UPCC 04219 Phase 2 Study of Capecitabine-Temozolomide(CapTem) With Yttrium-90 Radioembolization in the Treatment of Patients With Unresectable Metastatic Grade 2/3 Neuroendocrine Tumors
This is a Phase 2 evaluation of hepatic-progression free survival among patients with Grade 2 liver-dominant NET metastases undergoing combination therapy with CapTem and Y90 radioembolization.The hypothesis is to confirm safety and to assess if disease control is improved relative to expectation from either therapy alone. A Grade 3 arm was added in 2025.
• 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)