NCT00004014

Liposomal Doxorubicin in Treating Patients With Prostate Cancer

Liposome-Encapsulated Doxorubicin (LED) in Hormone Refractory Prostate Carcinoma, Phase II

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating patients with prostate cancer that has not responded to hormone therapy.

Detailed description

OBJECTIVES: I. Estimate the objective response rate of patients with hormone refractory prostate cancer treated with doxorubicin HCl liposome. II. Determine the toxic effects (including any cumulative cardiotoxicity) of this regimen in these patients. III. Assess the effect of this regimen on pain and quality of life of these patients. OUTLINE: Patients receive doxorubicin HCl liposome IV over 45 minutes every 3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then every 9 weeks thereafter. Patients are followed every 3 months. PROJECTED ACCRUAL: Approximately 50 evaluable patients will be accrued for this study.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	pegylated liposomal doxorubicin hydrochloride	Doxorubicin HCl liposome IV over 45 minutes every 3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then every 9 weeks thereafter.

Timeline

• Start date: 1999-04-01
• Primary completion: 2000-01-01
• Completion: 2001-11-01
• First posted: 2004-09-14
• Last updated: 2010-08-16

Locations

1 site across 1 country: United States