Clinical trial NCT00514228 (phase 2, status: completed)
Conditions: liver cancer
ICD codes: D13.4, Z85.05, C22.8, C78.7, C22.9, D37.6
Drugs: sunitinib malate
SMILES: CCN(CC)CCNC(=O)C1=C(C)NC(\C=C2/C(=O)NC3=C2C=C(F)C=C3)=C1C
Eligibility criteria:

        DISEASE CHARACTERISTICS:

        Inclusion criteria:

          -  Histologically, cytologically, or radiologically confirmed hepatocellular carcinoma
             (HCC) meeting 1 of the following criteria:

               -  Localized, surgically unresectable disease

                    -  Candidates for radical surgery for locally advanced disease are excluded

               -  Metastatic disease

          -  Measurable disease, defined as ≥ 1 lesion, outside of pretreated areas, that can be
             measured in ≥ 1 dimension as ≥ 10 mm by spiral or multi-slice CT scan or MRI

          -  Child-Pugh class A or mildly decompensated Child-Pugh class B liver dysfunction

        Exclusion criteria:

          -  Clinical ascites of any grade

          -  Clinical symptoms or history of CNS metastases or leptomeningeal disease

          -  Known fibrolamellar HCC or mixed cholangiocarcinoma and HCC

        PATIENT CHARACTERISTICS:

        Inclusion criteria:

          -  WHO performance status 0-1

          -  Hemoglobin ≥ 9.0 g/dL

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Platelet count ≥ 75,000/mm³

          -  Bilirubin ≤ 2 times upper limit of normal (ULN)

          -  ALT ≤ 7 times ULN

          -  Albumin ≥ 2.5 g/dL

          -  Creatinine clearance ≥ 40 mL/min

          -  Quick test ≥ 50% (adequate coagulation)

          -  Urine dipstick for proteinuria < 2+ OR ≤ 1 g of protein in 24-hour urine collection

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 12 months after
             completion of study therapy

        Exclusion criteria:

          -  Pregnant or nursing

          -  Encephalopathy

          -  Malignancy within the past 5 years except for adequately treated cervical carcinoma in
             situ or localized nonmelanoma skin cancer

          -  Hemorrhagic or thrombotic cerebrovascular event in the past 12 months

          -  Documented variceal hemorrhage within the past 3 months

          -  History or presence of clinically significant acute or unstable cardiovascular,
             cerebrovascular, renal, gastrointestinal, pulmonary, immunological (except for the
             presence of hepatitis B virus, hepatitis C virus, or cirrhosis), endocrine, or central
             nervous system disorders

          -  Known HIV infection

          -  Active infection requiring IV antibiotics

          -  Arterial hypertension ≥ 150/100 mm Hg, despite therapy

          -  Ongoing cardiac dysrhythmias ≥ grade 2

          -  Atrial fibrillation of any grade

          -  Prolongation of QTc > 500 msec in screening ECG or history of familial long QT
             syndrome

          -  Inability to take oral medications

          -  Psychiatric disorder precluding understanding of information of study-related topics,
             giving informed consent, or interfering with compliance for oral drug intake

        PRIOR CONCURRENT THERAPY:

        Inclusion criteria:

          -  At least 4 weeks since prior surgery or liver-directed therapy (e.g., transarterial
             embolization/chemoembolization [limited to 5 treatments], radiofrequency ablation,
             cryoablation, radiotherapy, or percutaneous ethanol injection)

               -  Previously treated lesions must remain separate from those to be measured in the
                  present study

          -  Low-dose anticoagulants for maintenance of patency of central venous access or
             prevention of deep vein thrombosis allowed

        Exclusion criteria:

          -  Prior systemic anticancer treatment for hepatocellular carcinoma

          -  Prior organ transplantation

          -  Treatment in a clinical study within the past 30 days

          -  Concurrent full-dose anticoagulant or requirement for anticoagulant therapy

          -  Concurrent experimental drugs or other anticancer therapy

          -  Concurrent use or anticipated need for CYP3A4 inhibitors (e.g., ketoconazole,
             itraconazole, voriconazole, erythromycin, clarithromycin, and protease inhibitors)

          -  Concurrent CYP3A4 inducers (e.g., carbamazepine, continuous treatment with
             dexamethasone [> 2 mg/day for > 7 days], phenobarbital, phenytoin, rifampicin, and St
             John's wort)

               -  Concurrent antacids allowed provided they are administered > 1 hour before or > 1
                  hour after study drug

          -  Concurrent elective major surgery

          -  Concurrent radiotherapy

               -  Concurrent analgesic radiotherapy of nontarget lesions allowed