Liver Cancer Clinical Trial
Official title:
Phase II Trial of Gemcitabine and Docetaxel in Patients With Unresectable or Metastatic Hepatocellular Carcinoma
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.
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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