CapTemY90 for Grade 2/3 NET Liver Metastases

Part of paid clinical trials in La Jolla, California.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT04339036
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Capecitabine Oral Product — DRUG
    Capecitabine 750 mg/m2 twice daily orally for 14 days
  • Temozolomide Oral Product — DRUG
    temozolomide 200 mg/m2 orally on Days 10-14, with 14 days between cycles
  • transarterial radioembolization — COMBINATION_PRODUCT
    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.

Study Details

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.

Key Dates

Start date
Oct 7, 2021
Status verified
Jun 2026
Primary completion
Jul 1, 2028
Completion
Jul 1, 2028

Study Design

Enrollment
70 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Oral CapTem + Y90 Radioembolization
    Capecitabine 750 mg/m2 twice daily orally for 14 days and temozolomide 200 mg/m2 orally on Days 10-14, with 14 days between cycles, to be continued until 1) disease progression or 2) intolerable toxicities. 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.

Primary Outcome Measure

Intra-hepatic progression-free survival [ Time Frame: 2 years. Time from initiation of study therapy until first documented intra-hepatic disease progression, death due to any cause or last scan date that documented intra-hepatic progression-free status. ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
UC San DiegoLa JollaCalifornia92037
Osita Ofuani, BS
[email protected]
Michaela Doering, BS
[email protected]
Zachary Berman, md (PRINCIPAL_INVESTIGATOR)
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiamiFlorida33136
Lindsay Thornton, MD
[email protected]
305-243-5509
Lindsay Thornton, MD (PRINCIPAL_INVESTIGATOR)
Roswell Park Comprehensive Cancer CenterBuffaloNew York14203
Deepon Paul Singh
mailto:[email protected]
1-800-767-9355
Renuka Iyer, MD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19103
Abashai Woodard
[email protected]
215-746-7050
Michael Soulen, MD (PRINCIPAL_INVESTIGATOR)

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