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

This study has been terminated.
(High incidence of biloma and liver abscess after TACE)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00730483
First Posted: August 8, 2008
Last Update Posted: August 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jeff Geschwind, Yale University
Results First Submitted: April 19, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Gastrointestinal Carcinoid Tumor
Islet Cell Tumor
Metastatic Cancer
Intervention: Drug: PVA microporous hydrospheres/doxorubicin hydrochloride

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
13 patients were enrolled on this protocol at Johns Hopkins University. This study was terminated early due to high incidence of bilomas in patients receiving TACE treatment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE) Patients were treated with DEB-TACE loaded with doxorubicin up to four procedures in 6 months as indicated, for a maximum of six procedures during the course of 2 years. Follow-up clinical examinations, laboratory assessments, and imaging took place 1 month after each DEB-TACE treatment and then every 2 to 3 months for a period of 2 years. Each DEB-TACE procedure used a maximum of 100mg doxorubicin loaded onto 100-300um LC Beads.

Participant Flow:   Overall Study
    Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)
STARTED   13 
1 Month After First DEB-TACE   13 
6 Months After First DEB-TACE   10 
COMPLETED [1]   6 
NOT COMPLETED   7 
[1] 12 months after first DEB-TACE



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE) Patients were treated with DEB-TACE loaded with doxorubicin up to four procedures in 6 months as indicated, for a maximum of six procedures during the course of 2 years. Follow-up clinical examinations, laboratory assessments, and imaging took place 1 month after each DEB-TACE treatment and then every 2 to 3 months for a period of 2 years. Each DEB-TACE procedure used a maximum of 100mg doxorubicin loaded onto 100-300um LC Beads.

Baseline Measures
   Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE) 
Overall Participants Analyzed 
[Units: Participants]
 13 
Age 
[Units: Years]
Mean (Full Range)
 64 
 (47 to 80) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4  30.8% 
Male      9  69.2% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   13 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE   [ Time Frame: 1 month after initial DEB-TACE treatment ]

2.  Secondary:   Tumor Response (Efficacy) - by Response Evaluation Criteria in Solid Tumors (RECIST) and the European Association for the Study of the Liver (EASL) Criteria   [ Time Frame: 12 months ]

3.  Secondary:   Survival   [ Time Frame: overall survival ]

4.  Secondary:   Biochemical Response - Time to Progression   [ Time Frame: Time to progression, 12 months ]

5.  Secondary:   Symptomatic Response by Assessing Symptom Severity in Patients   [ Time Frame: Duration of study participation, average of 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jean-Francois Geschwind, MD
Organization: Yale University
phone: 203-785-5865
e-mail: jeff.geschwind@yale.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jeff Geschwind, Yale University
ClinicalTrials.gov Identifier: NCT00730483     History of Changes
Other Study ID Numbers: J0739 CDR0000601054
JHOC-J7039
JHOC-NA_000010736
JHOC-SKCCC-J7039
First Submitted: August 7, 2008
First Posted: August 8, 2008
Results First Submitted: April 19, 2017
Results First Posted: August 25, 2017
Last Update Posted: August 25, 2017