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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Given PO
Correlative studies
Correlative studies
Cross Cancer Institute
Edmonton, Alberta, Canada
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada
London Regional Cancer Program
London, Ontario, Canada
Incidence of Durable Stable Disease, Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST)
Stable disease for a clinical benefit rate, evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: 4 weeks
Objective Response, Evaluated Using RECIST
Partial response as assessed by RECIST criteria
Time frame: 4 weeks
Progression Free Survival
Time frame: Time from start of treatment to progression, death or last contact, or last tumor assessment before the start of further antitumor therapy, assessed up to 6.5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Correlative studies
The Ottawa Hospital Cancer Centre (Ottawa Health Research Institute) Civic Campus
Ottawa, Ontario, Canada
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada