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Randomized, Controlled Biomarker Study Evaluating the Anti-angiogenic Activity of Sunitinib in Hormone Refractory Prostate Cancer Patients Treated by Docetaxel
Docetaxel and sunitinib will be compared to docetaxel for their effect on CEC/CEP spikes induced by docetaxel in HRPC patients
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.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
Dept of Internal Medicine
Vienna, Austria
Start Date
November 1, 2008
Primary Completion Date
April 1, 2011
Completion Date
July 1, 2011
Last Updated
August 18, 2010
60
ESTIMATED participants
Docetaxel * Sunitinib
DRUG
Docetaxel
DRUG
Docetaxel
DRUG
Lead Sponsor
Medical University of Vienna
NCT02955082
NCT00667199
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT00411528