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Bile Duct AdenocarcinomaPhase 1NCT03117855

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

A Phase 1 study testing Capecitabine, Laboratory Biomarker Analysis and Radioembolization in people with Bile Duct Adenocarcinoma and Stage III Intrahepatic Cholangiocarcinoma, run by City of Hope Medical Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Capecitabine, Laboratory Biomarker Analysis and Radioembolization
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Dec 2016to Jun 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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)
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  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope Medical Center

    Duarte, California, 91010

Other trials in United States

About this study

Official title: A Phase I Clinical Trial of Capecitabine and SIR-Spheres® Y-90-Radioembolization in Patients With Advanced Intrahepatic Cholangiocarcinoma

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the safety and toxicity of capecitabine, to be used in combination with yttrium Y-90 (yttrium 90) (Y-90) radioembolization (RE), in patients with a diagnosis of unresectable intrahepatic cholangiocarcinoma (ICC).

SECONDARY OBJECTIVES:

  1. To describe the toxicities associated with Y-90 + capecitabine in patients with ICC.

II. To develop a preliminary assessment of efficacy by evaluating liver-specific progression-free survival (PFS) and overall PFS.

III. To develop a preliminary assessment of efficacy by evaluating response rate according to Response Evaluation Criteria in Solid Tumors (RECIST)/modified RECIST (mRECIST) and the Europeans Association for the Study of the Liver (EASL) imaging criteria.

IV. To develop a preliminary assessment of efficacy by evaluating cancer antigen (CA) 19-9 response and its correlation with imaging markers of tumor response.

  1. To develop a preliminary assessment of efficacy by evaluating duration of response in the liver, as measured by the time for target liver lesions to progress according to RECIST/mRECIST beyond size at study enrollment.

VI. To develop a preliminary assessment of efficacy by evaluating rate of conversion to surgical resection for subjects who are surgically unresectable at presentation due to size or location of hepatic lesions (excluding subjects with extrahepatic disease or medically inoperable at presentation).

VII. To develop a preliminary assessment of efficacy by evaluating overall survival.

OUTLINE:

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

After completion of study treatment, patients are followed up every 2 months.

Being tested
Capecitabine, Laboratory Biomarker Analysis, Radioembolization
Medical subject headings
Cholangiocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CapecitabineDrug

    Also called Ro 09-1978/000, Xeloda

    Given PO

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • RadioembolizationRadiation

    Also called intra-arterial brachytherapy

    Undergo yttrium Y-90 radioembolization

Study groups in NCT03117855
Study groupRoleWhat they receive
Treatment (capecitabine, yttrium Y-90 radioembolization)ExperimentalPatients undergo yttrium Y 90 resin microspheres radioembolization over 60-90 minutes on day 1. Patients receive capecitabine PO BID on days 1-14.
Receives: Drug: Capecitabine; Other: Laboratory Biomarker Analysis; Radiation: Radioembolization

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to day 45

Secondary outcomes (6)

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

    Duration of response will be calculated independently of PFS in order to evaluate the possibility that progression may occur after an initial tumor shrinkage.

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

  2. Levels of CA 19-9 response

    CA 19-9 will be assessed after Y-90 and will be compared to other measures of disease response using Pearson correlation or similar methods.

    Measured: Up to 48 months

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

    Evaluated using Kaplan-Meier analysis.

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

  4. Overall survival

    Evaluated using Kaplan-Meier analysis.

    Measured: Up to 48 months

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

    Evaluated using Kaplan-Meier analysis.

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

  6. Rate of conversion to surgical candidacy

    Measured: Up to 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2017
  2. Study startDec 2016
  3. Primary completionJun 2019 (estimated)

Why it stopped: Company no longer interested in supporting this trial

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03117855
Sponsor's protocol ID
16148
Other IDs
NCI-2016-01098, 16148
Status last verified
Apr 2017
First submitted
27 Jul 2016
Last updated
18 Apr 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Capecitabine, Laboratory Biomarker Analysis and Radioembolization in people with Bile Duct Adenocarcinoma and Stage III Intrahepatic Cholangiocarcinoma, run by City of Hope Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Up to day 45). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03117855.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2017.

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