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 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT00016367
Eligibility Criteria:
DISEASE CHARACTERISTICS: Immunohistochemically confirmed p185-HER2 expressing stage IIIB (pleural effusions only) or IV non-small cell lung cancer Confirmed overexpression at least: 1+ p185-HER2 (by DAKO Hercep Test) OR 15 ng/mL serum HER2/neu shed antigen (by Human HER2 Quantitative ELISA) At least 1 site of measurable disease outside of prior radiation port Brain metastases allowed provided clinical neurologic status is stable and head CT scan is stable to improved
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Zubrod 0-2 Life expectancy: More than 12 weeks Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic: Bilirubin less than 1.5 mg/dL SGPT no greater than 1.5 times normal Renal: Creatinine clearance at least 60 mL/min Cardiovascular: No myocardial infarction within the past 6 months No unstable angina, uncontrolled congestive heart failure, or uncontrolled arrhythmia Ejection fraction at least 40% Other: No other malignancy within the past 5 years No concurrent serious infection, including post-obstructive pneumonia No more than 10% weight loss in past 3 months Not pregnant or nursing Negative pregnancy test Fertile patients must use adequate contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 3 weeks since prior radiotherapy (including radiotherapy for brain metastases) No concurrent radiotherapy to only site of measurable disease Surgery: At least 2 weeks since prior major surgery No concurrent surgery on only site of measurable disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00016367
Study Brief:
Protocol Section:
NCT00016367