CapTemY90 for Grade 2 NET Liver Metastases

Launched by ABRAMSON CANCER CENTER AT PENN MEDICINE · Apr 7, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for patients with Grade 2 neuroendocrine tumors (NETs) that have spread to the liver. Specifically, the study is assessing how well a combination of two therapies, CapTem (which includes capecitabine and temozolomide) and Y90 radioembolization, can control the disease and help patients live longer without their cancer worsening. Researchers want to find out if this combination is safer and more effective than using either treatment on its own.

To be eligible for this trial, patients need to be at least 18 years old and have a confirmed diagnosis of Grade 2 neuroendocrine tumors with liver metastases that cannot be surgically removed. They should have measurable tumors in the liver, but the overall liver tumor burden must not be too high. Participants will be monitored closely throughout the trial, and they will need to meet specific health criteria to ensure their safety. This study is currently recruiting participants, so if you or someone you know fits these criteria and is interested, it could be a chance to access new treatment options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with confirmed diagnosis of histologic grade 2 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)
• Exclusion Criteria:
• • Contraindications to capecitibine or temozolomide
• • Contraindicated for both contrast-enhanced MRI and CT
• • Patients previously treated with transarterial embolization (with or without chemotherapy) or with radioembolization (Y-90 microspheres)
• * 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.
• • 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).
• • Choledochoenteric anastomosis, transpapillary stent or sphincterotomy of duodenal papilla;
• • 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.
• • Pregnant and lactating women are ineligible