Liver MetastasesNCT01631539
Chemoembolisation With CPT11 Loaded DC Bead With Cetuximab and 5FU/LV in First Line in Patients With KRAS Wildtype mCRC
A study testing DC Bead™, Cetuximab and 5 FU in people with Liver Metastases and Colorectal Cancer, run by Universitaire Ziekenhuizen KU Leuven.
Trial summary
The purpose of this study is to assess feasibility of chemoembolization with DC Bead loaded with Irinotecan in combination with Cetuximab and 5FU/LV as a first line treatment for wildtype KRAS unresectable liver metastases from colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Metastases, Colorectal Cancer
- What is being tested?
- DC Bead™, Cetuximab and 5 FU
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Dec 2014
- Phase
- Interventional
- 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
- Confirmed diagnosis of stage IV KRAS wild-type colorectal adenocarcinoma, with metastases predominantly in the liver (≥80% of tumor burden) that are deemed unresectable.
- Primary tumour has been treated with complete surgical resection without evidence of residual tumour
- Patients must have at least 1 measurable lesion (RECIST criteria)
- Performance status ECOG 0-1
- Aged ≥18 years
- Life expectancy > 3 months
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- No prior chemotherapy for metastatic disease
- Hematologic function: WBC ≥ 3.0 x 10*9/L, platelets ≥ 100 x10*9/L
- Adequate organ function as measured by:
- Serum creatinine £ 1.5 x upper limit of normal (ULN)
- Serum transaminases (AST \& ALT) £ 5 x ULN
- Bilirubin> 1.5 times the upper limit of the normal range
- Women of child bearing potential and fertile men are required to use effective contraception (negative βHCG for women of child-bearing age)
- Signed, written informed consent
- Patients with patent main portal vein
- Maximum liver involvement ≤60%
Who cannot join
- Presence of CNS metastases
- Contraindications to FU/LV, Irinotecan or Cetuximab
- Active bacterial, viral or fungal infection within 72 hours of study entry
- Women who are pregnant or breast feeding
- Allergy to contrast media or history of severe hypersensitivity to study drugs.
- Presence of another concurrent malignancy. Prior malignancy in the last 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
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- Any contraindication for hepatic embolization procedures:
- porto-systemic shunt
- hepatofugal blood flow
- severe atheromatosis
- Contraindication to hepatic artery catheterization, such as a patient with severe peripheral vascular disease precluding catheterization
- Other significant medical or surgical condition, or any medication or treatment regimens, that would place the patient at undue risk, that would preclude the safe use of chemoembolization or would interfere with study participation
About this study
Official title: Chemoembolisation With Irinotecan Loaded DC Bead (DEBIRI) in Combination With Cetuximab and 5FU/LV in the First Line Treatment of Patients With KRAS Wildtype Metastatic Colorectal Cancer (mCRC)
The purpose of this study is to assess feasibility of chemoembolization with DC Bead loaded with Irinotecan in combination with Cetuximab and 5FU/LV as a first line treatment for wildtype KRAS unresectable liver metastases from colorectal cancer.
Read the detailed description
20 patients will be included. The duration of the trial will be approximately 24 months.
Every 8 weeks there will be a tumour lesion assessment.
- Conditions
- Liver Metastases, Colorectal Cancer
- Being tested
- DC Bead™, Cetuximab, 5 FU, Irinotecan
- Keywords
- chemoembolization, DC Bead™, Irinotecan, Cetuximab, 5FU/LV, KRAS, metastatic colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC Bead™Device
Also called Irinotecan
chemoembolization with DC Bead™ loaded with Irinotecan
CetuximabDrug
Also called Erbitux
400 mg/m² IV at day 1 followed by 250 mg/m² IV weekly
5 FUDrug
Also called 5 fluoro uracyl
every 2 weeks IV
IrinotecanDrug
every 4 weeks chemoembolization
| Study group | Role | What they receive |
|---|---|---|
| Chemoembolization | Other | chemoembolization with DC Bead™ loaded with Irinotecan Receives: Device: DC Bead™; Drug: Cetuximab; Drug: 5 FU; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of chemoembolization with DC Bead loaded with Irinotecan
Feasibility of the study by measuring the number of enrolled patients who can finish the first cycle of treatment
Measured: after one cycle = after 8 weeks
Secondary outcomes (1)
progression-free survival
progression-free survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: No patients enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver MetastasesStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Biocompatibles UK Ltd
- Responsible party
- Principal investigator, Prof. Dr. Eric Van Cutsem, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Eric Van Cutsem, MD PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01631539
- Sponsor's protocol ID
- 2010-018384-42
- Status last verified
- Dec 2014
- First submitted
- 14 Sep 2011
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemoembolisation With Irinotecan Loaded DC Bead (DEBIRI) in Combination With Cetuximab and 5FU/LV in the First Line Treatment of Patients With KRAS Wildtype Metastatic Colorectal Cancer (mCRC)
- ClinicalTrials.gov ID
- NCT01631539
- Acronym / sponsor ID
- 2010-018384-42
- Conditions
- Liver Metastases, Colorectal Cancer
- Keywords
- chemoembolization, DC Bead™, Irinotecan, Cetuximab, 5FU/LV, KRAS, metastatic colorectal cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Biocompatibles UK Ltd
- Study start
- Sep 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess feasibility of chemoembolization with DC Bead loaded with Irinotecan in combination with Cetuximab and 5FU/LV as a first line treatment for wildtype KRAS unresectable liver metastases from colorectal cancer.
Detailed description
20 patients will be included. The duration of the trial will be approximately 24 months.
Every 8 weeks there will be a tumour lesion assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemoembolization | Other | Device: DC Bead™, Drug: Cetuximab, Drug: 5 FU, Drug: Irinotecanchemoembolization with DC Bead™ loaded with Irinotecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Confirmed diagnosis of stage IV KRAS wild-type colorectal adenocarcinoma, with metastases predominantly in the liver (≥80% of tumor burden) that are deemed unresectable.
- Primary tumour has been treated with complete surgical resection without evidence of residual tumour
- Patients must have at least 1 measurable lesion (RECIST criteria)
- Performance status ECOG 0-1
- Aged ≥18 years
Key exclusion criteria (12 listed)
- Presence of CNS metastases
- Contraindications to FU/LV, Irinotecan or Cetuximab
- Active bacterial, viral or fungal infection within 72 hours of study entry
- Women who are pregnant or breast feeding
- Allergy to contrast media or history of severe hypersensitivity to study drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DC Bead™Also: Irinotecanchemoembolization with DC Bead™ loaded with Irinotecan | Device | Chemoembolization |
| CetuximabAlso: Erbitux400 mg/m² IV at day 1 followed by 250 mg/m² IV weekly | Drug | Chemoembolization |
| 5 FUAlso: 5 fluoro uracylevery 2 weeks IV | Drug | Chemoembolization |
| Irinotecanevery 4 weeks chemoembolization | Drug | Chemoembolization |
Primary outcome
Feasibility of chemoembolization with DC Bead loaded with Irinotecan
Time frame: after one cycle = after 8 weeks
Feasibility of the study by measuring the number of enrolled patients who can finish the first cycle of treatment
1 secondary outcome
progression-free survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Van Cutsem, MD PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
Questions about this trial
What is this clinical trial studying?
A study testing DC Bead™, Cetuximab and 5 FU in people with Liver Metastases and Colorectal Cancer, run by Universitaire Ziekenhuizen KU Leuven.
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 16 inclusion and 12 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 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Feasibility of chemoembolization with DC Bead loaded with Irinotecan (time frame: after one cycle = after 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2014.