NCT00730483

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2008

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

August 25, 2017

Completed
Last Updated

August 25, 2017

Status Verified

July 1, 2017

Enrollment Period

5.3 years

First QC Date

August 7, 2008

Results QC Date

April 19, 2017

Last Update Submit

July 24, 2017

Conditions

Gastrointestinal Carcinoid TumorIslet Cell TumorMetastatic Cancer

Keywords

liver metastasesmetastatic gastrointestinal carcinoid tumorregional gastrointestinal carcinoid tumorislet cell carcinomagastrinomainsulinomaglucagonomapancreatic polypeptide tumorsomatostatinoma

Outcome Measures

Primary Outcomes (1)

  • Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE

    Safety was assessed at each DEB-TACE procedure and at every follow-up thereafter according to National Cancer Institute Common Toxicity Criteria (CTCAE) v3.0. The study was prematurely terminated due to high incidence of biloma and liver abscess. Safety data below is based off of 13 patients enrolled on protocol at 1 month post initial treatment.

    1 month after initial DEB-TACE treatment

Secondary Outcomes (4)

  • Tumor Response (Efficacy) - by Response Evaluation Criteria in Solid Tumors (RECIST) and the European Association for the Study of the Liver (EASL) Criteria

    12 months

  • Survival

    overall survival

  • Biochemical Response - Time to Progression

    Time to progression, 12 months

  • Symptomatic Response by Assessing Symptom Severity in Patients

    Duration of study participation, average of 12 months

Study Arms (1)

DEB-TACE

EXPERIMENTAL

PVA microporous hydrospheres loaded with doxorubicin hydrochloride used for the treatment of unresectable liver metastases from neuroendocrine tumors.

Drug: PVA microporous hydrospheres/doxorubicin hydrochloride

Interventions

PVA microporous hydrospheres/doxorubicin hydrochlorideDRUG
DEB-TACE

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of hepatic neuroendocrine metastases not suitable for radical therapies (e.g., resection or liver transplantation)
  • Histologically proven neuroendocrine tumor
  • Tumors are hypervascular based on visual estimation by investigator
  • No predominant extrahepatic liver disease
  • No significant life-threatening extrahepatic disease, in the judgment of the physician
  • Recent-interval progression of hepatic liver metastases
  • No diffuse hepatic neuroendocrine metastases defined as massive ill-defined tumor involvement measuring \> 90% tumor burden

You may not qualify if:

  • Clinically evident ascites (a radiographic finding of trace ascites on imaging is acceptable)
  • Complete occlusion of the entire portal venous system
  • Evidence of cirrhosis or portal hypertension
  • Vascular resistance peripheral to the feeding arteries precluding passage of PVA microporous hydrospheres/doxorubicin hydrochloride
  • PATIENT CHARACTERISTICS:
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • 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:
  • Bilirubin \> 3 mg/dL
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase \> 5 times upper limit of normal
  • Serum creatinine \> 2.0 mg/dL
  • Albumin ≤ 2.0 g/dL
  • No vascular anatomy or blood that precludes catheter placement or emboli injection
  • No presence of arteries supplying the lesion not large enough to accept PVA microporous hydrospheres/doxorubicin hydrochloride
  • No collateral vessel pathways potentially endangering normal territories during embolization
  • +25 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Related Publications (1)

  • Bhagat N, Reyes DK, Lin M, Kamel I, Pawlik TM, Frangakis C, Geschwind JF. Phase II study of chemoembolization with drug-eluting beads in patients with hepatic neuroendocrine metastases: high incidence of biliary injury. Cardiovasc Intervent Radiol. 2013 Apr;36(2):449-59. doi: 10.1007/s00270-012-0424-y. Epub 2012 Jun 22.

    PMID: 22722717DERIVED

MeSH Terms

Conditions

Adenoma, Islet CellNeoplasm MetastasisCarcinoma, Islet CellGastrinomaInsulinomaGlucagonomaSomatostatinoma

Interventions

Doxorubicin

Condition Hierarchy (Ancestors)

AdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsPancreatic NeoplasmsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsAdenocarcinomaCarcinomaCarcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and Embryonal

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Results Point of Contact

Title
Jean-Francois Geschwind, MD
Organization
Yale University
jeff.geschwind@yale.edu
203-785-5865

Study Officials

  • Jeffrey F. Geschwind, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Radiology and Oncology

Study Record Dates

First Submitted

August 7, 2008

First Posted

August 8, 2008

Study Start

February 1, 2009

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

August 25, 2017

Results First Posted

August 25, 2017

Record last verified: 2017-07

Locations

US(1)