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Liposomal Doxorubicin in Treating Patients With Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
pegylated liposomal doxorubicin hydrochloride
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring recurrent prostate cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed hormone refractory prostate cancer Castrate serum testosterone levels less than 30 mg/dL occurring at least 4 weeks since prior flutamide or at least 6 weeks since prior bicalutamide Measurable or evaluable progressive disease Rising PSA involving two determinations (one at least 20 ng/mL if PSA is sole criterion) at least two weeks apart OR Increasing measurable or evaluable disease OR New metastasis PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL No hepatic insufficiency Renal: Creatinine no greater than 2.0 mg/dL No renal failure Cardiovascular: Cardiac ejection fraction at least 50% by radionuclide ventriculogram No myocardial infarction within the past year No active angina No congestive heart failure No arrhythmias requiring medication Other: No active peptic ulcers No uncontrolled infection or other serious medical condition that would prevent compliance with chemotherapy No uncontrolled diabetes No spinal cord compression or carcinomatous meningitis PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: No concurrent corticosteroid therapy Concurrent gonadotropin-releasing hormone analogue allowed Radiotherapy: At least 2 months since prior radiotherapy (not to a measurable lesion) Concurrent palliative radiotherapy allowed Surgery: Not specified

Sites / Locations

  • Ireland Cancer Center at University Hospitals Case Medical Center

Outcomes

Primary Outcome Measures

Effectiveness of liposomal doxorubicin in treating patients with prostate cancer that has not responded to hormone therapy.

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
August 13, 2010
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004014
Brief Title
Liposomal Doxorubicin in Treating Patients With Prostate Cancer
Official Title
Liposome-Encapsulated Doxorubicin (LED) in Hormone Refractory Prostate Carcinoma, Phase II
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
April 1999 (undefined)
Primary Completion Date
January 2000 (Actual)
Study Completion Date
November 2001 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
pegylated liposomal doxorubicin hydrochloride
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed hormone refractory prostate cancer Castrate serum testosterone levels less than 30 mg/dL occurring at least 4 weeks since prior flutamide or at least 6 weeks since prior bicalutamide Measurable or evaluable progressive disease Rising PSA involving two determinations (one at least 20 ng/mL if PSA is sole criterion) at least two weeks apart OR Increasing measurable or evaluable disease OR New metastasis PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL No hepatic insufficiency Renal: Creatinine no greater than 2.0 mg/dL No renal failure Cardiovascular: Cardiac ejection fraction at least 50% by radionuclide ventriculogram No myocardial infarction within the past year No active angina No congestive heart failure No arrhythmias requiring medication Other: No active peptic ulcers No uncontrolled infection or other serious medical condition that would prevent compliance with chemotherapy No uncontrolled diabetes No spinal cord compression or carcinomatous meningitis PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: No concurrent corticosteroid therapy Concurrent gonadotropin-releasing hormone analogue allowed Radiotherapy: At least 2 months since prior radiotherapy (not to a measurable lesion) Concurrent palliative radiotherapy allowed Surgery: Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cindy Connell, MD, PhD
Organizational Affiliation
Ireland Cancer Center at University Hospitals/Case Medical Center, Case Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Ireland Cancer Center at University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States

12. IPD Sharing Statement

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Liposomal Doxorubicin in Treating Patients With Prostate Cancer

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