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

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: Sidney Kimmel Comprehensive Cancer Center

Current Primary Outcome:

  • Tumor response (efficacy) [ Time Frame: Time to progression ]
  • Safety [ Time Frame: 30 days post study exit ]


Original Primary Outcome:

  • Tumor response (efficacy)
  • Safety


Current Secondary Outcome:

  • Survival [ Time Frame: overall survival ]
  • Biochemical response [ Time Frame: Time to progression ]
  • Symptomatic response [ Time Frame: Time to progression ]


Original Secondary Outcome:

  • Survival
  • Biochemical response
  • Symptomatic response


Information By: Sidney Kimmel Comprehensive Cancer Center

Dates:
Date Received: August 7, 2008
Date Started: February 2009
Date Completion: June 2015
Last Updated: October 1, 2014
Last Verified: October 2014