Liver Metastases Clinical Trial
— CapTemY90Official title:
UPCC04219 Phase 2 Study of Capecitabine-Temozolomide (CapTem) With Yttrium-90 Radioembolization in the Treatment of Patients With Unresectable Metastatic Grade 2 Neuroendocrine Tumors
Grade 2 neuroendocrine tumors have an intermediate rate of progression following embolotherapy of liver metastases. The combination of capecitabine and temozolomide has been shown to be an active regimen in this disease. Both drugs are radiosensitizers, and in a safety and feasibility study were combined with yttrium-90 radioembolization with acceptable additive toxicities and better than expected response and duration of disease control. This study expands use of this regimen in a Phase 2 investigation to confirm efficacy of the integrated chemoradiation technique.
Status | Recruiting |
Enrollment | 55 |
Est. completion date | December 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients with confirmed diagnosis of histologic grade 2 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 serum ßHCG for women of child-bearing age) Exclusion Criteria: - Contraindications to capecitabine 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 trial - 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, - Pregnant and lactating women are ineligible |
Country | Name | City | State |
---|---|---|---|
United States | Abramson Cancer Center | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Abramson Cancer Center of the University of Pennsylvania | CARTI, Roswell Park Cancer Institute |
United States,
Soulen MC, van Houten D, Teitelbaum UR, Damjanov N, Cengel KA, Metz DC. Safety and Feasibility of Integrating Yttrium-90 Radioembolization With Capecitabine-Temozolomide for Grade 2 Liver-Dominant Metastatic Neuroendocrine Tumors. Pancreas. 2018 Sep;47(8):980-984. doi: 10.1097/MPA.0000000000001115. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | intra-hepatic progression-free survival | Intra-hepatic progression-free survival is defined as the 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. | 2 years | |
Secondary | Overall progression-free survival | defined as the time from initiation of study therapy until first documented intra- or extra-hepatic disease progression, death due to any cause or last scan date that documented progression-free status. | 2 years | |
Secondary | Intra-hepatic and extra-hepatic tumor responses | mRECIST criteria (for intra-hepatic only) and RECIST. | 2 years | |
Secondary | toxicities | percentage of subjects experiencing any and G3-5 toxicities | 2 years | |
Secondary | Chromogrannin A level | % change in chromogrannin A levels in ng/ml | 2 years | |
Secondary | EORTC QLQ-GINET21 | Quality of Life questionnaire measured at baseline and then every 3 months for 24 months, by a validated NET-specific instrument, EORTC QLQ - GI.NET21. Scale is 0-100 with higher scores reflecting worse symptoms. | 2 years |
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