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 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT00416650
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed bronchoalveolar cell (or a variant) non-small cell lung cancer (NSCLC)
* Stage IIIB (malignant pleural or pericardial effusion) disease
* Stage IV disease
* Recurrent and/or medically inoperable disease
* Measurable or evaluable indicator lesions
* No uncontrolled CNS metastases (i.e., any known CNS lesion that is radiographically unstable, symptomatic, and/or requiring escalating doses of corticosteroids)
PATIENT CHARACTERISTICS:
* ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100%
* Life expectancy ≥ 8 weeks
* WBC ≥ 3,000/mm³
* Hemoglobin ≥ 9.0 g/dL
* Platelet count ≥ 100,000/mm³
* Bilirubin ≤ 1.0 mg/dL
* AST ≤ 2 times upper limit of normal
* Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 55 mL/min
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No significant medical history or unstable medical condition, including any of the following:
* Unstable systemic disease
* Congestive heart failure
* Recent myocardial infarction
* Unstable angina
* Active infection
* Uncontrolled hypertension
* No other active malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal cell or squamous cell skin cancer
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 3 weeks since prior radiation therapy to a major bone marrow-containing area
* At least 3 weeks since prior chemotherapy
* No more than 1 prior chemotherapy regimen for NSCLC
* No prior systemic cytotoxic chemotherapy for other malignant diseases
* No prior erlotinib hydrochloride or other agents targeting the HER family (e.g., cetuximab, trastuzumab \[Herceptin®\], or gefitinib)
* No concurrent radiotherapy or chemotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00416650
Study Brief:
Protocol Section:
NCT00416650