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Colorectal CancerPhase 2NCT02015754

Irinotecan -Eluting LC Bead-M1 (DEBIRI-M1) for Patients With Liver Metastases From Colorectal Cancer

A Phase 2 study testing DEBIRI, LC Bead M1 and TACE in people with Colorectal Cancer, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Purpose: The purpose of this study is to determine the feasibility and safety of using small beads (70-150 micron in place of 100-300 micron) to deliver chemotherapy into the liver to treat patients with liver lesions from colorectal cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
DEBIRI, LC Bead M1 and TACE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
Feb 2014to 13 Dec 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • -Patients with a diagnosis of colorectal cancer with hepatic metastases who have failed or are intolerant to at least one systemic chemotherapy or liver directed therapy.
  • The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at study entry.
  • The patient is age 18 years or older.
  • The patient has a life expectancy of >12 weeks.
  • Patients with liver dominant disease defined as >/=75% tumor body burden confined to the liver
  • Less than 60% liver tumor replacement
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  • At least one month has elapsed since most recent prior cancer therapy with the following exception:
  • -Chemotherapy (excluding irinotecan based regimens) may continue if there is evidence of hepatic progression on treatment providing there is no change in the therapy in the 1 month prior to DEBIRI-TACE treatment and any immediate chemotherapeutic toxicity that will complicate DEBIRI-TACE is resolved. In this case, the chemotherapy may continue because it is continuing to control the extrahepatic disease.
  • The patient has measurable disease that will be directly treated with intrahepatic therapy (as defined by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1).
  • Patients with at least one measurable liver metastases> 2 cm.
  • Patients with patent main portal vein
  • The patient has adequate hematologic function as defined by the following criteria:
  • -An absolute neutrophil count (ANC) >/= 1500/mL, Hemoglobin >/= 9.5 g/dL, and a Platelet count >/=75,000/mL, INR </=1.3 prior to receiving DEBIRI-TACE.
  • The patient has adequate hepatic function, as defined by the following criteria:
  • -Total bilirubin</= 2.0 mg/dL, Aspartate transaminase (AST) and alanine transaminase (ALT) </= 5 x the upper limit of normal (ULN), Albumin >2.
  • The patient has adequate renal function, as defined by the following criteria:
  • -Serum creatinine</=2.0.
  • The patient has a baseline international normalized ratio (INR)<1.5.
  • The patient, if a woman of childbearing potential, has a negative pregnancy test.
  • The patient is able to give written informed consent.
  • The patient is willing and able to comply with study procedures, scheduled visits, and treatment plans.

Who cannot join

  • The patient has a history of another primary cancer (ie, a primary cancer not associated with the patient's current liver tumor), with the exception of (a) curatively resected nonmelanomatous skin cancer; (b) curatively treated cervical carcinoma in situ; or (c) other primary solid tumor treated with curative intent, no known active disease present, and no treatment administered during the last 3 years prior to enrollment (date of informed consent).
  • Any contraindication for hepatic embolization procedures:
  • Large shunt as determined by the investigator (pretesting with TcMMA not required)
  • Severe atheromatosis
  • Hepatofugal blood flow
  • Main portal vein occlusion (e.g. thrombus or tumor)
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  • Any patient eligible for curative treatment (i.e. resection or radiofrequency ablation)
  • Patients' whose only measurable disease is within an area of the liver previously subject to radiotherapy
  • Contraindications to irinotecan:
  • Chronic inflammatory bowel disease and/or bowel obstruction
  • History of severe hypersensitivity reactions to irinotecan hydrochloride trihydrate, lactic acid or to any of the excipients of Camptosar
  • Severe bone marrow failure
  • History of Gilbert Syndrome (specific testing not required)
  • Concomitant use with St John's Wort (Hypericum)
  • Marco-shunting noted on the hepatic angiogram.
  • The patient has untreatable bleeding diathesis.
  • The patient has complete main portal vein thrombosis with reversal of flow.
  • The patient has evidence of clinically significant peripheral vascular disease.
  • The patient has brain metastases
  • The patient has clinically significant or symptomatic extrahepatic disease, for example, an uncontrolled intercurrent illness including, but not limited to:
  • Ongoing or active infection requiring parenteral antibiotics
  • Symptomatic congestive heart failure (class II to IV of the New York Heart Association classification for heart disease)
  • Unstable angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months
  • Uncontrolled hypertension (systolic blood pressure>150 mmHg, diastolic blood pressure>90 mmHg, found on 2 consecutive measurements separated by a 1-week period despite adequate medical support)
  • Clinically significant cardiac arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia that is symptomatic or requires treatment [NCI-CTCAE Grade 3] or asymptomatic sustained ventricular tachycardia)
  • The patient is pregnant or breast-feeding.
  • Psychiatric illness/social situations that would compromise patient safety or limit compliance with study requirements
  • There is evidence of substance abuse or medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of study results
  • The patient is allergic to contrast media that cannot be readily prevented with premedication or managed.
  • Other significant medical or surgical condition, or any medication or treatment, that would place the patient at undue risk and that would preclude the safe use of chemoembolization or would interfere with study participation
  • The patient has peritoneal disease or ascites (greater than trace on imaging).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21287

Other trials in United States

About this study

Purpose:

The purpose of this study is to determine the feasibility and safety of using small beads (70-150 micron in place of 100-300 micron) to deliver chemotherapy into the liver to treat patients with liver lesions from colorectal cancer. The beads (LC-Bead M1) will be loaded with irinotecan (DEBIRI-M1), and used to administer transarterial chemoembolization (TACE).

Read more

Eligibility:

Patients with liver cancer from colorectal cancer.

Study Overview/ Treatment:

DEBIRI, loaded with irinotecan, is a device that utilizes tiny beads (70-150 microns) to deliver chemotherapy agents into liver tumor(s) via the hepatic artery. This device allows for continuous release of irinotecan into the liver tumor tissue(s) causing necrosis of the targeted tumor(s). The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. Response to therapy will be evaluated monthly by clinic visits and blood tests (to include assessment of liver function and tumor markers) and by imaging (usually MRIs) every 1-2 months. Patients will be on study for 6 months after which they will be exited from the study and followed for survival. Once exited from the study they will continue to be eligible to receive DEBIRI, should it be recommended.

Being tested
DEBIRI, LC Bead M1, TACE
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • DEBIRIDrug

    Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extracted from the tree Camptotheca acuminata. Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in DC Beads and injected in the tumor.

  • LC Bead M1Device

    The LC Bead M1, loaded with irinotecan (DEBIRI-M1) to treat patients with hepatic metastases from colorectal cancer.

  • TACEProcedure or surgery

    TACE a minimally invasive procedure performed to restrict a tumor's blood supply.

Study groups in NCT02015754
Study groupRoleWhat they receive
DEBIRIExperimentalNot described
Receives: Drug: DEBIRI; Device: LC Bead M1; Procedure: TACE

What is being measured

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

  1. Success of DEBIRI-M1 Procedure as a Measure of Feasibility (Percentage of Successful Treatments)

    Feasibility is defined as achieving an acceptable level of technical success in the use of DEBIRI beads treating hepatic metastases in patients with colorectal cancer.

    Measured: 6 months

  2. Safety, Defined as Demonstrating Tolerable Device-related Toxicity Profile in the Use of DEBIRI Beads Used to Treat Hepatic Metastases in Patients With Colorectal Cancer

    Toxicities assessed as being at least possibly related will be recorded including system organ class, subclass, grade, frequency and time interval from DEBIRI-M1.

    Measured: 6 weeks

Secondary outcomes (7)

  1. Efficacy - Tumor Response by RECIST

    Efficacy as assessed by radiographic tumor response using the RECIST criteria at baseline and at 6-week imaging following TACE treatments.

    Complete Response (CR): Disappearance of all lesions targeted by DEBIRI-M1 Partial Response (PR): At least 30% decrease in sum of longest diameter (LD) of lesions targeted by DEBIRI-M1, taking as reference the baseline sum LD Progressive Disease (PD): At least 20% increase in sum of the LD Of lesions targeted by DEBIRI-M1, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, of lesions targeted by DEBIRI-M1, taking as reference the smallest sum LD since treatment started

    Measured: 24 weeks

  2. Efficacy - Tumor Response by mRECIST

    Efficacy as assessed by radiographic tumor response using modified RECIST (mRECIST) criteria at baseline and at 6-week imaging following TACE treatments.

    Complete Response (CR): Disappearance of any intratumoral arterial enhancement in all target lesions Partial Response (PR): At least 30% decrease in the sum of diameters of viable target lesions, taking as reference the baseline sum of the diameters of target lesions Progressive Disease (PD): At least 20% increase in sum of diameters of viable target lesions, taking as reference the smallest sum of diameters of viable target lesions since treatment started.

    Stable Disease (SD): Any cases that do not qualify for either PR or PD.

    Measured: 24 weeks

  3. Efficacy -Tumor Response by European Association for the Study of the Liver (EASL) Criteria

    Efficacy as assessed by radiographic tumor response using EASL amendment at baseline and at 6-week imaging following TACE treatments.

    Complete Response (CR): Achieving 100% tumor necrosis of lesions targeted by DEBIRI-M1. Baseline degree of tumor enhancement used as a reference.

    Partial Response (PR): Demonstrating greater than 50% tumor necrosis in lesions targeted by DEBIRI-M1.

    Stable Disease (SD): Not meeting requirements for CR or PR and not demonstrating evidence of progression of lesions targeted by DEBIRI-M1.

    Progressive Disease (PD): Reappearance of or increased tumor enhancement greater than 25% in lesions previously targeted by DEBIRI-M1.

    Measured: 24 weeks

  4. Efficacy - Tumor Response by World Health Organization (WHO) Criteria

    Efficacy as assessed by radiographic tumor response using WHO criteria at baseline and at 6-week imaging following TACE treatments.

    Complete Response (CR): No lesions detected for at least 4 weeks. Partial Response (PR): 50% or greater decrease in the sum of the products of diameters Stable Disease (SD): Cases that do not fit the criteria of PR or PD. Progressive Disease (PD): 25% or greater increase in the sum of the products of diameters in one or more lesions; or new lesions

    Measured: 24 weeks

  5. Number of Participants With Change in Carcinoembryonic Antigen (CEA)

    CEA measurements pre- and post- DEBIRI treatment will be recorded to ascertain if it is predictive of survival.

    Measured: 6 weeks

  6. Median Overall Survival

    Median overall survival from start of therapy (DEBIRI #1) until death (or date of censor).

    Measured: Up to 26 months

  7. One-year Survival Percentage

    Percentage of study patients surviving after one year from initial treatment analyzed with Kaplan-Meier curve.

    Measured: 1 year

Timeline

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

  1. First posted19 Dec 2013 (estimated)
  2. Study startFeb 2014
  3. Primary completion2 Jun 2015
  4. Study completion13 Dec 2016

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02015754
Sponsor's protocol ID
J1305
Other IDs
NA_00078095 [JHMIRB]
Status last verified
Feb 2018
First submitted
13 Dec 2013
Last updated
22 Mar 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DEBIRI, LC Bead M1 and TACE in people with Colorectal Cancer, run by Yale University 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 31 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: finished, as of the sponsor's last update on 22 Mar 2018. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Success of DEBIRI-M1 Procedure as a Measure of Feasibility (Percentage of Successful Treatments) (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT02015754.

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 22 Mar 2018.

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