Doxorubicin Beads in Treating Patients With Unresectable Liver Metastases From Neuroendocrine Tumors (NCT00730483) | Clinical Trial Compass
TerminatedNot Applicable
Doxorubicin Beads in Treating Patients With Unresectable Liver Metastases From Neuroendocrine Tumors
Stopped: High incidence of biloma and liver abscess after TACE
United States13 participantsStarted 2009-02
Plain-language 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.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
Inclusion criteria:
* 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
* Predominant to the liver disease, but extrahepatic disease is not an exclusion
* 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
Exclusion criteria:
* 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:
Inclusion criteria:
* 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 a…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Timeframe: 1 month after initial DEB-TACE treatment