Clinical trial NCT00524316 (phase 2, status: terminated)
Conditions: liver cancer
ICD codes: D13.4, Z85.05, C22.8, C78.7, C22.9, D37.6
Drugs: doxorubicin hydrochloride, sunitinib malate
SMILES: COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O, CCN(CC)CCNC(=O)C1=C(C)NC(\C=C2/C(=O)NC3=C2C=C(F)C=C3)=C1C
Reason stopped: 
    low accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically, cytologically, or serologically* confirmed hepatocellular carcinoma
             meeting the following criteria:

               -  1-4 lesions

               -  Involvement of 1 or both liver lobes NOTE: *Alpha-fetoprotein (AFP) > 500 mcg/L
                  in high-risk patients

          -  Measurable disease by CT scan or MRI

               -  Disease does not exceed 50% of the liver parenchyma

               -  At least 1 lesion ≥ 3 cm in longest diameter

          -  Tumor burden involves < 50% of the liver

          -  Refused surgery OR unresectable disease due to any of the following:

               -  Multifocality

               -  Advanced cirrhosis

               -  Comorbid illness

          -  Candidate for chemoembolization

          -  No fibrolamellar histology

          -  No ascites

          -  No known brain metastases

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Life expectancy ≥ 12 weeks

          -  WBC ≥ 3,000/mm³

          -  ANC ≥ 1,500/mm³

          -  Hemoglobin ≥ 8.5 g/dL (transfusion allowed)

          -  Platelet count ≥ 100,000/mm³

          -  Bilirubin ≤ 2 mg/dL

          -  AST ≤ 5 times upper limit of normal (ULN)

          -  INR < 1.5

          -  Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 30 mL/min

          -  No bleeding diathesis or coagulopathy

          -  No active congestive heart failure

          -  No uncontrolled angina

          -  No myocardial infarction within the past 12 months

          -  No cardiac arrhythmia

          -  Ejection fraction ≥ 45% (in patients with known coronary artery disease and in
             patients > 50 years of age)

          -  Child-Pugh class A or B cirrhosis

          -  No impedance of hepatopedal blood flow (portal vein thrombosis)

          -  No thrombosis of the main portal vein

          -  No encephalopathy

          -  No biliary obstruction

          -  No variceal bleed within the past 6 months

          -  No history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to sunitinib malate

          -  No absolute contraindication to doxorubicin, iodinated contrast material,
             microfibrillar collage hemostat, or dexamethasone

          -  No other concurrent uncontrolled illness including, but not limited to, any of the
             following:

               -  Ongoing or active infection

               -  Psychiatric illness or social situation that would limit compliance with study
                  requirements

          -  No other active malignancies within the past year except nonmelanoma skin cancer or
             carcinoma in situ

          -  No significant traumatic injury within the past 4 weeks

          -  No QTc prolongation (i.e., QTc interval ≥ 500 msec) or other significant ECG
             abnormalities

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 6 months after the
             completion of study treatment

        PRIOR CONCURRENT THERAPY:

          -  Recovered from prior therapy

          -  Prior liver-directed therapy, such as chemoembolization, radiofrequency ablation,
             cryoablation, or ethanol injection allowed if the following criteria are met:

               -  Treated lesion remains inactive by CT scan or MRI and new lesion being embolized
                  is distinct from the previously treated lesion

               -  Radiographic progression of previously treated lesion requiring re-embolization

          -  Prior liver resection allowed

          -  Prior immunotherapy allowed

          -  No prior antiangiogenesis therapy

          -  No prior liver transplantation

               -  Patients awaiting a cadaveric or orthotopic liver transplantation are eligible
                  provided they have end-stage liver disease with a priority score of < 20 points

          -  More than 4 weeks since prior radiotherapy or chemotherapy (6 weeks for nitrosoureas
             or mitomycin C)

          -  More than 4 weeks since prior major surgery or open biopsy

          -  At least 1 week since prior fine needle biopsy

          -  No concurrent immunotherapy

          -  No concurrent radiotherapy

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No concurrent therapeutic doses of coumarin-derivative anticoagulants (e.g., warfarin)

               -  Doses of ≤ 1 mg/day are allowed for prophylaxis of thrombosis as long as INR ≤
                  1.5

               -  Both full dose and prophylactic dose low molecular weight heparin allowed as long
                  as PT INR ≤ 1.5

          -  No anticipated major surgery during and for 3 months after completion of study
             treatment

          -  No other concurrent investigational agents

          -  No other concurrent anticancer therapy