Colon Cancer With Metastases to the LiverPhase 1/2DEBIRINCT00932438
Drug-Eluting Bead, Irinotecan (DEBIRI) Therapy of Liver Metastasis From Colon Cancer With Systemic Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab
A Phase 1/2 study testing LC beads loaded with Irinotecan, Oxaliplatin and Leucovorin in people with Colon Cancer With Metastases to the Liver, run by University of Louisville at 10 sites in 2 countries.
Trial summary
This is a multicentre, open labeled, controlled phase study designed to assess effectiveness of chemoembolization with LC Beads, both with and without systemic chemotherapy, in the treatment of unresectable liver metastases in patients with colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer With Metastases to the Liver
- What is being tested?
- LC beads loaded with Irinotecan, Oxaliplatin and Leucovorin
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Jun 2009to Dec 2012
- Phase
- Phase 1/2
- 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 over 18 years of age, of any race or sex, who have histologic or radiologic proof of colorectal cancer to the liver, who are able to give informed consent, will be eligible.
- Patients with at least one measurable liver metastases, with size > 1cm response evaluation criteria in solid tumors (RECIST)
- Patients with liver dominant disease defined as ≥80% tumor body burden confined to the liver
- Patients with patent main portal vein
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of < 2
- Life expectancy of > 3 months
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- Non-pregnant with an acceptable contraception in premenopausal women.
- Hematologic function: absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelets ≥75 x109/L, international normalized ratio (INR) ≤1.3* (*If patient is on anticoagulants, they must be able to stop medication temporarily prior to TACE and must have INR ≤1.3 prior to receiving TACE) Adequate liver function as measured by: Total bilirubin ≤ 2.0mg/dl, alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤5 times upper limits of normal (ULN), albumin ≥2.5g/dl, Adequate Hemoglobin and Hematocrit as measured by (Male: for approximate 45 - 62%; and approximate Female: 37 - 48%) or Hemoglobin (Male: approximate 13 - 18 gm/dL Female: approximate 12 - 16 gm/dL). If patient is asymptomatic with Hemoglobin for male 10 to 12.9 or Female 9.5 to 11.9 and do not wish to be transfused they still will be eligible for treatment.
- Adequate renal function (creatinine ≤ 2.0mg/dl)
- Women of child bearing potential and fertile men are required to use effective contraception negative serum beta human chorionic gonadotropin (βHCG)
- Signed, written informed consent
- Patient is at least one month out from any treatment for Stage III colorectal cancer
- Patient is at least one year out from any treatment for their Stage IV colorectal cancer.
- these patients should not be candidates for curative treatments, and will have recovered from any chemotherapeutic toxicities' they may have experienced."
- Less than 60% liver tumor replacement
Who cannot join
- "Any patient eligible for curative treatment (i.e. resection or radiofrequency ablation). Note: resectability is defined as a single tumor <5cm with adequate liver function defined: Total bilirubin ≤ 2.0mg/dl" non-resectability includes patients with greater than 6, tumors close to blood vessels, patients with hepatic-pulmonary shunting, or patients of poor performance"
- Active bacterial, viral or fungal infection within 72 hours of study entry
- Women who are pregnant or breast feeding
- Allergy to contrast media that cannot be managed with standard care (e.g. steroids), making magnetic resonance imaging (MRI) or computed tomography (CT) contraindicated.
- Presence of another malignancy with the exception of cervical carcinoma in situ and stage I basal or squamous carcinoma of the skin.
- Any contraindication for hepatic embolization procedures:
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- 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)
- 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
- Patients with prior contraindications for the use of irinotecan therapy-this would include 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 or concomitant use with St. John's Wort
- Patients with prior contraindications for the use of fluorouracil, oxaliplatin, leucovorin or bevacizumab
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Emory University
Atlanta, Georgia, 30322
Northside Hospital/GA Cancer Specialists
Atlanta, Georgia, 30342
Clearview Cancer Center
Huntsville, Alabama, 35805
University of Louisville
Louisville, Kentucky, 40202
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53226
Providence Portland Medical Center/Providence Cancer Center
Portland, Oregon, 97213
Radiology Associates of Sacramento/Sutter Cancer Center
Sacramento, California, 95816
Washington University/Alvin J. Siteman Cancer Center
St Louis, Missouri, 63110
Hematology and Oncology Assoc. at Bridgeport
Tupelo, Mississippi, 38801
About this study
Official title: Drug-Eluting Bead, Irinotecan (DEBIRI) Therapy of Liver Metastasis From Colon Cancer With Concomitant Systemic Oxaliplatin, Fluorouracil and Leucovorin Chemotherapy, and Anti-Angiogenic Therapy
This is a multicentre, open labeled, controlled phase study designed to assess effectiveness of chemoembolization with LC Beads, both with and without systemic chemotherapy, in the treatment of unresectable liver metastases in patients with colorectal cancer.
Read the detailed description
This is a multicentre, open labeled, prospective, randomized, controlled phase I/II study designed to assess the clinical performance of chemoembolization with Low Compression Bead (LC Bead), loaded with irinotecan in combination with intravenous chemotherapy and bevacizumab versus intravenous chemotherapy in combination with bevacizumab in the treatment of unresectable liver metastases in patients with colorectal cancer.
- Being tested
- LC beads loaded with Irinotecan, Oxaliplatin, Leucovorin, 5-Fluorouracil, Bevacizumab
- Keywords
- colon cancer, liver metastases
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LC beads loaded with IrinotecanDevice
Also called LC Beads, TACE
Chemoembolization using LC beads loaded with 100mg Irinotecan
OxaliplatinDrug
Also called FOLFOX6
Oxaliplatin 85 mg/sqm, IV infusion every two weeks
LeucovorinDrug
Also called FOLFOX6
Leucovorin 200 mg/sqm, IV infusion every two weeks
5-FluorouracilDrug
Also called FOLFOX6
5-Fluorouracil 2400 mg/sqm, IV infusion every 2 week
BevacizumabDrug
Also called Avastin
Bevacizumab 5 mg/kg given at the discretion of the treating physician
| Study group | Role | What they receive |
|---|---|---|
| LC Beads loaded with Irinotecan and FOLFOX6 | Experimental | Device: LC Beads loaded with 100mg Irinotecan
Drug: Systemic Chemotherapy (FOLFOX6) Oxaliplatin 85 mg/sqm, IV infusion every two weeks Leucovorin 200mg/sqm, IV infusion every two weeks 5-Fluorouracil 2400mg/sqm, IV infusion every two weeks Bevacizumab 5mg/kg given at the discretion of treating physician Receives: Device: LC beads loaded with Irinotecan; Drug: Oxaliplatin; Drug: Leucovorin; Drug: 5-Fluorouracil; Drug: Bevacizumab |
| FOLFOX6 and Bevacizumab | Active comparator | Drug: Systemic Chemotherapy (FOLFOX6) Oxaliplatin 85 mg/sqm, IV infusion every two weeks Leucovorin 200mg/sqm, IV infusion every two weeks 5-Fluorouracil 2400mg/sqm, IV infusion every two weeks Bevacizumab 5mg/kg given at the discretion of treating physician Receives: Drug: Oxaliplatin; Drug: Leucovorin; Drug: 5-Fluorouracil; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Response
Tumor response will be determined using Modified Response Evaluation Criteria in Solid Tumors (mRECIST). Response will classified as: Complete response - disappearance of all lesions; Partial response - at least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter or 30% reduction of arterial enhancement; Progressive disease - at least 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest longest diameter recorded since start of treatment or appearance of one or more new lesions greater than 1cm in size; Stable disease - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since start of treatment.
Measured: Months 2, 4 and 6
Secondary outcomes (1)
Number of Serious Adverse Events
Total number of serious adverse events that occurred in both Arms of the study.
Measured: First treatment through one year post treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colon Cancer With Metastases to the LiverStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- Biocompatibles UK Ltd
- Responsible party
- Principal investigator, Robert C. Martin, University of Louisville
- Investigators
- Robert CG Martin, MD, PhD, Study director, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932438
- Sponsor's protocol ID
- DEBIRI # 09.0034
- Other IDs
- UL2008.1
- Acronym
- DEBIRI
- Status last verified
- Mar 2018
- First submitted
- 1 Jul 2009
- Last updated
- 11 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-Eluting Bead, Irinotecan (DEBIRI) Therapy of Liver Metastasis From Colon Cancer With Concomitant Systemic Oxaliplatin, Fluorouracil and Leucovorin Chemotherapy, and Anti-Angiogenic Therapy
- ClinicalTrials.gov ID
- NCT00932438
- Acronym / sponsor ID
- DEBIRI / DEBIRI # 09.0034
- Keywords
- colon cancer, liver metastases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- Biocompatibles UK Ltd
- Study start
- Jun 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 3 Jul 2009 (estimated)
- Results
- Posted 7 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicentre, open labeled, controlled phase study designed to assess effectiveness of chemoembolization with LC Beads, both with and without systemic chemotherapy, in the treatment of unresectable liver metastases in patients with colorectal cancer.
Detailed description
This is a multicentre, open labeled, prospective, randomized, controlled phase I/II study designed to assess the clinical performance of chemoembolization with Low Compression Bead (LC Bead), loaded with irinotecan in combination with intravenous chemotherapy and bevacizumab versus intravenous chemotherapy in combination with bevacizumab in the treatment of unresectable liver metastases in patients with colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LC Beads loaded with Irinotecan and FOLFOX6 | Experimental | Device: LC beads loaded with Irinotecan, Drug: Oxaliplatin, Drug: Leucovorin, Drug: 5-Fluorouracil, Drug: BevacizumabDevice: LC Beads loaded with 100mg Irinotecan Drug: Systemic Chemotherapy (FOLFOX6) Oxaliplatin 85 mg/sqm, IV infusion every two weeks Leucovorin 200mg/sqm, IV infusion every two weeks 5-Fluorouracil 2400mg/sqm, IV infusion every two weeks Bevacizumab 5mg/kg given at the discretion of treating physician |
| FOLFOX6 and Bevacizumab | Active comparator | Drug: Oxaliplatin, Drug: Leucovorin, Drug: 5-Fluorouracil, Drug: BevacizumabDrug: Systemic Chemotherapy (FOLFOX6) Oxaliplatin 85 mg/sqm, IV infusion every two weeks Leucovorin 200mg/sqm, IV infusion every two weeks 5-Fluorouracil 2400mg/sqm, IV infusion every two weeks Bevacizumab 5mg/kg given at the discretion of treating physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients over 18 years of age, of any race or sex, who have histologic or radiologic proof of colorectal cancer to the liver, who are able to give informed consent, will be eligible.
- Patients with at least one measurable liver metastases, with size > 1cm response evaluation criteria in solid tumors (RECIST)
- Patients with liver dominant disease defined as ≥80% tumor body burden confined to the liver
- Patients with patent main portal vein
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of < 2
Key exclusion criteria (13 listed)
- "Any patient eligible for curative treatment (i.e. resection or radiofrequency ablation). Note: resectability is defined as a single tumor <5cm with adequate liver function defined: Total bilirubin ≤ 2.0mg/dl" non-resectability includes patients with greater than 6, tumors close to blood vessels, patients with hepatic-pulmonary shunting, or patients of poor performance"
- Active bacterial, viral or fungal infection within 72 hours of study entry
- Women who are pregnant or breast feeding
- Allergy to contrast media that cannot be managed with standard care (e.g. steroids), making magnetic resonance imaging (MRI) or computed tomography (CT) contraindicated.
- Presence of another malignancy with the exception of cervical carcinoma in situ and stage I basal or squamous carcinoma of the skin.
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 |
|---|---|---|
| LC beads loaded with IrinotecanAlso: LC Beads, TACEChemoembolization using LC beads loaded with 100mg Irinotecan | Device | LC Beads loaded with Irinotecan and FOLFOX6 |
| OxaliplatinAlso: FOLFOX6Oxaliplatin 85 mg/sqm, IV infusion every two weeks | Drug | FOLFOX6 and Bevacizumab, LC Beads loaded with Irinotecan and FOLFOX6 |
| LeucovorinAlso: FOLFOX6Leucovorin 200 mg/sqm, IV infusion every two weeks | Drug | FOLFOX6 and Bevacizumab, LC Beads loaded with Irinotecan and FOLFOX6 |
| 5-FluorouracilAlso: FOLFOX65-Fluorouracil 2400 mg/sqm, IV infusion every 2 week | Drug | FOLFOX6 and Bevacizumab, LC Beads loaded with Irinotecan and FOLFOX6 |
| BevacizumabAlso: AvastinBevacizumab 5 mg/kg given at the discretion of the treating physician | Drug | FOLFOX6 and Bevacizumab, LC Beads loaded with Irinotecan and FOLFOX6 |
Primary outcome
Tumor Response
Time frame: Months 2, 4 and 6
Tumor response will be determined using Modified Response Evaluation Criteria in Solid Tumors (mRECIST). Response will classified as: Complete response - disappearance of all lesions; Partial response - at least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter or 30% reduction of arterial enhancement; Progressive disease - at least 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest longest diameter recorded since start of treatment or appearance of one or more new lesions greater than 1cm in size; Stable disease - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since start of treatment.
1 secondary outcome
Number of Serious Adverse Events
Time frame: First treatment through one year post treatment completion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Robert CG Martin, MD, PhD study director
University of Louisville
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LC beads loaded with Irinotecan, Oxaliplatin and Leucovorin in people with Colon Cancer With Metastases to the Liver, run by University of Louisville at 10 sites in 2 countries.
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 15 inclusion and 13 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 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Argentina. 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 combined 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.
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 7 May 2021). 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?
Tumor Response (time frame: Months 2, 4 and 6). 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 11 Jun 2021.