Single Arm, Non Randomized Phase II Trial of Gemcitabine and Oxaliplatin (GEM-OX) for Hepatocellular Carcinoma (HCC) Patients With Platelet Counts Greater Than 100,000 Per Microliter.
- 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.
- Patients with symptomatic brain metastases that had not been adequately and
definitively treated with radiation and/or surgical resection are excluded from this
- 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
- 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
- Clinically significant heart disease defined as NYHA class 3 or 4 heart disease.
- Chronic debilitating diseases that the investigator feels might compromise the study
- Evidence of inadequately treated CNS metastases.
- Major surgery within 4 weeks of the s1art of the study treatment without complete
- 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.