Trial Information
Summary: Phase 2 Research Study Investigating the Safety and Effectiveness of ZK-Epothilone in Patients with Metastatic prostate cancer
This study plans to look at the safety and effectiveness of an
investigational therapy in patients with metastatic prostate
cancer.
This is a phase 2 research study investigating the effectiveness
and safety of ZK-Epothilone (ZK-Epo) in combination with prednisone
as a chemotherapy in patients with Metastatic prostate cancer.
ZK-Epo is an Epothilone, a new class of chemotherapy that has
demonstrated activity against several tumor types in pre-clinical
studies.
To date, ZK-Epo has been given to more than 200 cancer patients.
These patients have been enrolled in studies of solid tumor cancers
such as prostate cancer, breast cancer, ovarian cancer, lung
cancer, and head and neck cancers.
Eligible participants for this study must have been diagnosed
with metastatic prostate cancer and are no longer responding to
hormone treatments such as: Lupron® , Eligard®, goserelin
(Zoladex®), triptorelin (Trelstar® ), and abarelix (Plenaxis®
).
The study will involve approximately 46 patients at 15
participating sites across the US and Argentina. All eligible
patients will receive active study drug. The study drug will be
given every 3 weeks for up to 18 weeks. All patients will be asked
to return to the clinic every week while they are receiving study
drug and then monthly for 3 months after their last dose of study
drug.
Patients entered in the clinical trial will receive
trial-related medical care and study drug at no charge.
Patients must meet the following criteria to enroll in
this study:
- Men, 18 years of age or older
- Have metastatic prostate cancer
- Have NOT previously received chemotherapy
- Have a rising PSA (prostate specific antigen) level
For additional information please contact the Patient Info line
at:
1-877-919-5376, or log on to
www.prostate.zkepo.com
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Contact:
Study Coordinator
Florida Urology Specialists
Located in:
Sarasota, FL
Telephone: 1-877-919-5376
|
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Trial listings updated: June 1, 2008 at 6:30:25 AM