Doxorubicin Beads in Treating Patients With Unresectable Liver Metastases From Neuroendocrine Tumors
Stopped early · Not applicable
Conditions studied: Gastrointestinal Carcinoid Tumor, Islet Cell Tumor, Metastatic Cancer
In brief
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.
Key facts
- Study ID
- NCT00730483
- Run by
- Yale University
- People needed
- 13
- Starts
- 2009-02-01
- Expected to finish
- 2014-06-01
- Last updated by the study team
- 2017-08-25
Who can join
Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase > 5 times upper limit of normal
- Serum creatinine > 2.0 mg/dL
- Albumin ≤ 2.0 g/dL
- No vascular anatomy or blood that precludes catheter placement or emboli injection
- No presence of arteries supplying the lesion not large enough to accept PVA microporous hydrospheres/doxorubicin hydrochloride
- No collateral vessel pathways potentially endangering normal territories during embolization
- No feeding arteries smaller than distal branches from which they emerge
- Not pregnant
- Exclusion criteria:
- See Disease Characteristics
- Another active primary tumor
- Any contraindication for hepatic embolization procedures, including any of the following:
- Porto-systemic shunt
- Hepatofugal blood flow
- Impaired clotting tests (i.e., platelet count < 50,000/mm³, international normalized ratio (INR) ≥ 1.8, or partial thromboplastin time (PTT) ≥ 39 seconds)
Where it is running
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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