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	Treatment or Intervention	Phase
Quality of Life recurrent prostate cancer	Drug: doxorubicin HCl liposome	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Criteria

PROTOCOL ENTRY 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

--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

--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

Ohio
      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States

Study chairs or principal investigators

Cindy Connell,  Study Chair,  Ireland Cancer Center   

Study ID Numbers:  CDR0000067231; CWRU-NEO-1898; NCI-G99-1558; NEOPHARM-LED-P2
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00004014
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08