Prostate Cancer Clinical Trial
Liposomal Doxorubicin and Thermal Therapy in Treating Patients With Prostate Cancer
Summary
RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, use different ways to stop tumor cells from dividing so they stop growing or die. Microwave thermotherapy kills tumor cells by heating them to several degrees above body temperature. Combining liposomal doxorubicin with microwave thermotherapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of liposomal doxorubicin when given together with microwave thermotherapy in treating patients with prostate cancer.
Full Description
OBJECTIVES:
Determine the maximum tolerated dose of doxorubicin HCl liposome released through thermal microwave therapy in patients with adenocarcinoma of the prostate.
Determine the pharmacokinetics and biodistribution profile of this drug in these patients.
Determine the safety profile and dose-limiting toxicity of this drug in these patients.
Determine the clinical response in patients treated with this regimen.
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Patients receive doxorubicin HCl liposome IV over 30 minutes. Patients then undergo a 60-minute course of prostate thermotherapy. Treatment may repeat every 28-42 days for up to 6 courses, at the discretion of the physician.
Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 8, 15, 30, and 90 days.
PROJECTED ACCRUAL: Approximately 50 patients will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Rising prostate-specific antigen AND radiographic evidence of extraprostatic prostate cancer by bone scan, CT scan, prostascint scan, or MRI
PATIENT CHARACTERISTICS:
Age
40 and over
Performance status
Karnofsky 80-100%
Life expectancy
Not specified
Hematopoietic
WBC greater than 4,000/mm^3
Platelet count greater than 100,000/mm^3
Hemoglobin greater than 10.0 g/dL
Hepatic
Bilirubin normal
AST normal
Alkaline phosphatase normal
No acute or chronic liver disease
Renal
Creatinine less than 1.5 times upper limit of normal
Cardiovascular
Ejection fraction at least 50% by MUGA
EKG normal
No myocardial infarction or cerebral vascular accident within the past 6 months
No life threatening cardiac arrhythmias
No congestive heart failure
No cardiac pacemaker
No peripheral arterial disease with intermittent claudication or Leriches syndrome (i.e., claudication of the buttocks or perineum)
Other
Fertile patients must use effective barrier contraception during and for 3 months after study participation
No sperm donation during and for 3 months after study participation
Not febrile
No interest in future fertility or fathering children
No significantly decreased pain response
No severe urethral stricture
No protruding median lobe resulting in a "ball-valve" type of obstruction at the bladder neck
No major psychiatric illness that would prevent informed consent
No major psychiatric illness that required inpatient treatment within the past 3 months
No psychological, family, sociological, or geographic condition that would preclude study compliance
No allergy to eggs or egg products
No urinary or prostatic infection
No full urinary retention
No penile or urinary sphincter implant
No metallic implants in the pelvic or femoral area
No other serious medical illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
No concurrent live vaccines
Chemotherapy
No prior anthracycline
No concurrent streptozocin
Endocrine therapy
No concurrent hormonal therapy (except luteinizing hormone-releasing hormone analog)
No concurrent glucocorticoids administered at more than physiologic replacement doses (other than as an antiemetic)
Radiotherapy
Not specified
Surgery
More than 3 months since prior major surgery
Other
No prior therapy that resulted in permanent reduction of pain response (e.g., prior surgery, regional or local anesthetic)
No concurrent PC-SPES
No concurrent cyclosporine, phenobarbital, or phenytoin
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There are 2 Locations for this study
Shreveport Louisiana, 71106, United States
Myrtle Beach South Carolina, 29572, United States
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