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 inflammatory process. 
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. 

NCT00183885_inc_T1
Qualifier
Unresectable
NCT00183885_inc_T2
Condition
hepatocellular carcinoma
NCT00183885_inc_T3
Measurement
histologically
NCT00183885_inc_T4
Value
confirmed
NCT00183885_inc_T5
Qualifier
disease limited to liver
NCT00183885_inc_T6
Procedure
biopsy
NCT00183885_inc_T7
Measurement
alpha-fetoprotein
NCT00183885_inc_T8
Value
greater than 500 ng/mL
NCT00183885_inc_T9
Qualifier
measurable disease
NCT00183885_inc_T10
Procedure
radiation therapy
NCT00183885_inc_T11
Qualifier
measurable disease
NCT00183885_inc_T12
Qualifier
outside the radiation field
NCT00183885_inc_T13
Measurement
Zubrod performance status
NCT00183885_inc_T14
Value
0-2
NCT00183885_inc_T15
Measurement
predicted life expectancy
NCT00183885_inc_T16
Value
at least 12 weeks
NCT00183885_inc_T17
Measurement
granulocyte count
NCT00183885_inc_T18
Temporal
pre-treatment
NCT00183885_inc_T19
Measurement
segmented neutrophils + bands
NCT00183885_inc_T20
Value
greater than or equal to 1,500/mm3
NCT00183885_inc_T21
Measurement
hemoglobin level
NCT00183885_inc_T22
Value
greater than or equal to 9 gm/dl
NCT00183885_inc_T23
Measurement
platelet count
NCT00183885_inc_T24
Value
greater than or equal to 50,000/mm3
NCT00183885_inc_T25
Scope
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
NCT00183885_inc_T26
Measurement
renal function
NCT00183885_inc_T27
Value
adequate
NCT00183885_inc_T28
Measurement
calculated creatinine clearance
NCT00183885_inc_T29
Value
≥ 60
NCT00183885_inc_T30
Measurement
hepatic function
NCT00183885_inc_T31
Value
adequate
NCT00183885_inc_T32
Measurement
serum bilirubin
NCT00183885_inc_T33
Value
less than or equal to 2x the institutional upper limit of normal
NCT00183885_inc_T34
Condition
ascites
NCT00183885_inc_T35
Negation
may not have
NCT00183885_inc_T36
Condition
ascites
NCT00183885_inc_T37
Qualifier
responsive to diuretics
NCT00183885_inc_T38
Procedure
blood sample drawn
NCT00183885_inc_T39
Qualifier
20 cc
NCT00183885_inc_T41
Procedure
routine labs
NCT00183885_inc_T42
Multiplier
with each cycle of chemotherapy
NCT00183885_inc_T43
Scope
20 cc blood sample drawn in addition to routine labs