Liposomal Doxorubicin in Treating Patients With Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00004014|
Recruitment Status : Completed
First Posted : September 14, 2004
Last Update Posted : August 16, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: pegylated liposomal doxorubicin hydrochloride||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Liposome-Encapsulated Doxorubicin (LED) in Hormone Refractory Prostate Carcinoma, Phase II|
|Study Start Date :||April 1999|
|Primary Completion Date :||January 2000|
|Study Completion Date :||November 2001|
Drug: pegylated liposomal doxorubicin hydrochloride
- 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|