Liposomal Doxorubicin in Treating Patients With Prostate Cancer
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.
|Prostate Cancer||Drug: pegylated liposomal doxorubicin hydrochloride||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Liposome-Encapsulated Doxorubicin (LED) in Hormone Refractory Prostate Carcinoma, Phase II|
- Effectiveness of liposomal doxorubicin in treating patients with prostate cancer that has not responded to hormone therapy. [ Time Frame: 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. ]
|Study Start Date:||April 1999|
|Study Completion Date:||November 2001|
|Primary Completion Date:||January 2000 (Final data collection date for primary outcome measure)|
Drug: pegylated liposomal doxorubicin hydrochloride
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004014
|United States, Ohio|
|Ireland Cancer Center at University Hospitals Case Medical Center|
|Cleveland, Ohio, United States, 44106-5065|
|Study Chair:||Cindy Connell, MD, PhD||Ireland Cancer Center at University Hospitals/Case Medical Center, Case Comprehensive Cancer Center|