Sunitinib Malate and Capecitabine in Treating Patients With Unresectable or Metastatic Liver Cancer
Condition: Adult Primary Hepatocellular Carcinoma; Advanced Adult Primary Liver Cancer; Localized Unresectable Adult Primary Liver Cancer; Recurrent Adult Primary Liver Cancer
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms
Intervention: sunitinib malate; capecitabine
Intervention description: Given PO; Given PO
Intervention MeSH terms: Capecitabine; Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well giving sunitinib malate together with capecitabine works
      in treating patients with unresectable or metastatic liver cancer. Sunitinib malate may stop
      the growth of tumor cells by blocking some of the enzymes needed for cell growth and by
      blocking blood flow to the tumor. Drugs used in chemotherapy, such as capecitabine, work in
      different ways to stop the growth of tumor cells, either by killing the cells or by stopping
      them from dividing. Giving sunitinib malate together with capecitabine may kill more tumor
      cells
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed diagnosis of hepatocellular carcinoma (HCC) OR meets
             radiographic criteria for diagnosis of HCC without biopsy

          -  Liver mass at least 1 cm up to 2 cm in size: classic enhancement on 2 approved imaging
             modalities

          -  Liver mass > 2 cm in size: classic enhancement on 1 approved imaging modality

          -  At least one site of bidimensional measurable disease with the longest axis >= 20mm by
             conventional computed tomography (CT) scan or >= 10mm by spiral CT scan or >= 10mm by
             magnetic resonance imaging (MRI)

          -  Not eligible for curative intent surgery and not eligible for, or not willing to
             undergo, orthotopic liver transplantation

          -  Patient has received =< 1 prior systemic therapy

          -  Patient has completed treatment with surgery at least 4 weeks prior to study drug
             administration

          -  Patient has completed other cancer directed treatments including systemic
             chemotherapy, transarterial chemotherapy, transarterial chemoembolization or bland
             embolization, targeted therapy, radiotherapy, or treatment with other investigational
             anti-cancer agents at least 4 weeks prior to study drug administration AND has
             radiographic evidence of disease progression following these treatments

          -  Life expectancy of greater than 12 weeks

          -  Child-Pugh class A or B

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Karnofsky >
             60%)

          -  Platelet count >= 75,000/mm^3

          -  Absolute neutrophil count >= 1,500/mm^3

          -  Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =< 5 times upper limit
             of normal (ULN)

          -  Total bilirubin =< 3 times ULN

          -  Calculated or measured creatinine clearance >= 40 mL/min

          -  Prothrombin time =< 1.5 international normalized ratio (INR)

          -  Women of child-bearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) prior to study entry and for
             the duration of study participation; should a woman become pregnant or suspect she is
             pregnant while participating in this study, she should inform her treating physician
             immediately

          -  Ability to understand and the willingness to sign a written informed consent document
             and comply with scheduled visits, treatment plan, laboratory testing, and other trial
             procedures

        Exclusion Criteria:

          -  History of another cancer within the last 5 years with the exception of localized
             basal or squamous cell carcinoma of the skin or stage 1A cervical cancer

          -  Known brain metastases, spinal cord compression, or evidence of symptomatic brain or
             leptomeningeal carcinomatosis on screening CT or MRI scan

          -  National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE)
             version 3.0 Grade 2 variceal bleed within 6 weeks of registration or Grade 3 other
             bleed within 4 weeks of registration

          -  Any of the following within the 6 months prior to registration: myocardial infarction,
             severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic
             congestive heart failure, cerebrovascular accident or transient ischemic attack, or
             pulmonary embolism

          -  Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 Grade 2

          -  Prolonged QTc interval on baseline electrocardiograph (EKG)

          -  Uncontrolled Hypertension (> 150/100 mm Hg despite optimal medical therapy)

          -  Severe hepatic impairment, defined as Childs-Pugh Class C

          -  Pre-existing thyroid abnormality with thyroid function that cannot be maintained in
             the normal range with medication

          -  Concurrent treatment on another clinical trial; supportive care trials or
             non-treatment trials, e.g. quality of life (QOL), are allowed

          -  Pregnancy or breastfeeding; female subjects must be surgically sterile or be
             postmenopausal, or must agree to use effective contraception during the period of
             therapy; all female subjects with reproductive potential must have a negative
             pregnancy test (serum or urine) prior to enrollment; male subjects must be surgically
             sterile or must agree to use effective contraception during the period of therapy; the
             definition of effective contraception will be based on the judgment of the principal
             investigator or a designated associate

          -  Other severe acute or chronic medical or psychiatric condition or laboratory
             abnormality that may increase the risk associated with study participation or study
             drug administration, or may interfere with the interpretation of study results, and in
             the judgment of the investigator would make the subject inappropriate for entry into
             this study

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to sunitinib or capecitabine