NCT00795171

Biomarker Study for Sunitinib and Docetaxel in Prostate Cancer

Randomized, Controlled Biomarker Study Evaluating the Anti-angiogenic Activity of Sunitinib in Hormone Refractory Prostate Cancer Patients Treated by Docetaxel

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hormone Refractory Prostate Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel * Sunitinib	docetaxel 75mg/m2 day1 q 21d x 4 cycles, sunitinib 37.5mg/d day2 -day15 x 4 cycles
DRUG	Docetaxel	docetaxel 75mg/m2 day1 q 21d x 4 cycles
DRUG	Docetaxel	Docetaxel 75mg/m2 q21d for 4 cycles

Timeline

• Start date: 2008-11-01
• Primary completion: 2011-04-01
• Completion: 2011-07-01
• First posted: 2008-11-21
• Last updated: 2010-08-18

Locations

1 site across 1 country: Austria