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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
135
Subjects will receive irofulven in a 30 minute intravenous (IV) infusion at a dose of 0.45 mg/kg on Days 1 and 8 every 3 weeks.
Subjects will also receive oral prednisone at a dose of 10 mg per day in the morning.
Subjects will receive mitoxantrone in an intravenous (IV) infusion (5 to 15 minutes) at a dose of 12 mg/m\^2 per day, once every 3 weeks.
Time to progression: RECIST (Response Evaluation Criteria in Solid Tumors) criteria
Time frame: Between randomization and study discontinuation or disease progression, whichever occurs later.
Time to progression: Prostate-specific antigen (PSA) evolution (Prostate-Specific Antigen Working Group Recommendations [PSAWGR criteria]).
Time frame: Between randomization and study discontinuation or disease progression, whichever occurs later.
Efficacy: Overall survival; objective response rate and PSA response rate according to RECIST and PSAWGR criteria, respectively.
Time frame: Between randomization and death.
Determine safety profile of each treatment arm: incidence and severity of adverse events (AEs), serious AEs, and laboratory abnormalities.
Time frame: Between randomization until a minimum of 30 days after last dose of study drug; treatment-related AEs will be followed until resolution.
Assess pain response in patients with significant pain at baseline using Tannock criteria and McGill-Melzack Pain Questionnaire.
Time frame: Seven days prior to randomization and prior to each new cycle of study drug administration.
Quality of life (QOL) as measured by the Prostate Cancer Specific Quality of Life Instrument (PROSQOLI).
Time frame: Between baseline and study drug discontinuation.
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Subjects will receive oral capecitabine at a dose of 1000 mg/m\^2 twice daily for 15 days every 28 days.
Subjects will receive irofulven in a 30 minute intravenous (IV) infusion at a dose of 0.4 mg/kg on Days 1 and 15 every 4 weeks.
Unnamed facility
Hot Springs, Arkansas, United States
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Jonesboro, Arkansas, United States
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Greenbrae, California, United States
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Colorado Springs, Colorado, United States
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Bonita Springs, Florida, United States
Unnamed facility
Bradenton, Florida, United States
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Cape Coral, Florida, United States
Unnamed facility
Fort Meyers, Florida, United States
Unnamed facility
Naples, Florida, United States
Unnamed facility
Port Charlotte, Florida, United States
...and 40 more locations