A Study of Oxaliplatin and Capecitabine in Unresectable Metastatic Hepatocellular Cancer
Condition: Liver Cancer; Hepatocellular Cancer
MeSH terms: Liver Neoplasms; Carcinoma, Hepatocellular
Intervention: Oxaliplatin; Capecitabine
Intervention description: Given IV; Given PO
Intervention MeSH terms: Capecitabine; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well giving oxaliplatin and capecitabine together works
      in treating patients with liver cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically confirmed hepatocellular carcinoma which is
             recurrent, metastatic or unresectable.

          -  Patients may have up to two prior chemotherapy regimes. In addition, they may have had
             previous radiation, chemoembolization, and/or alcohol injections.

          -  Patients must have measurable disease, defined as lesions that can be accurately
             measured in at least one dimension (longest diameter to be recorded) as ≥20 mm with
             conventional techniques or as ≥10 mm with spiral CT scan, and which has clearly
             progressed during the observation interval prior to participation in this study.
             Pleural effusions and ascites will not be considered measurable, but may be present in
             addition to the measurable lesion(s).

          -  Karnofsky performance status > 70%.

          -  Patients should have an expected survival of at least 2 months.

          -  Leukocytes >3,000/µl

          -  Absolute neutrophil count >1,500/µl

          -  Platelets >50,000/µl

          -  Total bilirubin < 3.0 g/dl

          -  AST (aspartate aminotransferase) (serum glutamic oxaloacetic transaminase(SGOT)/ALT
             (alanine aminotransferase) (serum glutamic pyruvic transaminase)(SGPT) < 5 times
             institutional upper limit of normal

          -  Creatinine < 2.0 OR measured or calculated creatinine clearance >60 mL/min for
             patients with creatinine levels above institutional normal

          -  Brain metastasis is not an exclusion, however, patients are only eligible if they have
             had successful control of the brain tumor(s) by surgery or stereotactic RT.

          -  Patients with no evidence of clinically significant neuropathy.

          -  All prior therapy must have been completed at least 4 weeks prior to the patient's
             entry on this trial.

          -  Women of childbearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control) 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.

          -  Breastfeeding should be discontinued if the mother is treated with oxaliplatin.

          -  Subjects with chronic hepatitis B or C may be undergoing treatment with α interferon
             and/or ribavirin, as long as they meet the other criteria for entry on to this study.

          -  Ability to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria:

          -  Patients have prior oxaliplatin or xeloda treatment or undergoing therapy with other
             investigational agents.

          -  History of allergy to platinum compounds or to antiemetics appropriate for
             administration in conjunction with protocol-directed chemotherapy.

          -  Uncontrolled intercurrent illness including, but not limited to ongoing or active
             infection, symptomatic congestive heart failure, or unstable angina pectoris, or
             cardiac arrhythmia.

          -  HIV-positive patients receiving anti-retroviral therapy (HAART) are excluded from the
             study because of possible pharmacokinetic interactions.

          -  Patients with a diagnosis of pulmonary fibrosis or a pulmonary interstitial process.

          -  Patients unable to swallow capecitabine will be excluded from this study.