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.
Interventional
Primary Purpose: Treatment
Steven R. Alberts, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000068019
NCT00006010
September 2001
Name | Location |
---|---|
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
MBCCOP - Hawaii | Honolulu, Hawaii 96813 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Duluth | Duluth, Minnesota 55805 |
CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
CCOP - Geisinger Clinic and Medical Center | Danville, Pennsylvania 17822-2001 |
CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
Mayo Clinic | Jacksonville, Florida 32224 |
Medcenter One Health System | Bismarck, North Dakota 58501 |