Gemcitabine and Oxaliplatin for Hepatocellular Carcinoma With Platelet Counts Greater Than 100,000 Per Microliter

Inclusion Criteria:

• All patients 18 years of age or older, with hepatocellular carcinoma are eligible.
• Patients must have a life expectancy of at least 12 weeks.
• Patients must have a ECOG performance status of 0-2.
• Patients must sign an informed consent.
• Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of > 1,500 or cells/mm3 and platelet count >100,000/mm3 and absence of a regular red blood cell transfusion requirement.
• Patients should have adequate hepatic function with a total bilirubin < 2 mg/dl and SGOT or SGPT < two times the upper limit of normal, and adequate renal function as defined by a serum creatinine < 1.5 x upper limit of normal.
• There must be one measurable lesion according to the RECIST criteria that should not have had prior radiation treatment.

Exclusion Criteria:

• Patients with symptomatic brain metastases that had not been adequately and definitively treated with radiation and/or surgical resection are excluded from this study.
• Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
• Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
• Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.
• Life expectancy of less than 12 weeks.
• Serious, uncontrolled concurrent infection(s)
• Any prior treatment with, Gemcitabine or Oxaliplatin .
• Completion of previous chemotherapy regimen less than 4 weeks, prior to start of this study or persistence of prior treatment related toxicity.
• Treatment for other carcinomas within the last five years, except for cured non-melanoma of the skin and treated in-situ cervical cancer.
• Participation in any investigational study within 4 weeks preceding the start of the study treatment.
• Clinically significant heart disease defined as NYHA class 3 or 4 heart disease.
• Chronic debilitating diseases that the investigator feels might compromise the study Participation.
• Evidence of inadequately treated CNS metastases.
• Major surgery within 4 weeks of the s1art of the study treatment without complete recovery.
• Known or existing uncontrolled coagulopathy.
• Any of the following laboratory parameters v) Abnormal hematological values with ANC less than 1500/mm3, thrombocytopenia less than 99,000. vi) Impaired renal function with a serum creatinine of greater than 1.5 ULN vii) Serum bilirubin greater than 1.5xULN viii) Albumin less than 2.5mg/dl.
• Unwillingness to give informed consent.
• Unwillingness to participate or inability to comply with the protocol for the duration of the study.