CapTemY90 for Grade 2/3 NET Liver Metastases
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
Abramson Cancer Center at Penn Medicine
70 participants
Oct 7, 2021
INTERVENTIONAL
Conditions
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. A Grade 3 arm was added in 2025.
Eligibility
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Interventions
Capecitabine 750 mg/m2 twice daily orally for 14 days
temozolomide 200 mg/m2 orally on Days 10-14, with 14 days between cycles
Trans-arterial radioembolization (TARE) on Day 7 of cycle 2 and, if needed for the other lobe, Day 7 of either cycle 3 or 4.
Locations(4)
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NCT04339036