Combination therapy for Grade 2 liver-dominant neuroendocrine tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 evaluation focuses on patients with Grade 2 liver-dominant neuroendocrine tumor metastases undergoing a combination therapy of Capecitabine and Temozolomide, followed by Y90 radioembolization. Patients will start with CapTem and undergo simulation angiography for planning radioembolization. If they tolerate the initial treatment, they will receive transarterial radioembolization to manage their tumor burden. The primary goal is to assess hepatic progression-free survival and confirm the safety of this combined approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with confirmed diagnosis of histologic grade 2 or 3 well differentiated neuroendocrine tumor with unresectable liver metastases (primary tumor or other extrahepatic disease may be present)
* Patients with at least one measurable liver metastases, with size \> 1cm (RECIST criteria)
* Patients with liver dominant disease defined as ≥50% tumor body burden confined to the liver
* Liver tumor burden does not exceed 50% of the liver volume
* Patent main portal vein
* At least 4 weeks since last administration of last chemotherapy and /or radiotherapy
* Age \>18 years.
* Life expectancy of greater than 6 months.
* ECOG performance status 0-2.
* Adequate liver function as measured by: Total bilirubin ≤ 2.0mg/dl, ALT, AST ≤5 times ULN, albumin ≥2.5g/dl.
* Patients must have adequate organ and marrow function as defined below:
* platelets \>100,000/mcL (may be corrected by transfusion)
* serum creatinine \< 2.0 mg/dl
* INR \<1.6, (may be corrected by transfusion)
* Ability to understand and the willingness to sign a written informed consent document.
* Women of child bearing potential and fertile men are required to use effective contraception (negative urine or serum βHCG for women of child-bearing age)

Exclusion Criteria:

* Contraindications to capecitibine or temozolomide
* Contraindicated for both contrast-enhanced MRI and CT
* Patients previously treated with transarterial embolization (with or without chemotherapy) or with radioembolization (Y-90 microspheres)
* Contraindication for radioembolization procedures:
* excessive hepatopulmonary shunt as determined by the investigator
* inability to deliver Y90 microspheres without risk of non-target embolization of extra-hepatic structures
* Subjects consenting to the trial who fail their simulation angiography will be removed from the study and replaced.
* Patients may not be receiving any other investigational agents.
* Absolute contraindication to intravenous iodinated contrast (Hx of significant previous contrast reaction, not mitigated by appropriate pre-medication).
* Choledochoenteric anastomosis, transpapillary stent or sphincterotomy of duodenal papilla;
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant and lactating women are ineligible

Where it's running

• University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting
• UC San Diego
  La Jolla, California, United States Active not recruiting
• University of Miami Miller School of Medicine-Sylvester Cancer Center
  Miami, Florida, United States Active not recruiting
• UM Sylvester Comprehensive Cancer Center at Plantation
  Miami, Florida, United States Active not recruiting
• Roswell Park Comprehensive Cancer Center
  Buffalo, New York, United States Active not recruiting

Study contacts

• Principal investigator: Michael Soulen — University of Pennsylvania
• Study coordinator: Michael Soulen, MD
• Email: michael.soulen@pennmedicine.upenn.edu
• Phone: 855-216-0098

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Exploring new biomarkers for diagnosing and treating neuroendocrine tumors

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• New DLL3 PET/CT imaging for neuroendocrine tumors compared with standard scans

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• CTX-471 for NCAM-positive metastatic neuroendocrine tumors

  A phase 2 trial is testing CTX-471 in adults with NCAM (CD56) positive metastatic neuroendocrine tumors that have progressed after standard therapy.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.