Colorectal CancerPhase 2DEBIRITUXNCT01060423
TACE With Irinotecan Drug-eluting Beads and Intravenous (IV) Cetuximab in Refractory Colorectal Cancer
A Phase 2 study testing Cetuximab, Irinotecan and Irinotecan eluting BEADS in people with Colorectal Cancer, run by Hans-Joachim Schmoll, MD at 13 sites in Germany.
Trial summary
The primary objective of this study is to evaluate the efficacy of Irinotecan Beads in combination with intravenous cetuximab versus intravenous irinotecan in combination with intravenous cetuximab in the treatment of patients with 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
- Colorectal Cancer
- What is being tested?
- Cetuximab, Irinotecan and Irinotecan eluting BEADS
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 13 sitesGermany
- Study dates
- Feb 2010to May 2015
- Phase
- Phase 2
- 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
- Patients with confirmed diagnosis of stage IV (UICC) colorectal cancer with unresectable liver metastases (primary tumour may be present) and k-ras wild-type tumours
- Patients had been treated and shown to be refractory to 5-FU (Capecitabine allowed)/oxaliplatin and/or 5-FU/irinotecan. Prior therapy with VEGF-inhibitors (e.g bevacizumab) is allowed
- Patients with at least one measurable liver metastasis, with size > 1cm (RECIST criteria)
- Patients with liver only or liver dominant disease (defined as ≥ 50 % tumour burden confined to the liver)
- Patients with a portal vein not interfering with transarterial chemoembolization (e.g. no thrombosis) as judged by the investigator
- ECOG Performance status ≤ 2
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- Life expectancy > 3 months
- Age ≥ 18 years.
- At least 4 weeks since last administration of last chemotherapy and/or radiotherapy (bone metastases may be allowed)
- Patients who received VEGF-inhibition (e.g. with bevacizumab) in prior therapy are eligible if stopped since 4-6 weeks before randomization
- Haematologic function: ANC ≥ 1.5 x 109/L, platelets ≥ 75 x109/L
- INR < 1.5 (patients on therapeutic anticoagulants are not eligible)
- Adequate liver function as measured by serum transaminases (AST \& ALT) ≤ 3 x ULN and total bilirubin ≤ 1.5 x ULN
- Adequate renal function: Serum creatinine ≤ 1.5 x ULN
- Normal level of serum magnesium
- Women of child bearing potential and fertile men are required to use effective contraception (negative serum βHCG for women of child-bearing age
- Signed, written informed consent
Who cannot join
- Presence of CNS metastases
- Contraindications to irinotecan therapy (Chronic inflammatory bowel disease and/or bowel obstruction, history of severe hypersensitivity reactions to irinotecan hydrochloride trihydrate)
- Active bacterial, viral or fungal infection within 72 hours of study entry
- Women who are pregnant or breast feeding
- Allergy to contrast media
- 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 embolisation procedures:
- Large shunt as determined by the investigator (pretesting with lung perfusion scan not required)
- Severe atheromatosis
- Hepatofugal blood flow
- Other significant medical or surgical condition, or any medication or treatment, that would place the patient at undue risk, that would preclude the safe use of chemoembolization or would interfere with study participation
- Known hypersensitivity or contraindication to the drugs used in the trial (eg: cetuximab, 5-HT3 receptor antagonist, dexamethasone, or any component of aprepitant)
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Germany13 sites
Zentralklinik Bad Berka GmbH, Abteilung für Interventionelle Radiologie
Bad Berka, 99437
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dresden, Dresden, 01307
Kliniken Essen-Mitte, Klinik für Innere Medizin IV
Essen, 45136
Klinikum Esslingen, Klinik für Onkologie, Gastroenterologie und Allgemeine Innere Medizin
Esslingen am Neckar, 73730
Krankenhaus Nordwest
Frankfurt/M., 60488
Universitätsklinikum der Johann Wolfgang Goethe Universität Frankfurt
Frankfurt/M., 60590
Martin-Luther-Universität Halle-Wittenberg
Halle, 06097
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
SLK-Kliniken Heilbronn
Heilbronn, 74078
Otto-von-Guericke-Universität Magdeburg
Magdeburg, 39120
Universitätsklinikum Regensburg
Regensburg, 93053
Universitätsklinikum Tübingen, Medizinische Klinik und Poliklinik II
Tübingen, 72076
Universitätsklinikum Würzburg, Institut für Röntgendiagnostik
Würzburg, 97080
About this study
Official title: A Randomized Phase II Trial of Irinotecan Drug-eluting Beads Administered by Hepatic Chemoembolization With Intravenous Cetuximab (DEBIRITUX) Versus Systemic Treatment With Intravenous Cetuximab and Irinotecan in Patients With Refractory Metastatic Colorectal Cancer and K-ras Wild-type Tumours
The primary objective of this study is to evaluate the efficacy of Irinotecan Beads in combination with intravenous cetuximab versus intravenous irinotecan in combination with intravenous cetuximab in the treatment of patients with unresectable liver metastases from colorectal cancer.
Secondary objectives are safety and tolerability of hepatic chemoembolization and the question if the addition of aprepitant to standard antiemetic prophylaxis in patients treated by hepatic chemoembolization is safe and will reduce the rate of acute and delayed nausea and emesis.
Read the detailed description
About half of patients with newly diagnosed colorectal cancer will develop metastatic disease and, however, in spite of the significant progress in the therapeutical strategies for metastatic disease, virtually all patients will eventually succumb to their illness. Based on prior clinical data there is a good rationale for the expectation that the combination of systemic chemotherapy and arterial chemoembolization with drug eluting beads may be effective in the setting of patients with unresectable or chemorefractory liver metastases. The aim of this study is therefore to assess whether the combination of Irinotecan eluting beads and intravenous cetuximab is safe and effective in the treatment of patients with unresectable liver metastases from refractory colorectal cancer and will result in a prolongation of disease control when compared to standard systemic treatment with intravenous irinotecan and intravenous cetuximab. In this patient group, intravenous irinotecan plus intravenous cetuximab may represent the "standard of care", with a previously described activity. The patient group is defined in terms of pretreatment, and the scientific question is whether the way of irinotecan administration by eluting beads in feasible and somehow beneficial.
- Conditions
- Colorectal Cancer
- Being tested
- Cetuximab, Irinotecan, Irinotecan eluting BEADS
- Keywords
- colorectal, liver metastasis, KRAS wildtype, chemoembolization, irinotecan eluting beads
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Also called Erbitux
Starting dose of 400mg/m2, followed by weekly 250mg/m2
IrinotecanDrug
Irinotecan 180 mg/m² to be administered every two weeks
Irinotecan eluting BEADSDevice
Also called DC Bead
A minimum of two treatments per lobe (four bi-weekly sessions in the event of bilobar disease) at week 0 and 4 with up to 4ml (100-300µm DC Bead loaded with up to 200mg irinotecan) will be scheduled (i.e. for bilobar disease right lobe: week 0, left lobe: week 2, right lobe: week 4 and left lobe: week 6: following toxicity and extending interval if toxicity seen).
| Study group | Role | What they receive |
|---|---|---|
| hepatic TACE with irinotecan eluting beads and iv cetuximab | Experimental | Irinotecan drug-eluting beads administered by hepatic chemoembolization with intravenous cetuximab (DEBIRITUX) Receives: Drug: Cetuximab; Device: Irinotecan eluting BEADS |
| iv cetuximab and irinotecan | Active comparator | systemic treatment with intravenous cetuximab and irinotecan Receives: Drug: Cetuximab; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival rate
Measured: 6 months after first administration of study medication
Secondary outcomes (5)
Tumour Response (according to RECIST v1.1)
extent of treated lesions
Measured: every three months up to progression of disease, maximum 12 months from the date of patient enrolment
Time to progression
Measured: every three months, until death of patient, maximum 12 months from the date of patient enrolment
Number of adverse events in study patients
Measured: whole study, every two weeks until 28 days from the date of last administration of study medication
Local tumour response
extent of necrosis in the treated lesions
Measured: every three months up to progression of disease, maximum 12 months from the date of patient enrolment
Overall survival
Measured: every three months, until death of patient, maximum 12 months from the date of last patient enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2012
- Study completionMay 2015
Why it stopped: Terminated due to poor subject enrolment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hans-Joachim Schmoll, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Biocompatibles UK Ltd
- Responsible party
- Sponsor-investigator, Hans-Joachim Schmoll, MD, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Dirk Arnold, MD, Principal investigator, Universitätsklinikum Eppendorf, Universitäres Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060423
- Sponsor's protocol ID
- EudraCT: 2009-014728-44
- Acronym
- DEBIRITUX
- Status last verified
- Oct 2016
- First submitted
- 27 Jan 2010
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial of Irinotecan Drug-eluting Beads Administered by Hepatic Chemoembolization With Intravenous Cetuximab (DEBIRITUX) Versus Systemic Treatment With Intravenous Cetuximab and Irinotecan in Patients With Refractory Metastatic Colorectal Cancer and K-ras Wild-type Tumours
- ClinicalTrials.gov ID
- NCT01060423
- Acronym / sponsor ID
- DEBIRITUX / EudraCT: 2009-014728-44
- Conditions
- Colorectal Cancer
- Keywords
- colorectal, liver metastasis, KRAS wildtype, chemoembolization, irinotecan eluting beads
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to poor subject enrolment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Hans-Joachim Schmoll, MDUniversity, hospital or other
- Collaborators
- Biocompatibles UK Ltd
- Study start
- Feb 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 2 Feb 2010 (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 primary objective of this study is to evaluate the efficacy of Irinotecan Beads in combination with intravenous cetuximab versus intravenous irinotecan in combination with intravenous cetuximab in the treatment of patients with unresectable liver metastases from colorectal cancer.
Secondary objectives are safety and tolerability of hepatic chemoembolization and the question if the addition of aprepitant to standard antiemetic prophylaxis in patients treated by hepatic chemoembolization is safe and will reduce the rate of acute and delayed nausea and emesis.
Detailed description
About half of patients with newly diagnosed colorectal cancer will develop metastatic disease and, however, in spite of the significant progress in the therapeutical strategies for metastatic disease, virtually all patients will eventually succumb to their illness. Based on prior clinical data there is a good rationale for the expectation that the combination of systemic chemotherapy and arterial chemoembolization with drug eluting beads may be effective in the setting of patients with unresectable or chemorefractory liver metastases. The aim of this study is therefore to assess whether the combination of Irinotecan eluting beads and intravenous cetuximab is safe and effective in the treatment of patients with unresectable liver metastases from refractory colorectal cancer and will result in a prolongation of disease control when compared to standard systemic treatment with intravenous irinotecan and intravenous cetuximab. In this patient group, intravenous irinotecan plus intravenous cetuximab may represent the "standard of care", with a previously described activity. The patient group is defined in terms of pretreatment, and the scientific question is whether the way of irinotecan administration by eluting beads in feasible and somehow beneficial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hepatic TACE with irinotecan eluting beads and iv cetuximab | Experimental | Drug: Cetuximab, Device: Irinotecan eluting BEADSIrinotecan drug-eluting beads administered by hepatic chemoembolization with intravenous cetuximab (DEBIRITUX) |
| iv cetuximab and irinotecan | Active comparator | Drug: Cetuximab, Drug: Irinotecansystemic treatment with intravenous cetuximab and irinotecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients with confirmed diagnosis of stage IV (UICC) colorectal cancer with unresectable liver metastases (primary tumour may be present) and k-ras wild-type tumours
- Patients had been treated and shown to be refractory to 5-FU (Capecitabine allowed)/oxaliplatin and/or 5-FU/irinotecan. Prior therapy with VEGF-inhibitors (e.g bevacizumab) is allowed
- Patients with at least one measurable liver metastasis, with size > 1cm (RECIST criteria)
- Patients with liver only or liver dominant disease (defined as ≥ 50 % tumour burden confined to the liver)
- Patients with a portal vein not interfering with transarterial chemoembolization (e.g. no thrombosis) as judged by the investigator
Key exclusion criteria (12 listed)
- Presence of CNS metastases
- Contraindications to irinotecan therapy (Chronic inflammatory bowel disease and/or bowel obstruction, history of severe hypersensitivity reactions to irinotecan hydrochloride trihydrate)
- Active bacterial, viral or fungal infection within 72 hours of study entry
- Women who are pregnant or breast feeding
- Allergy to contrast media
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 |
|---|---|---|
| CetuximabAlso: ErbituxStarting dose of 400mg/m2, followed by weekly 250mg/m2 | Drug | hepatic TACE with irinotecan eluting beads and iv cetuximab, iv cetuximab and irinotecan |
| IrinotecanIrinotecan 180 mg/m² to be administered every two weeks | Drug | iv cetuximab and irinotecan |
| Irinotecan eluting BEADSAlso: DC BeadA minimum of two treatments per lobe (four bi-weekly sessions in the event of bilobar disease) at week 0 and 4 with up to 4ml (100-300µm DC Bead loaded with up to 200mg irinotecan) will be scheduled (i.e. for bilobar disease right lobe: week 0, left lobe: week 2, right lobe: week 4 and left lobe: week 6: following toxicity and extending interval if toxicity seen). | Device | hepatic TACE with irinotecan eluting beads and iv cetuximab |
Primary outcome
Progression free survival rate
Time frame: 6 months after first administration of study medication
5 secondary outcomes
Tumour Response (according to RECIST v1.1)
Time frame: every three months up to progression of disease, maximum 12 months from the date of patient enrolment
Time to progression
Time frame: every three months, until death of patient, maximum 12 months from the date of patient enrolment
Number of adverse events in study patients
Time frame: whole study, every two weeks until 28 days from the date of last administration of study medication
Local tumour response
Time frame: every three months up to progression of disease, maximum 12 months from the date of patient enrolment
Overall survival
Time frame: every three months, until death of patient, maximum 12 months from the date of last patient enrolment
Results and safety
The study was stopped early (reason given: Terminated due to poor subject enrolment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
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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.
Dirk Arnold, MD principal investigator
Universitätsklinikum Eppendorf, Universitäres Cancer Center
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximab, Irinotecan and Irinotecan eluting BEADS in people with Colorectal Cancer, run by Hans-Joachim Schmoll, MD at 13 sites in Germany.
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 17 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: stopped early, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany. 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?
The study was stopped early (reason given: Terminated due to poor subject enrolment). Results are not available in the source record.
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?
Progression free survival rate (time frame: 6 months after first administration of study medication). 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 26 Oct 2016.