Hormone Refractory Prostate Cancer Clinical Trial
Official title:
A Phase II Study of Patupilone (EPO906A) as a Second Line Chemotherapy in Patients With Hormone Refractory Prostate Cancer
The purpose of this study is to determine the efficacy of patupilone chemotherapy and to find out what effects (good and bad) the drug Patupilone has on patients with prostate cancer that has progressed following hormone treatment and docetaxel chemotherapy.
Prostate cancer is the most common cancer diagnosed and the second most common cause of
cancer death in men in North America (Jemal 2003). Many patients with localized disease have
an excellent long-term survival and high cure rates with standard approaches (D'Amico 1998).
However, patients with high risk, locally advanced and metastatic disease have a poor
prognosis, and although hormonal therapy in the form of medical or surgical castration can
induce significant long-term remissions,development of androgen independent disease is
inevitable. Androgen independent (AI) disease, also termed hormone refractory prostate
cancer (HRPC), is clinically detected by a rise in prostate specific antigen (PSA) and
worsening of symptoms. Once patients reach this stage, therapeutic options are limited and
prognosis is poor
Patients with hormone refractory prostate cancer after docetaxel chemotherapy have limited
treatment options and no treatment has been proven to be efficacious. Because of the
mechanism of action and the activity of anti-microtubule agents and combinations in general
for HRPC, patupilone has potential for therapeutic activity in patients with HRPC that have
progressed after first line docetaxel chemotherapy.
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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