drugset / Trial / NCT00124566
Study of Irofulven in Patients With Hormone-refractory Prostate Cancer
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2004-06
- Primary completion
- 2006-01
- Completion
- 2009-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Comparator | Mitoxantrone | Small molecule | 12 mg/m2 | Intravenous |
| Subject | irofulven | Small molecule | 0.4 mg/kg | Intravenous |
| Subject | irofulven | Small molecule | 0.45 mg/kg | Intravenous |
| Background | Prednisone | Other / unclassified | 10 mg | Oral |