Metastatic Cancer Clinical Trial
Official title:
A Phase I Dose Escalation Study Of Heat Activated Liposome Delivery Of Doxorubicin And Radiofrequency Ablation Of Primary And Metastatic Tumors Of The Liver
RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways
to stop tumor cells from dividing so they stop growing or die. Radiofrequency ablation uses
high-frequency electric current to kill tumor cells. Combining radiofrequency ablation with
liposomal doxorubicin may increase the effectiveness of the drug and kill more tumor cells.
PURPOSE: This phase I trial is studying the best dose of liposomal doxorubicin when given
with radiofrequency ablation in treating patients with primary or metastatic liver tumors.
OBJECTIVES:
- Determine the maximum tolerated dose of heat activated doxorubicin HCl liposome when
combined with radiofrequency ablation in patients with primary or metastatic tumors of
the liver.
- Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
OUTLINE: This is a dose-escalation study of heat activated doxorubicin HCl liposome.
Patients receive doxorubicin HCl liposome IV over 30 minutes. Approximately 15 minutes after
the beginning of the doxorubicin HCl liposome infusion, patients undergo radiofrequency
ablation with needles inserted into the tumor(s) and heated to the target temperature for
approximately 12-60 minutes.
Cohorts of 3-6 patients receive escalating doses of heat activated doxorubicin HCl liposome
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At
least 6 patients are treated at the MTD.
Patients are followed at 28 days, every 3 months for 1 year, and then every 6 months for 2
years.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study within 2 years.
;
Primary Purpose: Treatment
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