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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Given orally
Correlative studies
North Central Cancer Treatment Group
Rochester, Minnesota, United States
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.
Time frame: 6 months
Time to disease progression
Will be estimated using the method of Kaplan-Meier.
Time frame: From registration to documentation of disease progression, assessed up to 5 years
Confirmed tumor response is defined to be a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart
Time frame: Up to 5 years
Laboratory measures
Descriptive statistics will be computed for the laboratory measures, including frequency and Cox proportional hazards modeling.
Time frame: Up to 5 years
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