Status:
UNKNOWN
Biomarker Study for Sunitinib and Docetaxel in Prostate Cancer
Lead Sponsor:
Medical University of Vienna
Conditions:
Hormone Refractory Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 effe...
Eligibility Criteria
Inclusion
- WHO performance status of 0-2.
- Histologically proven prostate adenocarcinoma.
- All patients must have prostate adenocarcinoma that is unresponsive or refractory to androgen ablation with biochemical progression
- Measurable and/or evaluable progressive disease, which is defined by one of the following three criteria:
- 25% increase in bidimensionally measurable soft tissue metastases
- Appearance of new metastatic lesions (proven by CT scan, X-ray or bone scan)
- PSA level of at least 10ng/mL, with increases on at least 2 successive occasions at least 2 weeks apart
- If the patient has been treated with antiandrogens, treatment must have been stopped at least 6 weeks prior to study randomization
Exclusion
- \- prior chemotherapy for prostate cancer
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00795171
Start Date
November 1 2008
End Date
July 1 2011
Last Update
August 18 2010
Active Locations (1)
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1
Dept of Internal Medicine
Vienna, Austria, 1090