A Phase II Study of AZD2171 in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma
I. Determine the 6-month survival of patients with locally advanced or metastatic
hepatocellular carcinoma treated with AZD2171.
SECONDARY OBJECTIVES I. Determine tumor response and time to progression in patients treated
with this drug.
II. Determine the toxicity of this drug in these patients. III. Correlate biological markers
with response in patients treated with this drug.
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. Patients achieving a complete
response (CR) receive 2 additional courses beyond CR. Patients experiencing disease
progression within 5 years after completion of study treatment may receive additional
courses of study treatment.
After completion of study treatment, patients are followed every 3 months for 1 year and
then every 6 months for 4 years.
PROJECTED ACCRUAL: A total of 20-44 patients will be accrued for this study within 22
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Survival after 6 months of treatment
Will be estimated by the proportion of patients surviving more than 6 months. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
North Central Cancer Treatment Group
United States: Food and Drug Administration
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