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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years. from time of initiation of study therapy until subject comes off of study, or study closes

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Intra-hepatic progression-free survival

Secondary study objectives

Change in CgA over time

Intra-hepatic tumor responses by EASL

Intra-hepatic tumor responses by RECIST

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 14Eligibility criteria met