Combination therapy for Grade 2 liver-dominant neuroendocrine tumors
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
This study is testing a new combination treatment of two drugs followed by a special radiation therapy to see if it helps people with Grade 2 liver-dominant neuroendocrine tumors live longer without their cancer getting worse.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (La Jolla, California and 3 other locations) |
| Trial ID | NCT04339036 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with unresectable Grade 2 neuroendocrine tumors and measurable liver metastases.
Not a fit: Patients with resectable tumors or those with significant extrahepatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve disease control and progression-free survival for patients with Grade 2 neuroendocrine tumors.
How similar studies have performed: Other studies have shown promise with similar combination therapies, but this specific approach is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
La Jolla, California and 3 other locations
- UC San Diego — La Jolla, California, United States (Recruiting)
- University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States (Recruiting)
- Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.