Status:
COMPLETED
Efficacy and Safety Study of Xyotax to Treat Prostate Cancer
Lead Sponsor:
The Methodist Hospital Research Institute
Collaborating Sponsors:
Cellular Therapeutics
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether Xyotax, a conjugate of the taxane drug paclitaxel, is effective in the treatment of prostate cancer that is no longer responsive to hormone therapy.
Detailed Description
Prostate cancer is the second leading cause of cancer death in American men. Hormonal ablation, in the form of medical or surgical castration, is the cornerstone of management for metastatic prostate ...
Eligibility Criteria
Inclusion
- Progressing adenocarcinoma of the prostate having failed prior hormone therapy
- Free of serious co-morbidity
- Have a life expectancy of ≥ 24 weeks
- Maintaining castrate status (either surgically or hormonally)
Exclusion
- Patients with central nervous system metastases, except those patients who have had excision or radiotherapy and remain asymptomatic, off steroids and with no evidence of disease as shown by MRI for at least 6 months
- Patients known to be HIV positive
- Patients with active autoimmune disease
- Patients involving concurrent anticancer drug therapy
- Patients with unstable medical condition, such as uncontrolled diabetes mellitus or hypertension; active infections requiring systemic antibiotics, antivirals, or antifungals; clinical evidence of cardiac or pulmonary dysfunction including, but not limited to: unstable CHF, uncontrolled arrhythmias, unstable coagulation disorders, or recent myocardial infarction (within 6 months)
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00446836
Start Date
March 1 2005
End Date
January 1 2008
Last Update
March 17 2016
Active Locations (1)
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1
Baylor College of Medicine -Methodist Hospital
Houston, Texas, United States, 77030