography (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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Lung Cancer
  • Drug: Budesonide
    Inhaled Budesonide 800 micrograms twice daily for one year.
    Other Names:
    • Entocort EC
    • Pulmincort Respules
    • Rhinocort aqua
  • Other: Placebo
    Inhaled placebo twice daily for one year.
  • Experimental: Arm I: Budesonide
    Inhaled Budesonide twice daily for 1 year
    Intervention: Drug: Budesonide
  • Placebo Comparator: Arm II: Placebo
    Inhaled placebo twice daily for 1 year
    Intervention: Other: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
225
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Current smokers or former smokers that have stopped within the last 15 years
  2. Smoking history > 20 pack/years
  3. Age > 50 years
  4. Persistent lung nodules detected at Low dose computed tomography (LDCT) scan from previous year with 1 of the following:- longest diameter between 4&5 mm. Nodules may be stable or grown from the previous year (< 5 mm does not require additional diagnostic follow-up); longest diameter between 5.1 & 8 mm. Nodules may be stable or grown from the previous year. If grown, doubling time should be >1 year; longest diameter > 8 mm with negative PET scan, negative CT enhancement. Nodule should have grown with a doubling time between 1& 5 years; -longest diameter >8mm, non solid or partially solid nodules, stable or grown with doubling time between 1&5 years
  5. Eastern Cooperative Oncology Group (ECOG) performance status < 1 (Karnofsky >60%)
  6. Participants must have normal organ and marrow function as defined below: Leukocytes >3,000/mL, absolute neutrophil count greater than 1,500/mL, platelets greater than 100,000/mL, total bilirubin lower than 1.5 * upper normal institutional limits, aspartate aminotransferase (AST or SGOT)/alanine aminotransferase (ALT or SGPT) lower than 1.5 * upper normal institutional limits, creatinine lower than 1.5 * upper normal institutional limits
  7. Females must be postmenopausal (ie, at least 1 year passed after the last menstruation), surgically sterile, or using acceptable contraceptive measures as judged by the Investigator. (A fertile woman is defined as being of child-bearing potential, from first menstruation to 1 year after last menstruation.). Negative serum beta-HCG for women of childbearing potential will be required at baseline. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
  8. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  1. More than 6 lung nodules (suspect of chronic granulomatous disease)
  2. Lung nodules with clearly benign morphological features at CT scan (i.e, homogenous calcification, solid nodules with regular and round or polygonal margins and distance from the pleura <1cm)
  3. Subjects currently suffering from malignant disease or having had malignant disease within the last 5 years except for cervical carcinoma in situ and non melanoma skin cancer
  4. Regular/chronic use of oral or inhaled corticosteroids; regular use being defined as a total of 3 months cumulative use in the last 12 months
  5. Use of any other investigational agents at time of enrollment in the study during the three months preceding study enrollment
  6. History of allergic reactions attributed to compounds of similar chemical or biologic composition to corticosteroid
  7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Any other factor that at the investigator's discretion contraindicates the use of inhaled corticosteroids
  8. Pregnant or lactating females, or females planning to become pregnant during the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately. If needed, a pregnancy test will be performed on serum during baseline lab test
  9. HIV-positive or other patients with immunodeficiencies should be excluded because of the risk of infections
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00321893
2005-0953, MDA-05-5-01, MDA-S262/505, MDA-2005-0953, EUDRACT-2005-004614-32, CDR0000470861
Yes
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Giulia Veronesi, MD European Institute of Oncology
Study Chair: Scott M. Lippman, MD, FACP M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP