RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of gemcitabine plus docetaxel in treating patients who have unresectable or metastatic liver cancer.

Condition	Treatment or Intervention	Phase
localized unresectable adult primary liver cancer advanced adult primary liver cancer recurrent adult primary liver cancer adult primary hepatocellular carcinoma	Drug: docetaxel  Drug: gemcitabine  Procedure: chemotherapy	Phase II

Further Study Details: 

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.

PROJECTED ACCRUAL: A total of 22-40 patients will be accrued for this study within 1-2.5 years.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Arizona
      CCOP - Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States
Florida
      Mayo Clinic, Jacksonville,  Florida,  32224,  United States
Georgia
      CCOP - Atlanta Regional, Atlanta,  Georgia,  30342-1701,  United States
Hawaii
      MBCCOP - Hawaii, Honolulu,  Hawaii,  96813,  United States
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States
      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61602,  United States
Iowa
      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States
      Siouxland Hematology-Oncology, Sioux City,  Iowa,  51101-1733,  United States
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States
Minnesota
      CCOP - Duluth, Duluth,  Minnesota,  55805,  United States
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
North Dakota
      Medcenter One Health System, Bismarck,  North Dakota,  58501-5505,  United States
Ohio
      CCOP - Toledo Community Hospital, Toledo,  Ohio,  43623-3456,  United States
Pennsylvania
      CCOP - Geisinger Clinic and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States
South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57104,  United States
Canada, Saskatchewan
      Allan Blair Cancer Centre, Regina,  Saskatchewan,  S4T 7T1,  Canada

Study chairs or principal investigators

Steven R. Alberts, MD,  Study Chair,  Mayo Clinic Cancer Center   

Study ID Numbers:  CDR0000068019; NCCTG-N0041
Record last reviewed:  January 2004
Last Updated:  October 13, 2004
Record first received:  July 5, 2000
ClinicalTrials.gov Identifier:  NCT00006010
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08