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:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT00729612
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed advanced non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:
* Stage IIIB disease with malignant pleural effusion
* Stage IV disease
* Recurrent disease
* Squamous cell histology allowed
* Not eligible for curative treatment or treatment with bevacizumab
* Measurable disease according to RECIST
* Tumor (paraffin blocks or slides) must be available for correlative biomarker studies
* No uncontrolled brain metastases (or leptomeningeal disease)
* Controlled brain metastases allowed
* Able to receive appropriate therapeutic radiotherapy
* Able to taper off all steroids without symptoms suggestive of increased intracranial pressure (nausea, vomiting, focal neurologic symptoms) for at least 7 days
PATIENT CHARACTERISTICS:
* ECOG (Eastern Cooperative Oncology Group) performance status 0-2
* ANC (absolute neutrophil count) ≥ 1.5 x 10\^9/L
* Platelets ≥ 100 x 10\^9/L
* Hemoglobin ≥ 9.0 g/L
* Total bilirubin ≤ 1.5 mg/dL
* AST (aspartate aminotransferase) and ALT (alanine aminotransferase) \< 2.5 times upper limit of normal
* Creatinine ≤ 1.5 mg/dL OR creatinine clearance \> 50 mg/mL
* No known HIV or hepatitis B or C
* Not pregnant
* Negative pregnancy test
* Thrombotic or embolic event within the past 6 months allowed, provided adequately controlled with therapeutic anticoagulation
* Hemoptysis allowed, provided it is not life threatening or requires palliative procedures (e.g., endobronchial therapy or radiotherapy)
* No cardiac disease, including any of the following:
* NYHA (New York Heart Association) class III-IV congestive heart failure
* Unstable angina (angina symptoms at rest)
* New onset angina (began within the past 3 months)
* Myocardial infarction within the past 6 months
* No uncontrolled hypertension, defined as systolic blood pressure (BP) \> 150 mm Hg or diastolic BP \> 90 mm Hg despite optimal medical management
* No peripheral neuropathy ≥ grade 2
* No active clinically serious infection \> CTCAE grade 2
* No serious non-healing wound, ulcer, or bone fracture
* No significant traumatic injury within the past 4 weeks
* No evidence or history of bleeding diathesis or coagulopathy
* No prior malignancy, except for adequately treated basal cell skin cancer, carcinoma in situ of the cervix, or other cancer for which the patient has been disease-free for 2 years
* Stage I (T1c) prostate cancer adequately treated 2 years prior to diagnosis of NSCLC allowed, however metastatic prostate cancer currently receiving hormonal therapy or chemotherapy is not allowed
* No significant psychiatric illness, in the opinion of the principal investigator, that would prevent adequate informed consent or render therapy unsafe
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Concurrent therapeutic anticoagulation, \> 325 mg acetylsalicylic acid, or chronic non-steroid anti-inflammatory drug use allowed
* At least 14 days since prior and no concurrent radiotherapy
* More than 4 weeks since prior major surgery or open biopsy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00729612
Study Brief:
Protocol Section:
NCT00729612