| Exclusion Criteria: | 1) Cardiac disease: Congestive heart failure (CHF) > Class II NYHA; active coronary artery disease (Myocardial infarction [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)
2) Uncontrolled hypertension defined as systolic blood pressure > 140 mmHg or diastolic pressure > 85 mmHg despite optimal medical management
3) Known history of Human Immunodeficiency Virus (HIV) infection or chronic hepatitis B or C
4) Active clinically serious infections (i.e. patients currently taking antibiotics)( Grade 2 NCI-CTC Version 3.0)
5) Evidence or history of central nervous system (CNS) disease, including primary brain tumors, seizures disorders, or any brain metastasis
6) Thrombotic or embolic events such as cerebrovascular accident, deep vein thrombosis or pulmonary embolism. History of transient ischemic attack is allowed.
7) Evidence or history of bleeding diasthesis or coagulopathy
8) History of/or current evidence of hemoptysis (bright red blood of ½ teaspoon or more)
9) Peripheral neuropathy >/= Grade 2 (NCI-CTC Version 3.0)
10) Anticancer chemotherapy or immunotherapy: Anticancer therapy is defined as any agent or combination of agents with clinically proven anticancer activity administered by any route with the purpose of affecting the cancer, either directly or indirectly, including palliative and therapeutic endpoints
11) Radiotherapy to the target lesions within 3 weeks of start of first dose. Toxicities from radiotherapy must have resolved prior to start of first dose.
12) No major surgery, open biopsy or significant traumatic injury within 4 weeks of start of first dose
13) Serious, non-healing wound, ulcer, or bone fracture
14) Granulocyte growth factors (G-CSF), within 3 weeks of study entry.
15) Patients taking chronic erythropoietin are permitted provided no dose adjustment is made within 2 months prior to start of first dose.
16) Pregnant or breastfeeding patients
17) Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
18) Known or suspected allergy to any recombinant human antibodies, or compounds of similar chemical or biologic composition to sorafenib or any of the drugs in this study
19) Any condition that is unstable or could jeopardize the safety or compliance of the patient in the study
20) Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in the study EXCEPT cervical cancer in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis and T1) or any cancer curatively treated > 3 years prior to study entry
21) Known or suspected allergy to sorafenib (BAY 43-9006) or any agent given in association with this trial
22) Any malabsorption conditions
23) Therapeutic anticoagulation with warfarin, heparins, or heparinoids
24) Patients taking phenytoin, carbamazepine, and Phenobarbital
25) Patients taking rifampin and/or St. John's Wort
26) Patients who are candidates for curative surgery or radiotherapy
27) The patient has progressed within 6 months after completion of curative intent (definitive) treatment for localized/locoregionally advanced disease. |