Liposome-Encapsulated Doxorubicin (LED) in Hormone Refractory Prostate Carcinoma, Phase II
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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Effectiveness of liposomal doxorubicin in treating patients with prostate cancer that has not responded to hormone therapy.
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.
Cindy Connell, MD, PhD
Ireland Cancer Center at University Hospitals/Case Medical Center, Case Comprehensive Cancer Center
United States: Federal Government
|Ireland Cancer Center at University Hospitals Case Medical Center||Cleveland, Ohio 44106-5065|