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Liposome-Encapsulated Doxorubicin (LED) in Hormone Refractory Prostate Carcinoma, Phase II


Phase 2
N/A
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome 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.

Safety Issue:

No

Principal Investigator

Cindy Connell, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Ireland Cancer Center at University Hospitals/Case Medical Center, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

NEO1898

NCT ID:

NCT00004014

Start Date:

April 1999

Completion Date:

November 2001

Related Keywords:

  • Prostate Cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms

Name

Location

Ireland Cancer Center at University Hospitals Case Medical CenterCleveland, Ohio  44106-5065