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

NCT03117855 | Withdrawn Phase 1 DMC

• 2 other identifiers: 16148NCI-2016-01098
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bile Duct Adenocarcinoma; Stage III Intrahepatic Cholangiocarcinoma; Stage IVA Intrahepatic Cholangiocarcinoma; Stage IVB Intrahepatic Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• Incidence of dose limiting toxicities (DLT) defined as any grade 3 or above toxicity assessed by the National Cancer Institute Common Terminology for Adverse Events version 4.0

  The toxicities observed at each dose level will be summarized in terms of type, severity, time of onset, duration, and reversibility or outcome. Tables will be created to summarize these toxicities. Tabular and graphical summaries will be used to explore the relationship of type and grade toxicity to other clinical parameters such as disease response and the presence of other comorbidities.

  Up to day 45

Secondary Outcomes (6)

• Duration of response according to RECIST v1.1, mRECIST, and EASL criteria

  Time until tumors progress beyond the values measured at baseline, assessed up to 48 months

• Levels of CA 19-9 response

  Up to 48 months

• Liver-specific PFS according to RECIST v1.1, mRECIST, and EASL criteria

  Time until tumors progress beyond the values measured at baseline, assessed up to 48 months

• Overall survival

  Up to 48 months

• PFS according to RECIST v1.1, mRECIST, and EASL criteria

  Time until tumors progress beyond the values measured at baseline, assessed up to 48 months

Study Arms (1)

Treatment (capecitabine, yttrium Y-90 radioembolization)

EXPERIMENTAL

Patients undergo yttrium Y 90 resin microspheres radioembolization over 60-90 minutes on day 1. Patients receive capecitabine PO BID on days 1-14.

Drug: Capecitabine; Other: Laboratory Biomarker Analysis; Radiation: Radioembolization

Interventions

Capecitabine DRUG

Given PO

Also known as: Ro 09-1978/000, Xeloda

Treatment (capecitabine, yttrium Y-90 radioembolization)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (capecitabine, yttrium Y-90 radioembolization)

Radioembolization RADIATION

Undergo yttrium Y-90 radioembolization

Also known as: intra-arterial brachytherapy

Treatment (capecitabine, yttrium Y-90 radioembolization)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

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)

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jonathan Kessler, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2016
• First Posted: April 18, 2017
• Study Start: December 1, 2016
• Primary Completion: June 1, 2019
• Last Updated: April 18, 2017

Record last verified: 2017-04

Locations

US (1)