Bevacizumab and Chemoembolization in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Intervention: bevacizumab; chemotherapy; embolization therapy; hepatic artery infusion
Intervention MeSH terms: Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: localized unresectable adult primary liver cancer; adult primary hepatocellular carcinoma; advanced adult primary liver cancer; recurrent adult primary liver cancer

Summary:

      RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different
      ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
      help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the
      growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy work in
      different ways to stop the growth of tumor cells, either by killing the cells or by stopping
      them from dividing. Chemoembolization kills tumor cells by carrying chemotherapy drugs
      directly into the tumor and blocking the blood flow to the tumor. Giving bevacizumab together
      with chemoembolization may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving bevacizumab together with
      chemoembolization works in treating patients with liver cancer that cannot be removed by
      surgery.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed* hepatocellular carcinoma

               -  Unresectable disease

               -  Child's class A or B with liver-predominant and asymptomatic extrahepatic disease
                  NOTE: *A highly suspicious liver mass on CT scan or MRI in the presence of alpha
                  fetoprotein > 200 mg/dL may be used as alternative diagnostic criterion

        PATIENT CHARACTERISTICS:

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Absolute neutrophil count > 1,500/mm³

          -  Platelet count > 50,000/mm³

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 5.0 times upper
             limit of normal (ULN)

          -  Bilirubin ≤ 5.0 mg/dL

          -  Creatinine normal OR creatinine clearance > 50 mL/min

          -  No significant traumatic injury within the past 28 days

          -  No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
             the past 6 months

          -  No serious, nonhealing wound, ulcer, or bone fracture

        PRIOR CONCURRENT THERAPY:

          -  No major surgery or open biopsy within the past 28 days

          -  No minor surgery (e.g., fine-needle aspirations or core biopsies) within the past 7
             days

          -  No chemotherapy within the past 4 weeks

          -  No radiotherapy within the past 21 days

          -  No concurrent major surgery

          -  No other concurrent chemotherapy

          -  No other concurrent investigational drugs