Randomized, Controlled Biomarker Study Evaluating the Anti-angiogenic Activity of Sunitinib in Hormone Refractory Prostate Cancer Patients Treated by Docetaxel
Docetaxel (75mg/m2 q21d) is standard of care for patients with hormone refractory prostate
cancer (HRPC). Recent data indicate, that chemotherapeutics given at MTD induce, besides
their cytotoxic effects, mobilization of circulating endothelial cells (CEC) and -
progenitors (CEP) in drug-free breaks of each cycle. In preclinical models, mobilized
CEC/CEP result in tumor vasculogenesis and progression of disease.
We hypothesize that treatment with sunitinib, an anti-angiogenic tyrosine kinase inhibitor,
in between 3 weekly docetaxel disrupts CEC/CEP spikes following docetaxel leading to
chemosensitization and reduced tumor re-growth in HRPC patients responding to docetaxel.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary: CEC/CEP spikes induced by MTD docetaxel in patients treated with docetaxel/sunitinib relative to docetaxel monotherapy
Michael MK Krainer, MD
Dept of Internal Medicine I, Medical University Vienna, Austria
Austria: Agency for Health and Food Safety
MK URO 4