Efficacy and Safety Study of Xyotax to Treat Prostate Cancer

Completed · Phase 2

Conditions studied: Prostatic Neoplasms

In brief

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.

Key facts

Study ID

NCT00446836

Run by

The Methodist Hospital Research Institute

People needed

29

Starts

2005-03-01

Expected to finish

2008-01-01

Last updated by the study team

2016-03-17

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• Baylor College of Medicine -Methodist Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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