This phase II trial is studying how well AZD2171 works in treating patients with refractory metastatic kidney cancer. AZD2171 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.
PRIMARY OBJECTIVES: I. Determine the objective response rate in patients with refractory metastatic renal cell carcinoma treated with AZD2171. SECONDARY OBJECTIVES: I. Determine the safety and tolerability of AZD2171 in these patients. II. Determine the feasibility of performing standardized delayed contrast-enhancement-MRI correlative studies across different institutions and platforms with data-sharing capability in patients with metastatic renal cell cancer. III. Generate preliminary data regarding potential utility of pharmacogenomic and plasma/serum biomarkers of angiogenesis as predictive or prognostic markers for future investigations of AZD2171 and renal cell carcinoma. OUTLINE: This is a multicenter study. Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for 6 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Given orally
Correlative studies
University of Chicago
Chicago, Illinois, United States
Objective Response
Objective radiologic response as measured by RECIST criteria. (30% or greater shrinkage in the sum of the longest diameters of target lesions)
Time frame: Up to 6 weeks
Performance of DCE_MRI
Binary (yes/no) indicator of whether a dynamic contrast-enhanced MRI (DCE-MRI)was successfully performed.
Time frame: One month after initiating therapy
KDR
Kinase insert domain-containing vascular endothelial growth factor receptor
Time frame: Day 28 after initiation of therapy
eNOS
Endothelial nitric oxide synthase gene (eNOS). Record genotype=number of minor alleles.
Time frame: Baseline (prior to therapy)
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