Metastatic Cancer Clinical Trial
Official title:
Treatment of Patients With Hepatic Neuroendocrine Metastases Using Drug-Eluting Bead Embolization
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Infusing doxorubicin beads into the liver, and blocking blood flow to the tumor, may keep
doxorubicin near the tumor and kill more tumor cells.
PURPOSE: This clinical trial is studying the side effects of doxorubicin beads and to see
how well they work in treating patients with unresectable liver metastases from
neuroendocrine tumors.
OBJECTIVES:
Primary
- To gather preliminary data and determine the feasibility of a randomized study of
patients with unresectable hepatic neuroendocrine metastases using PVA microporous
hydrospheres/doxorubicin hydrochloride.
OUTLINE: A catheter is placed into the right or left hepatic artery. Patients with unifocal
tumors will have the catheter or microcatheter placed more selectively into the 2nd or 3rd
order branch off the right or left hepatic artery in closer proximity to the tumor. PVA
microporous hydrospheres/doxorubicin hydrochloride mixture is injected into the delivery
area.
Patients with less than 75% necrosis at 1 month undergo a second (and possibly a third a
month later) chemoembolization.
After completion of study therapy, patients are followed at 1 month, every 2 months for 1
year, and then every 3 months for 1 year.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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