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
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 or disease||Intervention/treatment||Phase|
|Gastrointestinal Carcinoid Tumor Islet Cell Tumor Metastatic Cancer||Drug: PVA microporous hydrospheres/doxorubicin hydrochloride||Not Applicable|
- 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. Polyvinyl alcohol (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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Patients With Hepatic Neuroendocrine Metastases Using Drug-Eluting Bead Embolization|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
PVA microporous hydrospheres loaded with doxorubicin hydrochloride used for the treatment of unresectable liver metastases from neuroendocrine tumors.
|Drug: PVA microporous hydrospheres/doxorubicin hydrochloride|
- Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE [ Time Frame: 1 month after initial DEB-TACE treatment ]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.
- 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 ]
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.
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.
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
- Survival [ Time Frame: overall survival ]Survival outcomes not assessed due to premature termination of study.
- Biochemical Response - Time to Progression [ Time Frame: Time to progression, 12 months ]Biochemical response not assessed due to premature termination of study.
- Symptomatic Response by Assessing Symptom Severity in Patients [ Time Frame: Duration of study participation, average of 12 months ]
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:
- - No symptoms - Patient completely asymptomatic
- - Mild symptoms - Patient with symptoms of diarrhea, flushing, or asthma up to 4 times weekly
- - Symptoms impact daily living - symptoms of diarrhea, flushing, or asthma up 5-7 weekly
- - Severe symptoms - multiple daily symptoms of diarrhea, flushing, or asthma; symptoms require significant reorganization of daily activities
- - Disabling symptoms - Patient disabled by multiple attacks and severe symptoms; unable to leave home or requires hospitalization
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00730483
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|Principal Investigator:||Jeffrey F. Geschwind, MD||Sidney Kimmel Comprehensive Cancer Center|