Primary Outcome Measures:
- Progression-free survival [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Toxicity [ Designated as safety issue: Yes ]
- Changes in dynamic contrast-enhanced MRI and angiogenic parameters [ Designated as safety issue: No ]
- Response rate [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
OBJECTIVES:
Primary
- Assess the progression free survival of patients with locally advanced unresectable or metastatic hepatocellular carcinoma treated with AZD2171.
Secondary
- Determine the toxicity of this drug in these patients.
- Determine, preliminarily, the efficacy of this drug, in terms of response rate, duration of response, and overall survival, in these patients.
- Determine the blood flow changes and vascular permeability of the tumor in patients treated with this drug.
- Assess preliminary data on changes of angiogenic parameters, including circulating endothelial cells, in patients treated with this drug.
- Determine the pharmacokinetic profile of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Dynamic contrast-enhanced (DCE) MRI and CT perfusion scan of the liver are performed at baseline, 72 hours after the initial dose of AZD2171, and at the end of course 1.
Blood samples for pharmacokinetic studies are collected on days 8 and 15 of course 1 and periodically during course 2. Blood samples are also examined for soluble markers of angiogenesis and tumor markers by protein analysis.
After the completion of study treatment, patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study.