Spots Global Cancer Trial Database for Biomarker Study for Sunitinib and Docetaxel in Prostate Cancer
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Trial Identification
Brief Title: Biomarker Study for Sunitinib and Docetaxel in Prostate Cancer
Official Title: Randomized, Controlled Biomarker Study Evaluating the Anti-angiogenic Activity of Sunitinib in Hormone Refractory Prostate Cancer Patients Treated by Docetaxel
Study ID: NCT00795171
Conditions
Study Description
Brief Summary: Docetaxel and sunitinib will be compared to docetaxel for their effect on CEC/CEP spikes induced by docetaxel in HRPC patients
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Dept of Internal Medicine, Vienna, , Austria
Contact Details
Name: Michael MK Krainer, MD
Affiliation: Dept of Internal Medicine I, Medical University Vienna, Austria
Role: PRINCIPAL_INVESTIGATOR
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