- Unresectable, histologically confirmed hepatocellular carcinoma with evident disease
limited to liver.
- Tissue from tumor must be available. This may be paraffin embedded tissue from
previous biopsy/resection or if it is not available, a repeat biopsy must be
performed. The requirement for biopsy may be waived if alpha-fetoprotein is greater
than 500 ng/mL and in the investigators opinion not explained by a concurrent hepatic
- Patients must agree to have a 20 cc blood sample drawn in addition to routine labs
with each cycle of chemotherapy.
- Patients must have measurable disease. If prior radiation therapy was administered,
measurable disease must be outside the radiation field.
- Patients must have a Zubrod performance status of 0-2.
- Patients must have a predicted life expectancy of at least 12 weeks.
- Patients must have a pre-treatment granulocyte count (i.e., segmented neutrophils +
bands) of greater than or equal to 1,500/mm3, a hemoglobin level of greater than or
equal to 9 gm/dl, and platelet count greater than or equal to 50,000/mm3. The
granulocyte requirement may be waived if in the investigator's opinion the lower
count reflects hypersplenism with adequate bone marrow reserves.
- Patients must have adequate renal function as documented by a calculated creatinine
clearance ≥ 60.
- Patients must have adequate hepatic function as documented by a serum bilirubin less
than or equal to 2x the institutional upper limit of normal, regardless of whether
patients have liver involvement secondary to tumor. Patients may not have ascites or
the ascites must be responsive to diuretics.
- Patients who have received prior chemotherapy for unresectable disease
- Patients with any active or uncontrolled infection, including known HIV infection.
(Patients with active hepatitis B will be placed on lamivudine. Patients with active
hepatitis C will be eligible if liver tests qualify (5.1.9)
- Patients with psychiatric disorders that would interfere with consent or follow-up.
Pregnant or lactating women. Men and women of reproductive potential may not
participate unless they have agreed to use an effective contraceptive method.
- Patients with any other severe concurrent disease, which in the judgment of the
investigator, would make the patient inappropriate for entry into this study.