Liposomal Doxorubicin in Treating Patients With Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00004014
First received: November 1, 1999
Last updated: August 13, 2010
Last verified: August 2010
  Purpose

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 Intervention Phase
Prostate Cancer
Drug: pegylated liposomal doxorubicin hydrochloride
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Liposome-Encapsulated Doxorubicin (LED) in Hormone Refractory Prostate Carcinoma, Phase II

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: April 1999
Study Completion Date: November 2001
Primary Completion Date: January 2000 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004014

Locations
United States, Ohio
Ireland Cancer Center at University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: Cindy Connell, MD, PhD Ireland Cancer Center at University Hospitals/Case Medical Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Cindy Connell, MD, PhD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00004014     History of Changes
Other Study ID Numbers: NEO1898, P30CA043703, CWRU-NEO-1898, NEOPHARM-LED-P2, NCI-G99-1558
Study First Received: November 1, 1999
Last Updated: August 13, 2010
Health Authority: United States: Federal Government

Keywords provided by Case Comprehensive Cancer Center:
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014