Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients must have Stage IIIB (with malignant pleural effusions) or Stage IV histological or cytological confirmation of non-small cell carcinoma (excluding squamous)
Age \>/= 18 years old
Patients must have at least 1 evaluable lesion. Lesions must be evaluated by CT scan or MRI
ECOG Performance Status of 0 to 1
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of first dose:
* Hemoglobin \>/= 9.0 g/dL
* White blood cell (WBC) count \>/= 2,500/mm3
* Absolute neutrophil count (ANC) \>/= 1,500/mm3
* Platelet count \>/= 100,000/mm3
* Total bilirubin \</= 1.5 times the upper limit of normal (ULN)
* ALT and AST \</= 2.5 X ULN (\</= 5 X ULN for patients with liver involvement)
* INR \</= 1.5 and aPTT within normal limits
* Serum creatinine \</= ULN or creatinine clearance (CrCl) \>/= 45 mL/min (CrCl = Wt (kg) x (140-age)/72 x Cr level, female x 0.85) for patients with creatinine levels above institutional normal
* Urinalysis (UA) must show less than 1+ protein in urine, or the patient will require a repeat UA. If repeat UA shows 1+ protein or more, a 24 hour urine collection will be required and must show total protein \</= 1000 mg/24 hour to be eligible
You may not be if
Patients with squamous histology
Cardiac disease: Congestive heart failure \> Class II NYHA; active coronary artery disease (MI more than 6 months prior to study entry is allowed); or serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg despite optimal medical management
HIV infection or chronic hepatitis B or C
Active clinically serious infections (\> Grade 2 NCI-CTC Version 3.0)
Evidence or history of CNS disease, including primary brain tumors, seizures disorders, or any brain metastasis
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