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

Not Applicable

Terminated

• Conditions: Gastrointestinal Carcinoid Tumor; Islet Cell Tumor; Metastatic Cancer
• Interventions: Drug: PVA microporous hydrospheres/doxorubicin hydrochloride

• Registration Number: NCT00730483
• Lead Sponsor: Yale University

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.

Detailed Description

OBJECTIVES:

Primary

* 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2008-08-07
• Study First Submitted QC: 2008-08-07
• Study First Posted: 2008-08-08
• Study Start: 2009-02
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Results First Submitted: 2017-04-19
• Status Verified: 2017-07
• Results First Submitted QC: 2017-07-24
• Last Update Submitted: 2017-07-24
• Results First Posted: 2017-08-25
• Last Update Posted: 2017-08-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DEB-TACE	PVA microporous hydrospheres/doxorubicin hydrochloride	PVA microporous hydrospheres loaded with doxorubicin hydrochloride used for the treatment of unresectable liver metastases from neuroendocrine tumors.

Primary Outcome Measures

Name	Time	Method
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE	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.

Secondary Outcome Measures

Name	Time	Method
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	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
Survival	overall survival	Survival outcomes not assessed due to premature termination of study.
Biochemical Response - Time to Progression	Time to progression, 12 months	Biochemical response not assessed due to premature termination of study.
Symptomatic Response by Assessing Symptom Severity in Patients	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: 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

Trial Locations

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States