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

OBJECTIVES:

• Assess the six-month overall survival of patients with unresectable or metastatic hepatocellular carcinoma treated with gemcitabine and docetaxel.
• Determine tumor response and time to progression in this patient population treated with this regimen.
• Determine the toxicity of this regimen in these patients.
• Assess the pharmacokinetics of docetaxel in patients treated with this regimen.

OUTLINE: Patients receive docetaxel IV over 15-60 minutes and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks. Patients achieving complete response after 2 courses of therapy receive 2 additional courses of therapy. Patients with stable disease or partial response continue therapy until disease progression.

Patients are followed every 3 months for 1 year and then every 6 months for 4 years.

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