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