Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-24 @ 9:18 PM
NCT ID:
NCT00056004
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* At high risk for dysplasia, defined by 1 of the following criteria:
* Current or former smokers who have smoked at least 30 pack-years
* Former smokers must be enrolled within 20 years of complete smoking cessation
* Patients with curatively treated stage I non-small cell lung cancer\*
* Patients with curatively treated stage I or II squamous cell carcinoma of the head and neck (limited to oral cavity, pharynx, or larynx)\* NOTE: \*At least 12 months post-curative therapy
* Histologic confirmation of mild to severe bronchial dysplasia on bronchoscopic biopsy required
* Moderate or severe atypia on sputum cytology required before bronchoscopy (not required for patients with prior lung or head and neck cancer)
* No evidence of malignancy by chest x-ray
PATIENT CHARACTERISTICS:
Age
* 18 and over (for patients with prior lung or head and neck malignancy)
* 35 and over (for all other patients)
Performance status
* SWOG 0-1
Life expectancy
* Not specified
Hematopoietic
* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10.0 g/dL
* No bleeding disorder
Hepatic
* Bilirubin no greater than upper limit of normal (ULN)
* Liver enzymes no greater than ULN
* PT/PTT no greater than ULN
* No active or chronic liver disease (even if transaminases have normalized)
Renal
* Creatinine no greater than ULN
Cardiovascular
* No unstable angina
* No uncontrolled heart failure
Pulmonary
* No significant asthma or chronic obstructive pulmonary disease requiring chronic or periodic (at least once per year) steroids for flares
* No acute or chronic respiratory failure
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Willing and able to undergo serial bronchoscopic examinations
* No ongoing alcohol use (i.e., at least 1 glass of wine, beer, or a mixed drink per day on a regular basis)
* No other medical condition that would preclude safety during study participation
* No other active or invasive malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
* No hypersensitivity to study drug or any of its inactive ingredients
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* More than 3 months since prior corticosteroids\*
* No concurrent corticosteroids\*
* No concurrent anticancer hormonal agents NOTE: \*Systemic or inhaled, including chronic administration
Radiotherapy
* No concurrent radiotherapy
Surgery
* Not specified
Other
* More than 3 months since prior lipoxygenase inhibitors\*
* More than 3 months since prior investigational agents
* More than 3 months since prior nutritional supplements (except 1 daily multivitamin)
* No concurrent nutritional supplements (except 1 daily multivitamin)
* No other concurrent lipoxygenase inhibitors\*
* No other concurrent investigational agents
* No concurrent warfarin, beta-blockers, or theophylline
* No other concurrent antineoplastic agents
* No concurrent or chronic daily use of non-steroidal anti-inflammatory agents (NSAIDS) (except cardioprotective doses of aspirin less than 100 mg/day)
* Periodic use of NSAIDS allowed
* Concurrent participation in a smoking cessation program (including use of bupropion or nicotine gum or patch) allowed NOTE: \*Systemic or inhaled, including chronic administration
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00056004
Study Brief:
Protocol Section:
NCT00056004