Study of BAY43-9006 (Sorafenib) in Combination With Carboplatin, Paclitaxel and Bevacizumab in Previously Untreated Patients With Stage IIIB (With Malignant Pleural Effusions) or Stage IV Non-small Cell Lung Cancer (NSCLC)
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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