CapTemY90 for Grade 2 NET Liver Metastases

Last updated: October 30, 2024
Sponsor: Abramson Cancer Center at Penn Medicine
Overall Status: Active - Recruiting

Phase

2

Condition

Digestive System Neoplasms

Carcinoid Syndrome And Carcinoid Tumours

Neoplasms

Treatment

Temozolomide Oral Product

Capecitabine Oral Product

transarterial radioembolization

Clinical Study ID

NCT04339036
UPCC 04219
04219
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with confirmed diagnosis of histologic grade 2 neuroendocrine tumor withunresectable liver metastases (primary tumor or other extrahepatic disease may bepresent)

  • Patients with at least one measurable liver metastases, with size > 1cm (RECISTcriteria)

  • Patients with liver dominant disease defined as ≥50% tumor body burden confined tothe 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 ≤5times 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 consentdocument.

  • Women of child bearing potential and fertile men are required to use effectivecontraception (negative urine or serum βHCG for women of child-bearing age)

Exclusion

Exclusion Criteria:

  • Contraindications to capecitibine or temozolomide

  • Contraindicated for both contrast-enhanced MRI and CT

  • Patients previously treated with transarterial embolization (with or withoutchemotherapy) 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 ofextra-hepatic structures

  • Subjects consenting to the trial who fail their simulation angiography will beremoved from the study and replaced.

  • Patients may not be receiving any other investigational agents.

  • Absolute contraindication to intravenous iodinated contrast (Hx of significantprevious contrast reaction, not mitigated by appropriate pre-medication).

  • Choledochoenteric anastomosis, transpapillary stent or sphincterotomy of duodenalpapilla;

  • Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliancewith study requirements.

  • Pregnant and lactating women are ineligible

Study Design

Total Participants: 50
Treatment Group(s): 3
Primary Treatment: Temozolomide Oral Product
Phase: 2
Study Start date:
October 07, 2021
Estimated Completion Date:
May 01, 2026

Study Description

Patients with liver-dominant Grade 2 NET metastases from any primary will start CapTem and undergo simulation angiography for radioembolization planning during the first cycle. If they tolerate CapTem and are not excluded from radioembolization, then TARE will be performed on Day 7 of Cycle 2, with additional TARE of Day 7 of cycle 3 or 4 as needed to treat the entire tumor burden. Patients will remain on CapTem until progression or intolerance.

Primary outcome measure is hepatic progression-free survival.

Connect with a study center

  • CARTI Cancer Center

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • UC San Diego

    La Jolla, California 92037
    United States

    Active - Recruiting

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York 14203
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19103
    United States

    Active - Recruiting

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