Capecitabine and Y-90 Radioembolization in Treating Patients With Advanced Bile Duct Cancer in the Liver That Cannot Be Removed by Surgery

Withdrawn before enrolling · Phase 1

Conditions studied: Bile Duct Adenocarcinoma, Stage III Intrahepatic Cholangiocarcinoma, Stage IVA Intrahepatic Cholangiocarcinoma, Stage IVB Intrahepatic Cholangiocarcinoma

In brief

This phase I trial studies the side effects of capecitabine and Y-90 radioembolization in treating patients with bile duct cancer in the liver that has spread to other places in the body and cannot be removed by surgery. Radiation therapy, such as Y-90 radioembolization, injects tiny radioactive Y-90 microspheres into the blood supply next to the liver tumors to kill tumor cells. Capecitabine may make radiation more effective. Giving capecitabine and Y-90 radioembolization may work better in treating patients with bile duct cancer in the liver.

Key facts

Study ID

NCT03117855

Run by

City of Hope Medical Center

People needed

0

Starts

2016-12-01

Last updated by the study team

2017-04-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented informed consent of the participant and/or legally authorized representative
• Eastern Cooperative Oncology Group performance status 0-2
• Life expectancy > 3 months
• Intrahepatic cholangiocarcinoma; a histological diagnosis is mandated; a diagnosis of adenocarcinoma with staining pattern consistent with cholangiocarcinoma and with a clinical presentation consistent with cholangiocarcinoma will be acceptable for enrollment as this is a typical intrahepatic cholangiocarcinoma presentation
• Primary tumor deemed unresectable by hepatobiliary surgeon
• Absence of the following:
• Malignant ascites
• Extensive carcinomatosis (in the opinion of the investigator)
• Bulky, diffuse adenopathy (> 5 lymph nodes > 2 cm each)
• Extensive metastatic disease to the lungs (> 5 tumors > 2 cm each)
• Has completed pre-RE angiogram up to 3 weeks prior to Y-90 therapy
• Lung shunt fraction =< 20% and anatomy amenable to intra-arterial radiation delivery
• Extrahepatic vessels deemed at risk for radiation injury were successfully embolized
• Prior systemic chemotherapy must be completed > 2 weeks of radioembolization
• Negative serum or urine beta-human chorionic gonadotropin (HCG) test (female patient of childbearing potential only)
• Platelets (PLT) >= 100,000/mm\^3
• Absolute neutrophil count (ANC) >= 1500 cells/mm\^3
• Creatinine clearance of > 50 mL/min per 24 hour urine collection of the Cockcroft-Gault formula
• Hemoglobin > 9 g/dL
• Total bilirubin < 2 mg/dL
• Agreement by females of childbearing potential and sexually active males to use an effective method of contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and until at least 180 days after administration of any study agent; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately

You may not qualify if…

• Prior selective internal radiation to the liver
• Prior warfarin-based therapies within 7 days of capecitabine treatment
• Actively receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
• Neuropathy >= grade 2 (moderate neuropathy that limits instrumental activities of daily living)
• History of main or lobar portal vein thrombosis
• History of biliary stent, internal biliary drain, or prior procedure compromising the ampulla of Vater (diagnostic endoscopic retrograde cholangiopancreatography [ERCP] is permissible)
• Known dihydropyrimidine dehydrogenase deficiency
• History of allergic reactions attributed to:
• Study agent or its metabolites
• Iodinated contrast media
• Pregnant or breastfeeding (women)
• Concurrent diagnosis of other active malignancies with the exception of ductal carcinoma in situ, cervical carcinoma in situ, and localized non-melanoma skin cancer
• Any clinically significant uncontrolled illness including ongoing active infection
• Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Where it is running

• City of Hope Medical Center — Duarte, California, United States

Full record on ClinicalTrials.gov

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