Phase II Study of Xyotax in Advanced Hormone Refractory Prostate Cancer
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 cancer; however, treatment options for a patient in whom androgen
ablation fails are limited. Docetaxel and paclitaxel, taxanes that are cell cycle specific,
play a major role in advanced hormone-refractory prostate cancer treatment. In preclinical
studies, Xyotax, a conjugate of paclitaxel with enhanced permeability and retention in tumor
tissue, has an improved therapeutic profile, with both decreased systemic drug-related
toxicities and enhanced efficacy. Xyotax as a single agent has been studied in a broad
variety of syngeneic and xenogeneic tumor models. Recognizing that taxanes are active in
prostate cancer and preclinical data reports activity with Xyotax in docetaxel and
paclitaxel resistant cell lines, there is significant rationale to develop this agent in
prostate cancer. Thus, a phase II study is needed to evaluate the antitumor activity in two
subsets of hormone refractory prostate cancer patients: those with no prior systemic and
those with one prior systemic therapy.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
PSA response
Robert J Amato, DO
Principal Investigator
The Methodist Hospital Research Institute
United States: Food and Drug Administration
PCa-X-02
NCT00446836
March 2005
January 2008
Name | Location |
---|---|
The Methodist Hospital Research Institute | Houston, Texas 77030 |