Phase 2 N=61 Randomized Double-blind Prevention

Sulindac in Preventing Lung Cancer in Current or Former Smokers With Bronchial Dysplasia

Precancerous Condition · Stage I Non-small Cell Lung Cancer · Tobacco Use Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00368927 ↗

Enrolled (actual)

Serious AEs

3.3%

Results posted

Jan 2014

Primary outcome: Primary: Percentage of Participants With Response Determined by Change in Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples Before and After Treatment — 38.5; 48.2; 19.2; 7.4 percentage of participants — p=0.85

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: sulindac (Drug); placebo (Other)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: National Cancer Institute (NCI)
Primary completion: May 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Response Determined by Change in Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples Before and After Treatment	38.5; 48.2; 19.2; 7.4; 11.5; 7.4	0.85
SECONDARY Percent Change in Number of Dysplastic Lesions (DL) as Measured by Mucosal Biopsy Samples Before and After the Intervention	-55; -100	0.63

Summary

This randomized phase II trial is studying sulindac to see how well it works compared to a placebo in preventing lung cancer in current or former smokers with bronchial dysplasia. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of sulindac may prevent lung cancer from forming in patients with bronchial dysplasia. It is not yet known whether sulindac is more effective than a placebo in preventing lung cancer in patients with bronchial dysplasia.

Eligibility Criteria

Inclusion Criteria

Current or former smoker who has smoked at least 30 pack years AND meets 1 of the following criteria:
No prior lung cancer
Prior stage I non-small cell lung cancer(NSCLC) that was completely resected ≥ 1 year ago OR for which patient completed adjuvant chemotherapy ≥ 1 year ago
Tissue blocks, blood, and sputum samples available for research purposes
No carcinoma in situ
ECOG performance status 0-1
Hemoglobin ≥ 12.0 g/dL (women) or hemoglobin ≥ 13.5 g/dL (men)
WBC ≥ 3,000/mm³
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
ALT ≤ 1.5 times ULN
Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥30 mL/min
Room air oxygen saturation ≥ 90%
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Negative chest x-ray
Negative electrocardiogram
No other cancer within the past 3 years except nonmelanoma skin cancer, localized prostate, carcinoma in situ of the cervix cancer, or superficial bladder cancer
Treatment must have been completed > 6 months ago
No prior gastrointestinal ulceration, bleeding, or perforation
No uncontrolled illness including, but not limited to, any of the following:
Ongoing or active infection
Symptomatic congestive heart failure
Unstable angina pectoris
Cardiac arrhythmia
Myocardial infarction within the past 6 months
Chronic renal disease
Chronic liver disease
Difficult to control hypertension
Psychiatric illness or social situations that would limit study compliance
No known HIV positivity
No history of allergic reactions or hypersensitivity to sulindac or other NSAIDs, including aspirin-sensitive asthma or urticaria
No known sensitivity to yellow dye FD&C Yellow #5
No continuous or intermittent supplemental oxygen
At least 6 months since prior participation in another chemoprevention trial
At least 6 months since prior regular use of nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids (may be eligible after washout period of 12 weeks for NSAIDs and 6 weeks for corticosteroids)
No prior pneumonectomy
No prior solid organ transplantation
No other concurrent investigational agents
No concurrent regular use of acetylsalicylic acid (aspirin) unless prescribed by a physician for prevention
Maximum of 1 aspirin (81 mg) per day allowed
No concurrent use of any of the following:
Methotrexate
Corticosteroids
Antiplatelet agents:
Warfarin
Ticlopidine
Clopidogrel bisulfate
Aspirin
Abciximab
Dipyridamole
Eptifibatide
Tirofiban hydrochloride
Lithium carbonate
Cyclosporine
Hydralazine
Angiotensin-converting enzyme (ACE) inhibitors (ACE receptor antagonists are allowed)
Angiotensin receptor blockers

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00368927). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.