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Alkylating agents

CapTem + Y90 for Neuroendocrine Cancer (CapTemY90 Trial)

Phase 2
Recruiting
Led By Michael Soulen
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Liver tumor burden does not exceed 50% of the liver volume
Patients with confirmed diagnosis of histologic grade 2 neuroendocrine tumor with unresectable liver metastases (primary tumor or other extrahepatic disease may be present)
Must not have
Contraindications to capecitabine or temozolomide
Absolute contraindication to intravenous iodinated contrast (Hx of significant previous contrast reaction, not mitigated by appropriate pre-medication)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years. from time of initiation of study therapy until subject comes off of study, or study closes
Awards & highlights

Summary

This trial is testing if a combination of two treatments is more effective than either treatment alone in preventing the progression of liver metastases in patients with neuroendocrine tumors.

Who is the study for?
Adults over 18 with Grade 2 neuroendocrine tumors and liver metastases that can't be removed by surgery. They should have a life expectancy of more than 6 months, stable health, and not have had chemotherapy or radiotherapy in the last 4 weeks. Liver function must be within certain limits, and they need to use effective contraception if capable of childbearing.Check my eligibility
What is being tested?
The trial is testing how well patients with specific liver tumors respond to a combination therapy using Capecitabine, Temozolomide (oral medications), and Y90 radioembolization compared to previous treatments. It's a Phase 2 study focusing on whether this mix can safely improve disease control.See study design
What are the potential side effects?
Possible side effects include those common to chemotherapy like nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems. Radioembolization may cause abdominal pain or fever. Specific risks will depend on individual patient factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Less than half of my liver is affected by cancer.
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I have a grade 2 neuroendocrine tumor with liver metastases that cannot be surgically removed.
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My liver is working well, based on recent tests.
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My blood platelets, kidney function, and blood clotting levels are within the required ranges.
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My main portal vein is open and unblocked.
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I am older than 18 years.
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Half or more of my cancer is in my liver.
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I can take care of myself and am up and about more than half of the day.
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I have a liver tumor larger than 1cm that can be measured.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot take capecitabine or temozolomide due to adverse reactions.
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I cannot have IV contrast due to a severe past reaction.
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I have had surgery or a procedure to treat bile duct blockage.
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I have had treatment with transarterial embolization or radioembolization.
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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years. from time of initiation of study therapy until subject comes off of study, or study closes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years. from time of initiation of study therapy until subject comes off of study, or study closes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Intra-hepatic progression-free survival
Secondary outcome measures
Change in CgA over time
Intra-hepatic tumor responses by EASL
Intra-hepatic tumor responses by RECIST
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Oral CapTem + Y90 RadioembolizationExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine Oral Product
2011
Completed Phase 3
~70

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,027 Previous Clinical Trials
42,885,661 Total Patients Enrolled
2 Trials studying Neuroendocrine Tumors
1,161 Patients Enrolled for Neuroendocrine Tumors
Abramson Cancer Center at Penn MedicineLead Sponsor
396 Previous Clinical Trials
147,916 Total Patients Enrolled
2 Trials studying Neuroendocrine Tumors
174 Patients Enrolled for Neuroendocrine Tumors
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
105,871 Total Patients Enrolled
2 Trials studying Neuroendocrine Tumors
217 Patients Enrolled for Neuroendocrine Tumors

Media Library

Capecitabine Oral Product (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04339036 — Phase 2
Neuroendocrine Tumors Research Study Groups: Oral CapTem + Y90 Radioembolization
Neuroendocrine Tumors Clinical Trial 2023: Capecitabine Oral Product Highlights & Side Effects. Trial Name: NCT04339036 — Phase 2
Capecitabine Oral Product (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04339036 — Phase 2
~11 spots leftby May 2025
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