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Trial record 3 of 10 for:    "Carcinoid Syndrome" | "Pancreatic Polypeptide"

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

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ClinicalTrials.gov Identifier: NCT00730483
Recruitment Status : Terminated (High incidence of biloma and liver abscess after TACE)
First Posted : August 8, 2008
Results First Posted : August 25, 2017
Last Update Posted : August 25, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jeff Geschwind, Yale University

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
Enrollment 13
Recruitment Details 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  
Arm/Group Title Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)
Hide Arm/Group Description 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.
Period Title: Overall Study
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
Arm/Group Title Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 13 participants
64
(47 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
4
  30.8%
Male
9
  69.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
 100.0%
1.Primary Outcome
Title Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Hide Description 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.
Time Frame 1 month after initial DEB-TACE treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: number of adverse events
Anemia 1
Lymphopenia 2
Hypotension 1
Edema 2
Increased INR 2
Fatigue 9
Fever 4
Night sweats 6
Alopecia 3
Dry skin 1
Ascites 1
Anorexia 5
Biloma 6
Constipation 1
Diarrhea 1
Nausea 1
Taste alteration 1
Hematoma 1
Increased ALT 5
Increased AST 5
Increased AP 8
Hyperbilirubinemia 1
Hypoalbuminemia 5
Liver abscess 1
Hyperglycemia 5
Hyponatremia 1
Neuropathy 1
Abdominal nonspecific pain 5
Right upper quadrant pain 6
Pain - other 1
Dyspnea 1
Dyspnea on exertion 1
2.Secondary Outcome
Title Tumor Response (Efficacy) - by Response Evaluation Criteria in Solid Tumors (RECIST) and the European Association for the Study of the Liver (EASL) Criteria
Hide Description

Study was terminated and full outcome not assessed. The results below are based on 13 patients at 1 month post DEB-TACE, 10 patients at 6 months, and 6 patients at 12 months.

RECIST:

Complete Response (CR): Disappearance of all targeted lesions Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of targeted lesions Progressive Disease (PD): At least 20% increase in the sum of LD of targeted lesions Stable Disease (SD): Cases that are not applicable for PD or PR.

EASL:

CR: Absence of any enhancement in target lesion PR: Greater than 50% decrease from baseline enhancement in target lesion PD: Greater than 25% increase in target lesion SD: All other cases

Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
13 patients were analyzed for 1 month post-treatment; 10 patients for 6 months post-treatment; and 6 patients at the 12 month post-treatment time point.
Arm/Group Title Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
RECIST 1 month post-TACE Number Analyzed 13 participants
Complete Response (CR)
0
   0.0%
Partial Response (PR)
0
   0.0%
Stable Disease (SD)
13
 100.0%
Progressive Disease
0
   0.0%
EASL 1 month post-TACE Number Analyzed 13 participants
Complete Response (CR)
0
   0.0%
Partial Response (PR)
8
  61.5%
Stable Disease (SD)
5
  38.5%
Progressive Disease
0
   0.0%
RECIST 6 months post-TACE Number Analyzed 10 participants
Complete Response (CR)
0
   0.0%
Partial Response (PR)
1
  10.0%
Stable Disease (SD)
8
  80.0%
Progressive Disease
1
  10.0%
EASL 6 months post-TACE Number Analyzed 10 participants
Complete Response (CR)
1
  10.0%
Partial Response (PR)
3
  30.0%
Stable Disease (SD)
6
  60.0%
Progressive Disease
0
   0.0%
RECIST 12 months post-TACE Number Analyzed 6 participants
Complete Response (CR)
0
   0.0%
Partial Response (PR)
1
  16.7%
Stable Disease (SD)
4
  66.7%
Progressive Disease
1
  16.7%
EASL 12 months post-TACE Number Analyzed 6 participants
Complete Response (CR)
2
  33.3%
Partial Response (PR)
1
  16.7%
Stable Disease (SD)
3
  50.0%
Progressive Disease
0
   0.0%
3.Secondary Outcome
Title Survival
Hide Description Survival outcomes not assessed due to premature termination of study.
Time Frame overall survival
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm
Hide Arm/Group Description:
PVA microporous hydrospheres/doxorubicin hydrochloride
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Biochemical Response - Time to Progression
Hide Description Biochemical response not assessed due to premature termination of study.
Time Frame Time to progression, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Symptomatic Response by Assessing Symptom Severity in Patients
Hide Description

Symptomatic response not assessed due to premature termination of study.

Scoring system for assessing symptom severity in patients with neuroendocrine/carcinoid syndrome was as follows:

  1. - No symptoms - Patient completely asymptomatic
  2. - Mild symptoms - Patient with symptoms of diarrhea, flushing, or asthma up to 4 times weekly
  3. - Symptoms impact daily living - symptoms of diarrhea, flushing, or asthma up 5-7 weekly
  4. - Severe symptoms - multiple daily symptoms of diarrhea, flushing, or asthma; symptoms require significant reorganization of daily activities
  5. - Disabling symptoms - Patient disabled by multiple attacks and severe symptoms; unable to leave home or requires hospitalization
Time Frame Duration of study participation, average of 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)
Hide Arm/Group Description 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.
All-Cause Mortality
Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)
Affected / at Risk (%)
Total   0/13 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)
Affected / at Risk (%) # Events
Total   7/13 (53.85%)    
Gastrointestinal disorders   
Liver biloma requiring drainage  1  4/13 (30.77%)  4
Gastric varices  1  1/13 (7.69%)  1
Hepatobiliary disorders   
Liver abscess  1  2/13 (15.38%)  2
Biliary stricture  1  1/13 (7.69%)  1
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)
Affected / at Risk (%) # Events
Total   13/13 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  3/13 (23.08%)  5
Leukocytopenia  1  1/13 (7.69%)  2
Cardiac disorders   
Bradycardia  1  1/13 (7.69%)  1
Palpitations  1  1/13 (7.69%)  1
Eye disorders   
Decreased vision  1  1/13 (7.69%)  1
Left eye swelling  1  1/13 (7.69%)  1
Gastrointestinal disorders   
Abdominal pain  1  9/13 (69.23%)  25
Bloating  1  2/13 (15.38%)  2
Constipation  1  6/13 (46.15%)  8
Diarrhea  1  3/13 (23.08%)  5
Dry mouth  1  1/13 (7.69%)  1
Flatulence  1  2/13 (15.38%)  2
Nausea  1  5/13 (38.46%)  8
Pancreatitis  1  1/13 (7.69%)  1
Vomiting  1  3/13 (23.08%)  5
General disorders   
Chills  1  1/13 (7.69%)  1
Pain - coccyx  1  1/13 (7.69%)  1
Edema - bilateral extremities  1  3/13 (23.08%)  3
Elevated alkaline phosphatase  1  11/13 (84.62%)  20
Fatigue  1  13/13 (100.00%)  27
Fever  1  6/13 (46.15%)  6
Pain - general  1  2/13 (15.38%)  2
Edema - hands  1  1/13 (7.69%)  2
Hypothermia  1  1/13 (7.69%)  1
Hepatobiliary disorders   
Cholecystitis  1  1/13 (7.69%)  1
Investigations   
Elevated ALT  1  10/13 (76.92%)  14
Elevated AST  1  11/13 (84.62%)  15
Elevated INR  1  5/13 (38.46%)  5
Hyperbilirubinemia  1  2/13 (15.38%)  4
Hyperglycemia  1  9/13 (69.23%)  12
Lymphopenia  1  4/13 (30.77%)  5
Thrombocytopenia  1  1/13 (7.69%)  1
Weight loss  1  1/13 (7.69%)  1
Metabolism and nutrition disorders   
Anorexia  1  6/13 (46.15%)  8
Hyperkalemia  1  1/13 (7.69%)  1
Hypernatremia  1  1/13 (7.69%)  1
Hypoalbuminemia  1  7/13 (53.85%)  9
Hypocalcemia  1  2/13 (15.38%)  2
Hypoglycemia  1  1/13 (7.69%)  1
Hyponatremia  1  1/13 (7.69%)  1
Musculoskeletal and connective tissue disorders   
Back pain  1  1/13 (7.69%)  1
Joint pain  1  1/13 (7.69%)  1
Leg pain  1  1/13 (7.69%)  1
Right flank pain  1  1/13 (7.69%)  1
Nervous system disorders   
Headache  1  1/13 (7.69%)  1
Neuropathy  1  1/13 (7.69%)  1
Dysgeusia  1  1/13 (7.69%)  1
Psychiatric disorders   
Anxiety  1  1/13 (7.69%)  1
Confusion  1  1/13 (7.69%)  1
Depression  1  1/13 (7.69%)  1
Insomnia  1  3/13 (23.08%)  3
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/13 (7.69%)  1
Dyspnea  1  2/13 (15.38%)  2
Hiccups  1  1/13 (7.69%)  1
Hoarseness  1  1/13 (7.69%)  1
Skin and subcutaneous tissue disorders   
Alopecia  1  3/13 (23.08%)  3
Dry skin  1  2/13 (15.38%)  2
Itching  1  1/13 (7.69%)  1
Night sweats  1  7/13 (53.85%)  12
Vascular disorders   
Flushing  1  1/13 (7.69%)  1
Hypertension  1  1/13 (7.69%)  1
Hematoma  1  1/13 (7.69%)  1
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jean-Francois Geschwind, MD
Organization: Yale University
Phone: 203-785-5865
EMail: jeff.geschwind@yale.edu
Layout table for additonal information
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