NCT00331344

Treating Patients With Metastatic Prostate Cancer Not Responding to Hormone and Chemotherapy

Phase I/II Trial of Epothilone Analog BMS-247550 (Ixabepilone), Mitoxantrone, and Prednisone in Hormone Refractory Prostate Cancer (HRPC) Patients Previously Treated With Chemotherapy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II trial is studying the side effects and best dose of ixabepilone and mitoxantrone hydrochloride when given together with prednisone and to see how well they work in treating patients with metastatic prostate cancer that did not respond to hormone therapy and chemotherapy. Drugs used in chemotherapy, such as ixabepilone, mitoxantrone hydrochloride, and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells

Detailed description

PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and dose-limiting toxicities of the combination of ixabepilone, mitoxantrone hydrochloride, and prednisone in patients with hormone-refractory metastatic prostate cancer that progressed during or after taxane-based chemotherapy. (Phase I) II. Assess the efficacy, as measured by reduction in prostate-specific antigen, of this regimen in these patients. (Phase II) SECONDARY OBJECTIVES: I. Evaluate the overall safety of this regimen as second-line chemotherapy in these patients. II. Evaluate the objective response rate in patients treated with this regimen. OUTLINE: This is a multicenter, phase I, open label, dose-escalation study of mitoxantrone hydrochloride and ixabepilone followed by a phase II study. PHASE I: Patients receive mitoxantrone hydrochloride intravenously (IV) over 30 minutes and ixabepilone IV over 3 hours on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of mitoxantrone hydrochloride and ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. PHASE II: Patients receive mitoxantrone hydrochloride and ixabepilone at the MTD determined in phase I and prednisone as in phase I. After completion of study treatment, patients are followed every 3 months.

Conditions

• Adenocarcinoma of the Prostate
• Recurrent Prostate Cancer
• Stage IV Prostate Cancer

Interventions

Type	Name	Description
DRUG	mitoxantrone hydrochloride	Given IV
DRUG	ixabepilone	Given IV
DRUG	prednisone	Given orally

Timeline

• Start date: 2006-04-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2006-05-31
• Last updated: 2017-10-31
• Results posted: 2017-10-31

Locations

2 sites across 1 country: United States