The purpose of this study is to evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) given with prednisone in patients with androgen-independent prostate cancer, who have not had previous chemotherapy, is safe and helps to decrease PSA (Prostate-specific antigen) levels.
This study has previously been posted by Berlex, Inc. and Schering AG, Germany.Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer HealthCare Pharmaceuticals, Inc.and Bayer Schering Pharma AG, Germany are the sponsors of the trial.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Chemotherapy for hormone refractory prostate cancer; 16mg/m2 (up to 32mg/m2 max) IV on day 1 or each 21 day cycle for 6 cycles or until progression or unacceptable toxicity.
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Fountain Valley, California, United States
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Sarasota, Florida, United States
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Baltimore, Maryland, United States
PSA Response to treatment with ZK-Epo plus prednisone after 6 cycles
Time frame: at least 28 days post day 21 of last cycle of treatment
Safety & Tolerability of ZK-Epo plus prednisone
Time frame: until progression, unknown duration
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Ann Arbor, Michigan, United States
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Billings, Montana, United States
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Omaha, Nebraska, United States
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The Bronx, New York, United States
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Canton, Ohio, United States
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Portland, Oregon, United States
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Altoona, Pennsylvania, United States
...and 7 more locations