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

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:
• •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:
• •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