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Brief Title: Study of Irofulven in Patients With Hormone-refractory Prostate Cancer
Official Title: Three-Arm Randomized Phase II Clinical Study of Irofulven/Prednisone, Irofulven/Capecitabine/Prednisone or Mitoxantrone/Prednisone in Docetaxel-Pretreated Hormone-Refractory Prostate Cancer Patients
Study ID: NCT00124566
Brief Summary: The purpose of this study is to assess the efficacy and safety of irofulven-based regimens compared to mitoxantrone plus prednisone in patients with hormone-refractory prostate cancer (HRPC) whose disease has progressed following Taxotere based regimens.
Detailed Description: For every five patients randomized, two will receive treatment number 1 (irofulven + prednisone), two patients will receive treatment number 2 (irofulven + capecitabine (Xeloda®) + prednisone), and one patient will receive treatment number 3 (mitoxantrone + prednisone). This is not a blinded study, so both the patient and doctor will know which treatment has been assigned.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
, Hot Springs, Arkansas, United States
, Jonesboro, Arkansas, United States
, Greenbrae, California, United States
, Colorado Springs, Colorado, United States
, Bonita Springs, Florida, United States
, Bradenton, Florida, United States
, Cape Coral, Florida, United States
, Ft. Meyers, Florida, United States
, Naples, Florida, United States
, Port Charlotte, Florida, United States
, Sarasota, Florida, United States
, Venice, Florida, United States
, Atlanta, Georgia, United States
, Augusta, Georgia, United States
, Macon, Georgia, United States
, Marietta, Georgia, United States
, Chicago, Illinois, United States
, Minneapolis, Minnesota, United States
, Billings, Montana, United States
, Albany, New York, United States
, East Setauket, New York, United States
, Kettering, Ohio, United States
, Greenville, South Carolina, United States
, Nashville, Tennessee, United States
, Dallas, Texas, United States
, Ft. Worth, Texas, United States
, Tyler, Texas, United States
, Spokane, Washington, United States
, Marshfield, Wisconsin, United States
, Belo Horizonte, , Brazil
, Porto Alegre, , Brazil
, Rio de Janeiro, , Brazil
, Calgary, Alberta, Canada
, Vancouver, British Columbia, Canada
, Winnipeg, Manitoba, Canada
, London, Ontario, Canada
, Montreal, Quebec, Canada
, Santiago, , Chile
, Zagreb, , Croatia
, Avignon, , France
, Orleans, , France
, Paris, , France
, Saint-Brieuc, , France
, Saint-Gregoire, , France
, Lima, , Peru
, Bucharest, , Romania
, Cluj-Napoca, , Romania
, Arkhangelsk, , Russian Federation
, Chelyabinsk, , Russian Federation
, Moscow, , Russian Federation