A Dose Escalation, Pharmacokinetics, and Safety Study of Doxorubicin Encapsulated in Temperature Sensitive Liposomes Released Through Microwave Therapy in the Treatment of Prostate Cancer
40 Years
N/A
Male
Prostate Cancer
Trial Information
A Dose Escalation, Pharmacokinetics, and Safety Study of Doxorubicin Encapsulated in Temperature Sensitive Liposomes Released Through Microwave Therapy in the Treatment of Prostate Cancer
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Catherine Van Doren, RN
Investigator Role:
Study Chair
Investigator Affiliation:
Celsion
Authority:
United States: Federal Government
Study ID:
CELSION-10302101
NCT ID:
NCT00061867
Start Date:
March 2003
Completion Date:
August 2005
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage III prostate cancer
- stage IV prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Regional Urology, L.L.C. | Shreveport, Louisiana 71101 |
| Grand Strand Urology LLP | Myrtle Beach, South Carolina 29572 |
