A Dose Escalation, Pharmacokinetics, and Safety Study of Doxorubicin Encapsulated in Temperature Sensitive Liposomes Released Through Microwave Therapy in the Treatment of Prostate Cancer
- 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
- 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.
Masking: Open Label, Primary Purpose: Treatment
Catherine Van Doren, RN
United States: Federal Government
|Regional Urology, L.L.C.||Shreveport, Louisiana 71101|
|Grand Strand Urology LLP||Myrtle Beach, South Carolina 29572|