NCT00730483

Doxorubicin Beads in Treating Patients With Unresectable Liver Metastases From Neuroendocrine Tumors

Treatment of Patients With Hepatic Neuroendocrine Metastases Using Drug-Eluting Bead Embolization

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. Polyvinyl alcohol (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.

Conditions

• Gastrointestinal Carcinoid Tumor
• Islet Cell Tumor
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	PVA microporous hydrospheres/doxorubicin hydrochloride

Timeline

• Start date: 2009-02-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2008-08-08
• Last updated: 2017-08-25
• Results posted: 2017-08-25

Locations

1 site across 1 country: United States