A Phase II Trial of AZD2171 in Relapsed/Refractory B-Cell Chronic Lymphocytic Leukemia Patients
I. Evaluate the response rate in patients with relapsed or refractory B-cell chronic
lymphocytic leukemia (B-CLL) treated with AZD2171.
II. Evaluate the toxicity of AZD2171 in patients with relapsed or refractory B-CLL.
III. Evaluate the complete response rate, progression-free and overall survival
distributions, and duration of response in patients with relapsed or refractory B-CLL
treated with AZD2171.
IV. Assess vascular endothelial growth factor receptor-2 (VEGFR-2) protein and
phosphorylation levels in B-CLL cells using pretreatment samples and evaluate the
association between Rai stage at study entry and clinical response to AZD2171.
V. Perform preclinical testing of AZD2171 in the induction of B-CLL cell apoptosis/cell
death using pretreatment samples, and evaluate the ability to downregulate the
phosphorylation status of VEGFR-2 of B-CLL cells by comparing in vitro samples with and
VI. Study the differences in in vitro levels of B-CLL cell apoptosis/cell death and
alteration of VEGFR-2 phosphorylation using pretreatment samples with and without AZD2171
and how these differences correlate with clinical outcomes.
VII. Assess if the clinical responses are associated with changes in bone marrow
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 undergo blood sampling and biopsies at baseline and periodically throughout study
for biomarker and correlative studies.
After completion of study therapy, patients are followed periodically for up to 5 years from
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Confirmed response defined to be an objective status of complete remission [CR], nodular partial remission [nPR], and partial remission [PR]
Ninety percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
Up to 5 years
North Central Cancer Treatment Group
United States: Food and Drug Administration
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