ABT-888 and Temozolomide for Liver Cancer
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: Temozolomide; ABT-888
Intervention description: Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days; ABT-888 40 mg BID PO Days 1-7 every 28 days
Intervention MeSH terms: Temozolomide; Veliparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: liver cancer; hepatocellular; temozolomide; veliparib

Summary:

      This study is for people with liver cancer (also called hepatocellular carcinoma, or HCC in
      abbreviation).

      The purpose of this study is to test the efficacy (effectiveness) of a new combination of
      drugs, ABT-888 and temozolomide for patients with liver cancer. Temozolomide acts by damaging
      deoxyribonucleic acid (DNA) in rapidly dividing cells, in other words, cancer cells. ABT-888
      inhibits an enzyme called "PARP" which helps to fix damaged DNA. By inhibiting this enzyme,
      ABT-888 prevents cancer cells from repairing the damage caused by the temozolomide and will
      hopefully increase the killing of cancer cells, and decrease the tumors in the body.

      ABT-888 is an investigational or experimental anti-cancer agent that has not yet been
      approved by the Food and Drug Administration (FDA) for use in liver cancer.

      This study will help find out what effects (good and bad) the combination of drugs,
      temozolomide and ABT-888, has on liver cancer.

      This research is being done because it is not known if ABT-888 will increase the
      effectiveness of temozolomide in liver cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathological confirmation of HCC or noninvasive criteria following AASLD guidelines

          -  Measurable or evaluable disease based on RECIST criteria

          -  Progressive disease on sorafenib or intolerance to sorafenib

          -  ECOG performance status 0-2

          -  Child Pugh Class A or B

          -  Adequate hepatic, bone marrow, and renal function

        Exclusion Criteria:

          -  Prior ABT-888 or other PARP inhibitor treatment

          -  Anticipation of need for major surgery during the study

          -  Any of the following within 6 months before enrollment: myocardial infarction,
             severe/unstable angina, congestive heart failure, or severe pulmonary disease

          -  Women who are pregnant or lactating

          -  Women and men of child-bearing potential who are not using a reliable form of
             contraception

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to ABT-888 and temozolomide

          -  Concurrent malignancy (i.e. malignancy other than hepatocellular cancer) unless 1) the
             subject has been curatively treated and disease free for at least 2 years or 2) the
             cancer was non-melanoma skin cancer or early cervical cancer.

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection (excluding active hepatitis B or C) or psychiatric illness/ social
             situations that would limit compliance with study requirements