Colorectal Cancer Liver MetastasesPhase 2COI-BNCT02086656
PERIOPERATIVE TREATMENT WITH COI-B (CAPECITABINE, OXALIPLATIN, IRINOTECAN AND BEVACIZUMAB) OF HIGH RISK OR BORDERLINE RESECTABLE COLORECTAL CANCER LIVER METASTASES
A Phase 2 study testing capecitabine, oxaliplatin, irinotecan and bevacizumab in people with Colorectal Cancer Liver Metastases, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
Trial summary
Capecitabine, oxaliplatin, irinotecan and bevacizumab as perioperative strategy of borderline and/or high risk resectable colorectal cancer liver metastases Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Liver Metastases
- What is being tested?
- capecitabine, oxaliplatin, irinotecan and bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2013to 30 Mar 2017
- 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
- Histological diagnosis of colorectal adenocarcinoma.
- Liver-limited metastases or metastases mainly (≥80% total disease burden) limited to the liver with extrahepatic disease judged resectable concomitantly or sequentially. Primary tumor may be resected or not, but patient must not be symptomatic for T.
- Previous adjuvant therapy is allowed if it had been terminated for at least 6 months.
- Previous first line treatment (irinotecan or oxaliplatin containing regimen) with stable or partial response after no more than 3 months of treatment
- Age >= 18 years
- Performance Status (ECOG <2)
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- Adequate organ function including the following:
- Adequate bone marrow reserve: WBC count >3.0x109/L, absolute neutrophil count >1.5x109/L, platelet count >100x109/L, and hemoglobin >10 g/dL .
- Hepatic: bilirubin < 1.5 times the ULN, alkaline phosphatase, aspartate transaminase, and alanine transaminase < 2.5 xULN
- Renal : serum creatinin <2.0xULN
- Patients compliance and geographic proximity that allows for adequate follow-up
- Patients must sign an informed consent document (ICD)
- Male and female patients with reproductive potential must use an approved contraceptive method.
Who cannot join
- Tumor involvement of liver > 75%
- Chance of a liver remnant after surgery < 25%
- Eligibility for concurrent radiotherapeutic treatment
- Disease progression during first line chemotherapy with FOLFOX, XELOX, FOLFIRI or XELIRI plus bevacizumab
- Previous treatment with more than 3 months of FOLFOX or FOLFIRI
- Previous therapy with bevacizumab or cetuximab or panitumumab
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- Administration of other experimental drugs during the study.
- Body Mass Index > 35
- Brain metastases.
- Pregnancy and breast-feeding.
- Serious or uncontrolled medical pathologies or active infections that would jeopardize the possibility of receiving the investigated treatment. Disorders that could influence the absorption of capecitabine (e.g. malabsorption), intestinal occlusion, Crohn's disease or ulcerative colitis.
- Psychiatric disorders, neurologic disease or other conditions that would make it impossible to comply with the protocol procedures. Peripheral neuropathy not related to oxaliplatin previous administration.
- Previous dangerous life threatening toxicities from fluoropyrimidine.
- Positive anamnesis with regard to other neoplastic diseases except for the ones that have been cured for more than 5 years.
Trial locations and contacts
1 site in 1 country.
About this study
Capecitabine, oxaliplatin, irinotecan and bevacizumab as perioperative strategy of borderline and/or high risk resectable colorectal cancer liver metastases
Read the detailed description
Previous studies demonstrated a significant association between tumor regression grade of hepatic colorectal metastases (TRG1: complete pathological response; TRG2: major pathological response; TRG3: partial pathological response; versus TRG4-5 no pathological response) and outcome in terms of survival after neoadjuvant treatment. In particular, retrospective data showed an association between oxaliplatin-based chemotherapy and improvement of grade and percentage of tumor regression; moreover, the addition of Bevacizumab seems to improve TRG over chemotherapy alone, conferring also a protection against liver damage due to chemotherapy-induced sinusoidal obstruction syndrome.
This is the rationale that induced us to carry out an evaluation and feasibility assessment of a perioperative approach with COI-B regimen in patients affected by high risk or borderline resectable colorectal liver metastases, with or without previous resection of primary tumor.
- Conditions
- Colorectal Cancer Liver Metastases
- Being tested
- capecitabine, oxaliplatin, irinotecan and bevacizumab
- Keywords
- liver metastases, colorectal cancer, perioperative treatment
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabine, oxaliplatin, irinotecan and bevacizumabDrug
perioperative COI-B
| Study group | Role | What they receive |
|---|---|---|
| open label | Experimental | Single arm, open label Receives: Drug: capecitabine, oxaliplatin, irinotecan and bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological response rate
Primary:
- To evaluate the activity of the regimen with regards to major/complete pathological response. Major/complete pathological response is measured by pathologist in terms of tumor regression grade (TRG) as described by Rubbia-Brandt L, Annals of Oncology 2007 (percentage of vial residual cells 0-10%).
Measured: Assessed at the time of surgery of liver metastases (between weeks 17-20 from enrollment)
Secondary outcomes (1)
RECIST Response rate
- Response rate according to RECIST vers. 1.1 criteria
Measured: Available at week 9 after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startJun 2013
- Primary completion30 Mar 2017
- Study completion30 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer Liver MetastasesStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filippo Pietrantonio, M.D., Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Investigators
- Filippo de Braud, MD, Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086656
- Sponsor's protocol ID
- COI-B
- Acronym
- COI-B
- Status last verified
- Aug 2019
- First submitted
- 20 Dec 2013
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PERIOPERATIVE TREATMENT WITH COI-B (CAPECITABINE, OXALIPLATIN, IRINOTECAN AND BEVACIZUMAB) OF HIGH RISK OR BORDERLINE RESECTABLE COLORECTAL CANCER LIVER METASTASES
- ClinicalTrials.gov ID
- NCT02086656
- Acronym / sponsor ID
- COI-B / COI-B
- Conditions
- Colorectal Cancer Liver Metastases
- Keywords
- liver metastases, colorectal cancer, perioperative treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- 30 Mar 2017 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 13 Mar 2014 (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.
Capecitabine, oxaliplatin, irinotecan and bevacizumab as perioperative strategy of borderline and/or high risk resectable colorectal cancer liver metastases
Detailed description
Previous studies demonstrated a significant association between tumor regression grade of hepatic colorectal metastases (TRG1: complete pathological response; TRG2: major pathological response; TRG3: partial pathological response; versus TRG4-5 no pathological response) and outcome in terms of survival after neoadjuvant treatment. In particular, retrospective data showed an association between oxaliplatin-based chemotherapy and improvement of grade and percentage of tumor regression; moreover, the addition of Bevacizumab seems to improve TRG over chemotherapy alone, conferring also a protection against liver damage due to chemotherapy-induced sinusoidal obstruction syndrome.
This is the rationale that induced us to carry out an evaluation and feasibility assessment of a perioperative approach with COI-B regimen in patients affected by high risk or borderline resectable colorectal liver metastases, with or without previous resection of primary tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open label | Experimental | Drug: capecitabine, oxaliplatin, irinotecan and bevacizumabSingle arm, open label |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histological diagnosis of colorectal adenocarcinoma.
- Liver-limited metastases or metastases mainly (≥80% total disease burden) limited to the liver with extrahepatic disease judged resectable concomitantly or sequentially. Primary tumor may be resected or not, but patient must not be symptomatic for T.
- Previous adjuvant therapy is allowed if it had been terminated for at least 6 months.
- Previous first line treatment (irinotecan or oxaliplatin containing regimen) with stable or partial response after no more than 3 months of treatment
- Age >= 18 years
Key exclusion criteria (14 listed)
- Tumor involvement of liver > 75%
- Chance of a liver remnant after surgery < 25%
- Eligibility for concurrent radiotherapeutic treatment
- Disease progression during first line chemotherapy with FOLFOX, XELOX, FOLFIRI or XELIRI plus bevacizumab
- Previous treatment with more than 3 months of FOLFOX or FOLFIRI
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 |
|---|---|---|
| capecitabine, oxaliplatin, irinotecan and bevacizumabperioperative COI-B | Drug | open label |
Primary outcome
Pathological response rate
Time frame: Assessed at the time of surgery of liver metastases (between weeks 17-20 from enrollment)
Primary: - To evaluate the activity of the regimen with regards to major/complete pathological response. Major/complete pathological response is measured by pathologist in terms of tumor regression grade (TRG) as described by Rubbia-Brandt L, Annals of Oncology 2007 (percentage of vial residual cells 0-10%).
1 secondary outcome
RECIST Response rate
Time frame: Available at week 9 after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
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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.
Filippo de Braud, MD principal investigator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing capecitabine, oxaliplatin, irinotecan and bevacizumab in people with Colorectal Cancer Liver Metastases, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
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 13 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: finished, as of the sponsor's last update on 7 Aug 2019. 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 Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pathological response rate (time frame: Assessed at the time of surgery of liver metastases (between weeks 17-20 from enrollment)). 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 7 Aug 2019.