Liposomal Doxorubicin and Thermal Therapy in Treating Patients With Prostate Cancer - Full Text View

Sponsor:	Celsion
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00061867

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Drug: pegylated liposomal doxorubicin hydrochloride Procedure: hyperthermia treatment	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

March 2003

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.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061867

Locations

United States, Louisiana
Regional Urology, L.L.C.
Shreveport, Louisiana, United States, 71106
United States, South Carolina
Grand Strand Urology LLP
Myrtle Beach, South Carolina, United States, 29572

Sponsors and Collaborators

Celsion

Investigators

Study Chair:

Catherine Van Doren, RN

Celsion

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000301761, CELSION-10302101, RPCI-DS-0228
Study First Received:	June 5, 2003
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00061867 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the prostate
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male
Antineoplastic Agents
Therapeutic Uses

Urogenital Neoplasms
Antibiotics, Antineoplastic
Genital Diseases, Male
Prostatic Neoplasms
Pharmacologic Actions
Doxorubicin

ClinicalTrials.gov processed this record on February 08, 2010