Sorafenib Tosylate in Treating Patients With Liver Cancer Who Have Undergone a Liver Transplant

Exclusion Criteria

• •Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma,superficial bladder tumors (Ta, Tis \& T1); any cancer curatively treated \> 3 years prior to entry is permitted
• •Renal failure requiring hemo- or peritoneal dialysis
• •History of cardiac disease: congestive heart failure \> New York Heart Association (NYHA) class 2; active coronary artery disease (CAD); cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers ordigoxin; or uncontrolled hypertension; myocardial infarction more than 6months prior to study entry is permitted
• •Active clinically serious infections \> grade 2 (National Cancer Institute -Common Terminology Criteria for Adverse Events version 3.0)
• •Known history of human immunodeficiency virus (HIV) infection
• •Known central nervous system tumors including metastatic brain disease
• •Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
• •Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
• •Known or suspected allergy to the investigational agent or any agent given in association with this trial
• •Patients unable to swallow oral medications
• •Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
• •Pregnant or breast-feeding patients; women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug; both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial
• •Prior use of any systemic anti-cancer chemotherapy for HCC
• •Prior use of systemic investigational agents for HCC
• •Prior use of Raf-kinase inhibitors (RKI), VEGF inhibitors, MEK inhibitors or Farnesyl transferase inhibitors
• •Use of biologic response modifiers, such as granulocyte colony-stimulating factor (G-CSF), within 3 weeks prior to study entry (G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity, such as febrile neutropenia, when clinically indicated or at the discretion of the investigator; however, they may not be substituted for a required dose reduction)
• •Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 1 month prior to the study or during the study
• •Autologous bone marrow transplant or stem cell rescue within four months of start of study drug
• •Concomitant treatment with rifampin and St John's wort
• •Concomitant anti-coagulation therapy with warfarin