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

Completed · Phase 2 · Has a placebo group

Conditions studied: Precancerous Condition, Stage I Non-small Cell Lung Cancer, Tobacco Use Disorder

In brief

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.

Key facts

Study ID

NCT00368927

Run by

National Cancer Institute (NCI)

People needed

61

Starts

2006-08-01

Expected to finish

2010-12-01

Last updated by the study team

2014-05-23

Who can join

Age: 40 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• Lahey Hospital and Medical Center — Burlington, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• British Columbia — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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