Gemcitabine Plus Docetaxel in Treating Patients With Unresectable or Metastatic Liver Cancer
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Trial of Gemcitabine and Docetaxel in Patients With Unresectable or Metastatic Hepatocellular Carcinoma|
|Study Start Date:||September 2001|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006010
|United States, Arizona|
|CCOP - Scottsdale Oncology Program|
|Scottsdale, Arizona, United States, 85259-5404|
|United States, Florida|
|Jacksonville, Florida, United States, 32224|
|United States, Georgia|
|CCOP - Atlanta Regional|
|Atlanta, Georgia, United States, 30342-1701|
|United States, Hawaii|
|MBCCOP - Hawaii|
|Honolulu, Hawaii, United States, 96813|
|United States, Illinois|
|CCOP - Illinois Oncology Research Association|
|Peoria, Illinois, United States, 61602|
|CCOP - Carle Cancer Center|
|Urbana, Illinois, United States, 61801|
|United States, Iowa|
|CCOP - Cedar Rapids Oncology Project|
|Cedar Rapids, Iowa, United States, 52403-1206|
|CCOP - Iowa Oncology Research Association|
|Des Moines, Iowa, United States, 50309-1016|
|Sioux City, Iowa, United States, 51101-1733|
|United States, Kansas|
|CCOP - Wichita|
|Wichita, Kansas, United States, 67214-3882|
|United States, Minnesota|
|CCOP - Duluth|
|Duluth, Minnesota, United States, 55805|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|United States, North Dakota|
|Medcenter One Health System|
|Bismarck, North Dakota, United States, 58501-5505|
|United States, Ohio|
|CCOP - Toledo Community Hospital|
|Toledo, Ohio, United States, 43623-3456|
|United States, Pennsylvania|
|CCOP - Geisinger Clinic and Medical Center|
|Danville, Pennsylvania, United States, 17822-2001|
|United States, South Dakota|
|CCOP - Sioux Community Cancer Consortium|
|Sioux Falls, South Dakota, United States, 57104|
|Allan Blair Cancer Centre|
|Regina, Saskatchewan, Canada, S4T 7T1|
|Study Chair:||Steven R. Alberts, MD||Mayo Clinic|