Gemcitabine Plus Docetaxel in Treating Patients With Unresectable or Metastatic Liver Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed unresectable or metastatic hepatocellular carcinoma not amenable to combined radiotherapy and chemotherapy or orthotopic liver transplantation
• •Measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension as at least 20 mm
• •Evidence of disease progression by serial imaging or biochemical evidence of a rising alpha-fetoprotein by serial testing
• •No history of brain or other CNS metastases not amenable to local therapy
• •* Locally treatable CNS lesions (i.e., lesions treatable with surgery or radiosurgery) allowed if no evidence of CNS progression for at least 4 weeks after completion of therapy
• •PATIENT CHARACTERISTICS:
• •Age
• •18 and over
• •Performance status
• •ECOG 0-2
• •Life expectancy
• •Not specified
• •Hematopoietic
• •Absolute neutrophil count at least 1,500/mm\^3
• •Platelet count at least 100,000/mm\^3
• •Hemoglobin at least 10.0 g/dL
• •Hepatic
• •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• •AST no greater than 2.5 times ULN
• •Renal
• •Creatinine no greater than 1.5 times ULN
• •Other
• •No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •No prior hypersensitivity reaction to taxanes or other drugs formulated with polysorbate 80
• •No grade 2 or greater peripheral neuropathy
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •At least 4 weeks since prior biologic therapy or immunotherapy
• •No concurrent immunotherapy
• •Chemotherapy
• •See Disease Characteristics
• •Prior chemotherapy (excluding gemcitabine) for radiosensitization allowed
• •At least 4 weeks since prior chemotherapy
• •At least 6 months since prior chemoembolization
• •No prior chemotherapy for metastatic disease
• •No other concurrent chemotherapy
• •Endocrine therapy
• •At least 4 weeks since prior hormonal therapy
• •Radiotherapy
• •See Disease Characteristics
• •At least 4 weeks since prior radiotherapy
• •No prior radiotherapy to 25% or more of bone marrow
• •No concurrent radiotherapy
• •Surgery
• •See Disease Characteristics