NCT00124566

Study of Irofulven in Patients With Hormone-refractory Prostate Cancer

Three-Arm Randomized Phase II Clinical Study of Irofulven/Prednisone, Irofulven/Capecitabine/Prednisone or Mitoxantrone/Prednisone in Docetaxel-Pretreated Hormone-Refractory Prostate Cancer Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Irofulven	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.
DRUG	Prednisone	Subjects will also receive oral prednisone at a dose of 10 mg per day in the morning.
DRUG	Mitoxantrone	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.
DRUG	Capecitabine	Subjects will receive oral capecitabine at a dose of 1000 mg/m\^2 twice daily for 15 days every 28 days.
DRUG	Irofulven	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.

Timeline

• Start date: 2004-06-01
• Primary completion: 2006-01-01
• Completion: 2009-12-01
• First posted: 2005-07-28
• Last updated: 2016-01-18

Locations

50 sites across 9 countries: United States, Brazil, Canada, Chile, Croatia, France, Peru, Romania, Russia