Clinical trial NCT01182272 (phase 2, status: unknown status)
Conditions: liver cancer
ICD codes: D13.4, Z85.05, C22.8, C78.7, C22.9, D37.6
Drugs: sorafenib tosylate
SMILES: CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed hepatocellular carcinoma (HCC)

               -  Fibrolamellar or mixed histology allowed

               -  No cholangiocarcinoma or other tubal disease

          -  Must be eligible for conservative hepatic resection or liver resection with curative
             intent

          -  No cirrhosis with Child-Pugh score > 7

          -  Chronic liver disease without liver insufficiency and without portal liver
             hypertension allowed

          -  No known history or presence of metastatic brain or meningeal tumors

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  Life expectancy ≥ 3 months

          -  WBC > 3,000/µL

          -  ANC > 1,500/µL

          -  Platelet count ≥ 100,000/µL

          -  Hemoglobin ≥ 9 g/dL

          -  Bilirubin < 1.5 times upper normal limit (ULN)

          -  AST and ALT ≤ 5 times UNL

          -  Alkaline phosphatase ≤ 5 times ULN

          -  Serum creatinine < 2 times ULN

          -  PT/INR/PTT < 1.5 times UNL

          -  Amylase and lipase < 1.5 times ULN

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Body mass index 18.5-30 kg/m^2 (WHO normal range: 18.5-25 kg/m^2)

          -  Able to swallow oral compound

          -  No criterion for unresectability or medical condition that contraindicates surgical
             resection

          -  No serious concurrent systemic disorder incompatible with the study, including any of
             the following:

               -  Uncontrolled hypertension (i.e., BP > 150/100 mm Hg despite optimal therapy)

               -  Active uncontrolled infection

               -  Active alcoholism

          -  No prior medical disorder, including any of the following:

               -  Cardiac arrhythmias requiring anti-arrhythmics (excluding beta-blockers or
                  digoxin for chronic atrial fibrillation)

               -  Active coronary artery disease or ischemia

               -  Myocardial infarction within the past 6 months

               -  NYHA class III-IV congestive heart failure

               -  Pulmonary embolism within the past 6 months

               -  Gastrointestinal bleeding within the past 6 months

          -  No other prior malignancy within the past 5 years, except basal cell or squamous cell
             skin carcinoma or cured in situ cervical carcinoma

          -  No history or concurrent seizure disorder requiring medications (e.g., antiepileptic
             drugs)

          -  No history of HIV infection, or chronic hepatitis B or C

          -  No active clinically serious bacterial or fungal infection (i.e., grade 2 CTCAE v. 3)

          -  No condition that is unstable or could jeopardize the safety of the patient and
             his/her compliance with the study

          -  No substance abuse or medical, psychological, or social condition that could interfere
             with adherence to the study

          -  No known or suspected allergy to the investigational agent or to any agent given
             concurrently

          -  No presence of asthenia or rash > CTC grade 1 at enrollment

          -  Must be registered in a national health-care system

        PRIOR CONCURRENT THERAPY:

          -  No prior orthotopic liver transplantation

          -  Not a candidate for orthotopic liver transplantation

          -  No prior systemic or loco-regional treatment for HCC

          -  No prior organ allograft

          -  No treatment with any other investigational medicinal product within the past 28 days

          -  No concurrent treatment with full-dose anticoagulants

               -  Deep-vein or catheter-associated thrombosis prophylaxis allowed

               -  Warfarin or heparin therapy allowed if the coagulation parameters were within the
                  acceptable ranges prior to initiation of anticoagulant therapy

          -  No concurrent or chronic co-administration of CYP3A4 inducers (e.g., rifampin,
             Hypericum perforatum, phenytoin, carbamazepine, phenobarbital, or dexamethasone)