Carcinoma, Non-Small-Cell Lung, Lung Cancer
Conditions
Keywords
Lung, cancer, NSCLC
Brief summary
To determine the tolerability, maximum tolerated dose and pharmacokinetics of this drug.
Interventions
Sorafenib 200 mg orally BID interrupted dosing
DRUGBevacizumab
Bevacizumab 2.5 mg/kg intravenously
DRUGPaclitaxel
Paclitaxel 200 mg/m² intravenously
DRUGCarboplatin
Carboplatin AUC 6 intravenously
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to define the safety profile and maximum tolerated dose (MTD) of BAY43-9006 (sorafenib) administered in combination with, carboplatin, paclitaxel and bevacizumab | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives include evaluation of pharmacokinetics, biomarkers, pharmacodynamics and tumor response of patients treated with BAY43-9006 (sorafenib) in combination with bevacizumab, paclitaxel and carboplatin | 2 years |
Countries
United States
Outcome results
None listed