Phase
Condition
Digestive System Neoplasms
Carcinoid Syndrome And Carcinoid Tumours
Neoplasms
Treatment
Temozolomide Oral Product
Capecitabine Oral Product
transarterial radioembolization
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients with confirmed diagnosis of histologic grade 2 neuroendocrine tumor withunresectable liver metastases (primary tumor or other extrahepatic disease may bepresent)
Patients with at least one measurable liver metastases, with size > 1cm (RECISTcriteria)
Patients with liver dominant disease defined as ≥50% tumor body burden confined tothe 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 ≤5times 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 consentdocument.
Women of child bearing potential and fertile men are required to use effectivecontraception (negative urine or serum βHCG for women of child-bearing age)
Exclusion
Exclusion Criteria:
Contraindications to capecitibine or temozolomide
Contraindicated for both contrast-enhanced MRI and CT
Patients previously treated with transarterial embolization (with or withoutchemotherapy) 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 ofextra-hepatic structures
Subjects consenting to the trial who fail their simulation angiography will beremoved from the study and replaced.
Patients may not be receiving any other investigational agents.
Absolute contraindication to intravenous iodinated contrast (Hx of significantprevious contrast reaction, not mitigated by appropriate pre-medication).
Choledochoenteric anastomosis, transpapillary stent or sphincterotomy of duodenalpapilla;
Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliancewith study requirements.
Pregnant and lactating women are ineligible
Study Design
Study Description
Connect with a study center
CARTI Cancer Center
Little Rock, Arkansas 72205
United StatesSite Not Available
UC San Diego
La Jolla, California 92037
United StatesActive - Recruiting
Roswell Park Comprehensive Cancer Center
Buffalo, New York 14203
United StatesActive - Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania 19103
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.