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 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT00088959
Eligibility Criteria:
Criteria:
* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) meeting 1 of the following stage criteria: Stage IIIB with pleural effusion; Stage IV disease; recurrent or progressive disease after prior surgery, radiotherapy, and/or chemotherapy
* If the sole prior treatment was in the adjuvant or neoadjuvant setting, tumor progression or recurrence must have occurred within 6 months after completion of prior treatment
* Absolute neutrophil count \>= 1,500/mm\^3
* Platelet count \>= 100,000/mm\^3
* Hemoglobin \>= 10 g/dL
* Hemostasis normal
* Creatinine =\< 2.0 mg/dL
* No significant cardiovascular disease
* No New York Heart Association class III or IV cardiac disease
* No uncontrolled dysrhythmia
* No unstable angina
* No myocardial infarction within the past 6 months
* FEV1 \>= 1.0 liter OR 40% of predicted within the past 3 months
* Oxygen saturation \>= 90% on room air
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after study treatment
* Willing to undergo bronchoscopy
* No allergy to sulfonamides or hypersensitivity reaction to celecoxib
* No other medical or psychological condition (e.g., acute psychosis) that would preclude study participation
* At least 4 weeks since prior chemotherapy (6 weeks for mitomycin)
* At least 4 weeks since prior radiotherapy
* Prior complete resection allowed provided there is histologic and cytologic documentation of disease recurrence
* More than 3 months since prior chemopreventative agents (e.g., oltipraz, retinoids, or N-acetylcysteine \[NAC\])
* No prior erlotinib hydrochloride
* No other prior EGFR antagonists
* No concurrent medication known to interact with erlotinib hydrochloride or celecoxib, including the following: Fluconazole, Lithium, Furosemide, Angiotensin-converting enzyme inhibitors, Phenytoin, Carbamazepine, Rifampin, Barbiturates, Hypericum perforatum (St. John's wort)
* No concurrent non-steroidal anti-inflammatory drugs
* Concurrent aspirin of up to an average dose of 325 mg/day allowed
* No aspirin treatment for 7 days prior to any bronchoscopic or skin biopsy
* No other concurrent EGFR inhibitors or cyclo-oxygenase-2 (COX-2) inhibitors
* Meets 1 of the following criteria: 1) Advanced NSCLC with at least stable disease after \>= 4 courses of platinum-containing chemotherapy 2) Relapsed or refractory disease after treatment with \>= 1 prior platinum-containing chemotherapy program, including adjuvant or neoadjuvant therapy for NSCLC
* No untreated brain metastases
* ECOG 0-1
* Former smoker, as indicated by the following: 1) At least a 30 pack-year smoking history 2) Smoking duration at least 10 years 3) At least 12 months of self-reported smoking cessation 4) Negative urine cotinine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00088959
Study Brief:
Protocol Section:
NCT00088959