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Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00730483 |
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.
Condition | Intervention |
Gastrointestinal Carcinoid Tumor Islet Cell Tumor Metastatic Cancer |
Drug: PVA microporous hydrospheres/doxorubicin hydrochloride |
MedlinePlus related topics: | Cancer Carcinoid Tumors |
Drug Information available for: | Doxorubicin Doxorubicin hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Treatment of Patients With Hepatic Neuroendocrine Metastases Using Drug-Eluting Bead Embolization |
Estimated Enrollment: | 30 |
Study Start Date: | September 2008 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Inclusion criteria:
Diagnosis of hepatic neuroendocrine metastases not suitable for radical therapies (e.g., resection or liver transplantation)
Predominant to the liver disease, but extrahepatic disease is not an exclusion
Exclusion criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Must have preserved liver function (Child-Pugh class A-B) without significant liver decompensation
No advanced liver disease (e.g., Child-Pugh C class or active gastrointestinal bleeding, encephalopathy, or ascites [trace ascites is acceptable]), meeting the following criteria:
Exclusion criteria:
Any contraindication for hepatic embolization procedures, including any of the following:
PRIOR CONCURRENT THERAPY:
Exclusion criteria:
Use of PVA microporous hydrospheres/doxorubicin hydrochloride in the following applications:
Sidney Kimmel Comprehensive Cancer Center |
National Cancer Institute (NCI) |
Principal Investigator: | Jeffrey F. Geschwind, MD | Sidney Kimmel Comprehensive Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Responsible Party: | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Jeffrey F. Geschwind ) |
Study ID Numbers: | CDR0000601054, JHOC-J7039, JHOC-NA_000010736, JHOC-SKCCC-J7039 |
First Received: | August 7, 2008 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00730483 |
Health Authority: | Unspecified |
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