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Phase II Trial of Gemcitabine and Docetaxel in Patients With Unresectable or Metastatic Hepatocellular Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Liver Cancer

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Trial Information

Phase II Trial of Gemcitabine and Docetaxel in Patients With Unresectable or Metastatic Hepatocellular Carcinoma


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Steven R. Alberts, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000068019

NCT ID:

NCT00006010

Start Date:

September 2001

Completion Date:

Related Keywords:

  • Liver Cancer
  • localized unresectable adult primary liver cancer
  • advanced adult primary liver cancer
  • recurrent adult primary liver cancer
  • adult primary hepatocellular carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
MBCCOP - HawaiiHonolulu, Hawaii  96813
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Mayo ClinicJacksonville, Florida  32224
Medcenter One Health SystemBismarck, North Dakota  58501