Advanced Adult Primary Liver Cancer Clinical Trial
Official title:
A Phase II Study of AZD2171 in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma
AZD2171 (cediranib maleate) may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. This phase II trial is studying how well AZD2171 works in treating patients with locally advanced or metastatic liver cancer.
PRIMARY OBJECTIVES:
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
months.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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