Liposomal Doxorubicin and Thermal Therapy in Treating Patients With Prostate Cancer

Study Overview
=================
Brief 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.

Detailed 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.

Official Title
-----------------
A Dose Escalation, Pharmacokinetics, and Safety Study of Doxorubicin Encapsulated in Temperature Sensitive Liposomes Released Through Microwave Therapy in the Treatment of Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: pegylated liposomal doxorubicin hydrochloride
* Procedure: hyperthermia treatment


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: pegylated liposomal doxorubicin hydrochloride|nan|
|Procedure: hyperthermia treatment|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adenocarcinoma of the prostate, stage III prostate cancer, stage IV prostate cancer