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Brief Title: A Study of Picoplatin and Docetaxel in Subjects With Prostate Cancer
Official Title: A Phase 1/2 Study of Picoplatin and Docetaxel (With Prednisone) in Subjects With Chemotherapy-Naive Metastatic Hormone-Refractory Prostate Cancer
Study ID: NCT00448734
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Medical Radiology Research Center under the Russian Academy of Medical Sciences, Obninsk, Kaluga Region, Russian Federation
Chelyabinsk Regional Oncology Center, Chelyabinsk, , Russian Federation
Burdenko Central Military Clinical Hospital, Moscow, , Russian Federation
Russian Research Center of Radiology, Moscow, , Russian Federation
Research Institute of Urology - Ministry of Health, Moscow, , Russian Federation
Leningrad Regional Oncology Center, St. Petersburg, , Russian Federation
Central Medical Unit #122, St. Petersburg, , Russian Federation
Therapeutic and Research Medical Center, St. Petersburg, , Russian Federation
St. Petersburg City Hospital #26, St. Petersburg, , Russian Federation
St. Petersburg City Oncology Center, St. Petersburg, , Russian Federation
State Medical Institution of Yaroslavl Region / Regional Clinical Oncology Hospital, Yaroslavl, , Russian Federation
Name: Robert Earhart, MD
Affiliation: Poniard Pharmaceuticals
Role: STUDY_DIRECTOR