Know Cancer

or
forgot password

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


Phase 2
50 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

Number (and Size) CT-detected Lung Nodules by Participant

Outcome Description:

Lung nodules in a person-specific analysis by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.

Outcome Time Frame:

Baseline to 3 Years

Safety Issue:

No

Principal Investigator

Giulia Veronesi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

European Institute of Oncology

Authority:

United States: Institutional Review Board

Study ID:

2005-0953

NCT ID:

NCT00321893

Start Date:

January 2006

Completion Date:

September 2011

Related Keywords:

  • Lung Cancer
  • Small cell lung cancer
  • Non-small cell lung cancer
  • Budesonide
  • Entocort EC
  • Pulmicort Respules
  • Rhinocort aqua
  • Aerosol budesonide treatment
  • Smoking
  • Lung Neoplasms

Name

Location