This phase II trial is studying how well AZD2171 works in treating patients with relapsed or refractory B-cell chronic lymphocytic leukemia. AZD2171 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer cells
OBJECTIVES: 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 without AZD2171. 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 vascularity. 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 study entry.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Given orally
Correlative studies
North Central Cancer Treatment Group
Rochester, Minnesota, United States
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.
Time frame: Up to 5 years
Complete response rate estimated by the number of confirmed complete responses (CR) observed in the trial divided by the total number of evaluable patients
Exact binomial 95% confidence intervals for the true complete response rate will be calculated.
Time frame: Up to 5 years
Overall survival
Estimated using the Kaplan-Meier method.
Time frame: From the date of registration to the date of death, assessed up to 5 years
Time to progression as estimated by Kaplan-Meier method
Estimated using the Kaplan-Meier method.
Time frame: From the date of registration to the date of disease progression, assessed up to 5 years
Duration of response
Estimated using the Kaplan-Meier method.
Time frame: From the date at which the patient's objective status is first noted to be a response to the date that progression or death is documented, assessed up to 5 years
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