NCT00061867

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 2003

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 6, 2003

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
Last Updated

May 30, 2013

Status Verified

July 1, 2005

First QC Date

June 5, 2003

Last Update Submit

May 29, 2013

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostatestage III prostate cancerstage IV prostate cancer

Interventions

pegylated liposomal doxorubicin hydrochlorideDRUG
hyperthermia treatmentPROCEDURE

Eligibility Criteria

Age40 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Regional Urology, L.L.C.

Shreveport, Louisiana, 71106, United States

Location

Grand Strand Urology LLP

Myrtle Beach, South Carolina, 29572, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Diathermy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hyperthermia, InducedTherapeutics

Study Officials

  • Catherine Van Doren, RN

    Imunon

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 5, 2003

First Posted

June 6, 2003

Study Start

March 1, 2003

Study Completion

August 1, 2005

Last Updated

May 30, 2013

Record last verified: 2005-07

Locations

US(2)