CapTemY90 for Grade 2/3 NET Liver Metastases

Korábbi kezelés

• Contraindications to capecitibine or temozolomide
• Patients previously treated with transarterial embolization (with or without chemotherapy) or with radioembolization (Y-90 microspheres)
• Patients may not be receiving any other investigational agents.
• Absolute contraindication to intravenous iodinated contrast (Hx of significant previous contrast reaction, not mitigated by appropriate pre-medication).

Más betegség

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Egyéb

• Contraindicated for both contrast-enhanced MRI and CT
• Contraindication for radioembolization procedures:
• excessive hepatopulmonary shunt as determined by the investigator
• inability to deliver Y90 microspheres without risk of non-target embolization of extra-hepatic structures
• Subjects consenting to the trial who fail their simulation angiography will be removed from the study and replaced.
• Choledochoenteric anastomosis, transpapillary stent or sphincterotomy of duodenal papilla;
• Pregnant and lactating women are ineligible

• Patients with confirmed diagnosis of histologic grade 2 or 3 well differentiated neuroendocrine tumor with unresectable liver metastases (primary tumor or other extrahepatic disease may be present)
• Patients with at least one measurable liver metastases, with size > 1cm (RECIST criteria)
• Patients with liver dominant disease defined as ≥50% tumor body burden confined to the liver
• Liver tumor burden does not exceed 50% of the liver volume
• Patent main portal vein
• At least 4 weeks since last administration of last chemotherapy and /or radiotherapy
• Age >18 years.
• Life expectancy of greater than 6 months.
• ECOG performance status 0-2.
• Adequate liver function as measured by: Total bilirubin ≤ 2.0mg/dl, ALT, AST ≤5 times ULN, albumin ≥2.5g/dl.
• Patients must have adequate organ and marrow function as defined below:
• platelets >100,000/mcL (may be corrected by transfusion)
• serum creatinine < 2.0 mg/dl
• INR <1.6, (may be corrected by transfusion)
• Ability to understand and the willingness to sign a written informed consent document.
• Women of child bearing potential and fertile men are required to use effective contraception (negative urine or serum βHCG for women of child-bearing age)