NCT00321724

AZD2171 in Treating Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia

A Phase II Trial of AZD2171 in Relapsed/Refractory B-Cell Chronic Lymphocytic Leukemia Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• B-cell Chronic Lymphocytic Leukemia
• Refractory Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	cediranib maleate	Given orally
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2006-05-01
• Primary completion: 2007-05-01
• First posted: 2006-05-04
• Last updated: 2013-01-15

Locations

1 site across 1 country: United States