Stage IV Renal Cell Cancer Clinical Trial
Official title:
A Phase 2 Study of AZD2171 in Progressive Unresectable, Recurrent or Metastatic Renal Cell Carcinoma (RCC)
This phase II trial studies how well cediranib maleate works in treating patients with recurrent or metastatic kidney cancer that cannot be removed by surgery. Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To assess the clinical benefit rate (objective response rate and rate of stable disease
for at least 4 months) of AZD2171 (cediranib maleate) given to patients with progressive
unresectable or, recurrent or metastatic renal cell carcinoma (RCC).
II. To assess the duration of response or stable disease, progression free, median and
overall survival rates, and safety and tolerability of AZD2171.
III. To measure baseline and post treatment levels of soluble markers of angiogenic growth
factors and receptors as well as levels of circulating endothelial cells, and correlate
these with clinical outcome.
IV. To assess changes in blood flow and vessel permeability using dynamic contrast enhanced
magnetic resonance imaging (DCE-MRI) pre and post treatment and to correlate these changes
with clinical outcome.
OUTLINE:
Patients receive cediranib maleate orally (PO) once daily (QD) on days 1-28. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 4 weeks and then every 3
months thereafter.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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