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:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT00590902
Eligibility Criteria:
Inclusion Criteria:
* Either bronchioloalveolar cell carcinoma or a variant thereof after review
* Clinical stage IIIB (malignant pleural or pericardial effusion) or IV or recurrent/medically inoperable disease
* Measurable or evaluable indicator lesions
* No prior or one chemotherapy regimen for NSCLC
* Three weeks since last chemotherapy, and three weeks since prior radiation therapy to a major bone-marrow containing area
* Karnofsky performance status \> or = to 80% OR ECOG performance status ≤ or = to 1
* Life expectancy \> or = to 8 weeks
* Adequate hematologic, renal and/or hepatic function: WBC \> or = to 3,000/ul, hemoglobin \> or = to 9.0 g/dl, platelet count \> or = to 100,000/ul, total bilirubin \< or = to 1.0 mg/dl, AST \< than or = to 2.5 X UNL, creatinine \< or = to 1.5 mg/dl or Clcr \> or = to 55ml/min.
* Effective contraception
Exclusion Criteria:
* Prior exposure to OSI-774 or other treatments targeting the HER family axis (e.g.-trastuzumab, ZD1839, C225, etc.)
* Two or more prior chemotherapy regimens
* Concurrent active cancer
* Uncontrolled central nervous system metastases (i.e. any known CNS lesion which is radiographically unstable, symptomatic and/or requiring escalating doses of corticosteroids)
* Pregnant or lactating women
* Malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
* Prior systemic cytotoxic chemotherapy for other malignant disease
* Significant medical history or unstable medical condition (unstable systemic disease: congestive heart failure, recent MI, unstable angina, active infection, uncontrolled hypertension).
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00590902
Study Brief:
Protocol Section:
NCT00590902