This study will review the safety of picoplatin, a new type of platinum drug, with docetaxel, a drug commonly used in the treatment of prostate cancer. Patients who are eligible for this study will have had a diagnosis of hormone-refractory prostate cancer that has metastasized to other areas of the body, and have not been previously treated with chemotherapy drugs. Picoplatin will be administered in combination with docetaxel and prednisone to identify the maximum tolerated dose (MTD). Patients will receive IV treatments of picoplatin with docetaxel every 3 weeks, with prednisone, 5 mg orally, twice daily.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
95
The treatment regimen will be the assigned dose of picoplatin plus docetaxel, 60 mg/m2 or 75 mg/m2, once every three weeks, plus prednisone (or prednisolone, if prednisone is not available), 5 mg orally twice daily beginning on day 1 and continuing daily until therapy is discontinued. Docetaxel will be given intravenously over 60 minutes, followed 30 minutes later by picoplatin as a 1-2 hour intravenous infusion.
The treatment regimen will be the assigned dose of picoplatin plus docetaxel, 60 mg/m2 or 75 mg/m2, once every three weeks, plus prednisone (or prednisolone, if prednisone is not available), 5 mg orally twice daily beginning on day 1 and continuing daily until therapy is discontinued. Docetaxel will be given intravenously over 60 minutes, followed 30 minutes later by picoplatin as a 1-2 hour intravenous infusion.
Medical Radiology Research Center under the Russian Academy of Medical Sciences
Obninsk, Kaluga Oblast, Russia
Chelyabinsk Regional Oncology Center
Chelyabinsk, Russia
Burdenko Central Military Clinical Hospital
Moscow, Russia
Russian Research Center of Radiology
Moscow, Russia
Research Institute of Urology - Ministry of Health
Moscow, Russia
Leningrad Regional Oncology Center
Saint Petersburg, Russia
Central Medical Unit #122
Saint Petersburg, Russia
Therapeutic and Research Medical Center
Saint Petersburg, Russia
St. Petersburg City Hospital #26
Saint Petersburg, Russia
St. Petersburg City Oncology Center
Saint Petersburg, Russia
...and 1 more locations
In Part 1, the Maximum Tolerated Dose (MTD) will be determined
Time frame: MTD
In Part 2, PSA response will be measured (reduction of at least 50% of PSA from baseline, with reduction maintained for at least 4 weeks)
Time frame: response
Progression free survival
Time frame: progression
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