Status:
TERMINATED
Doxorubicin Beads in Treating Patients With Unresectable Liver Metastases From Neuroendocrine Tumors
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Gastrointestinal Carcinoid Tumor
Islet Cell Tumor
Eligibility:
All Genders
18-120 years
Phase:
NA
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 doxorubici...
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 hydrosphere...
Eligibility Criteria
Inclusion
- 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 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)
- Renal failure
- Severe peripheral vascular disease precluding catheterization
- Any contraindication for doxorubicin hydrochloride administration (i.e., serum bilirubin \> 5 mg/dL or leukocyte count \< 1,500 cells/mm³)
- Allergy to contrast media
- Intolerant to occlusion procedures
- Presence of end arteries leading directly to cranial nerves
- Presence or likely onset of hemorrhage
- Presence of severe atheromatous disease
- PRIOR CONCURRENT THERAPY:
- Exclusion criteria:
- Prior anticancer therapy for hepatic neuroendocrine metastases, except previous surgical therapy
- Any continuing complication or prior cancer therapy that has not improved or resolved prior to 21 days before start of treatment, if the investigator determines that the continuing complication will compromise the safety of the patient after treatment with PVA microporous hydrospheres/doxorubicin hydrochloride
- Presence of patent extra-to-intracranial anastomoses or shunts
- Use of PVA microporous hydrospheres/doxorubicin hydrochloride in the following applications:
- Embolization of large-diameter arteriovenous shunts
- Pulmonary arterial vasculature
- Any vasculature where the use of PVA microporous hydrospheres/doxorubicin hydrochloride could pass directly into the internal carotid artery or the above-listed vessels
- Concurrent enrollment in another clinical study
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00730483
Start Date
February 1 2009
End Date
June 1 2014
Last Update
August 25 2017
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410