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

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


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