Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
completion around
Principal Investigator
by Zachary Berman, md (ucsd)

Description

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.

Official Title

UPCC 04219 Phase 2 Study of Capecitabine-Temozolomide(CapTem) With Yttrium-90 Radioembolization in the Treatment of Patients With Unresectable Metastatic Grade 2 Neuroendocrine Tumors

Details

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.

Keywords

Neuroendocrine Tumor Grade 2, Neuroendocrine Tumors, Neoplasms, Capecitabine, Temozolomide, Capecitabine Oral Product, Temozolomide Oral Product, transarterial radioembolization, Oral CapTem + Y90 Radioembolization

Eligibility

Locations

  • UC San Diego accepting new patients
    La Jolla California 92037 United States
  • Roswell Park Comprehensive Cancer Center accepting new patients
    Buffalo New York 14203 United States
  • University of Pennsylvania accepting new patients
    Philadelphia Pennsylvania 19103 United States

Lead Scientist at University of California Health

  • Zachary Berman, md (ucsd)
    Associate Clinical Professor, Radiology, Vc-health Sciences-schools. Authored (or co-authored) 24 research publications. Research interests: Interventional Oncology · Novel Embolization · Vascular Malformations

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Abramson Cancer Center at Penn Medicine
ID
NCT04339036
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 50 study participants
Last Updated