Metastatic Colorectal CancerPhase 1/2PARAGON-IINCT00844233
Study of Chemoembolisation Using Irinotecan Bead Prior to Surgery in Metastatic Colorectal Cancer
A Phase 1/2 study testing Irinotecan Bead in people with Metastatic Colorectal Cancer, run by Boston Scientific Corporation at 5 sites in 3 countries.
Trial summary
The objective of this study is to evaluate the safety and efficacy of Irinotecan Bead in the neoadjuvant treatment (i.e. the Irinotecan Bead is administered prior to surgery) of resectable liver metastases from colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Irinotecan Bead
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Feb 2009to Oct 2012
- Phase
- Phase 1/2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of potentially resectable colorectal cancer liver metastases, with less than 60% liver tumour replacement. The consulting surgeon, according to local practice, will determine resectability.
- Patients having undergone complete resection of the primary tumour without gross or microscopic evidence of residual disease (R0), or the primary tumour is considered R0 resectable at screening.
- Age: 18-80 years.
- ECOG Status ≤2.
- No previous irinotecan-containing chemotherapy for advanced disease.
- Previous chemotherapy is allowed (unless it contained irinotecan), but must have ended at least one month prior to study entry.
Show all 22Show fewer
- Presence of adequate contraception in fertile (M/F) patients. Pregnant or lactating women are excluded.
- Absence of any other previous malignancy other than adequately treated in situ carcinoma of the cervix or non-melanoma skin cancer (unless there has been a disease-free interval of at least 10 years).
- Patients should not have participated in another clinical trial with any investigational drug in the 30 days prior to enrolment.
- Absence of:
- Peripheral neuropathy (CTC > grade 1)
- Uncontrolled congestive heart failure or angina pectoris, or hypertension or arrhythmia.
- History of significant neurologic or psychiatric disorders
- Active infection
- Written informed consent according to ICH/EU GCP, and any applicable local, national or international regulations.
- Patients with liver-dominant disease, defined as ≥80% of the tumour body burden confined to the liver. Unilobar disease, or bilobar disease suitable for treatment in a single chemoembolisation procedure, with a maximum of 4 lesions.
- Hematologic function: WBC ≥3.0 x 10*9/L, platelets ≥100 x 10*9/L, Absolute neutrophil count > 1.5 x 10*9/l.
- Adequate organ function as measured by:
- Serum creatinine ≤2 x upper limit of normal (ULN).
- Serum transaminases (AST \& ALT) ≤5 x ULN.
- Total bilirubin ≤1.5 x ULN.
- Prothrombin time >50% of normal.
Who cannot join
- Extrahepatic metastases constituting >20% of tumour body burden.
- Contraindications to irinotecan:
- Chronic inflammatory bowel disease and/or bowel obstruction.
- History of severe hypersensitivity reactions to irinotecan hydrochloride trihydrate.
- Severe bone marrow failure.
- Concomitant use with St John's Wort.
Show all 14Show fewer
- Active bacterial, viral or fungal infection within 72 hours of study entry.
- Allergy to contrast media that cannot be managed with standard care.
- Any contraindication for hepatic embolisation procedures:
- porto-systemic shunt.
- hepatofugal blood flow.
- severe atheromatosis.
- Contraindication to hepatic artery catheterisation, such as a patient with severe peripheral vascular disease precluding catheterisation.
- 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 chemoembolisation or would interfere with study participation.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United Kingdom3 sites
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, RG24 9NA
University Hospital Aintree
Liverpool, L9 7AL
North Manchester General Hospital
Manchester, M8 5RB
About this study
Official title: A Single Arm Phase II Study of Neoadjuvant Therapy Using Irinotecan Bead in Patients With Resectable Liver Metastases From Colorectal Cancer
The objective of this study is to evaluate the safety and efficacy of Irinotecan Bead in the neoadjuvant treatment (i.e. the Irinotecan Bead is administered prior to surgery) of resectable liver metastases from colorectal cancer.
Read the detailed description
The Primary Endpoint of this study is Tumour resectability at surgery. Secondary Endpoints:
- Safety assessed by SAE and AE monitoring (NCI CTCAE v3.0)
- Tumour response assessed by imaging (RECIST and necrosis)
- Viable residual tumour assessed by pathological evaluation of resected liver tissue.
- Recurrence (time and site) following resection
- Correlation of tumour response by imaging and pathology
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Irinotecan Bead
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan BeadDevice
Also called Irinotecan Bead, PARAGON Bead
Irinotecan eluting bead
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Irinotecan Bead Receives: Device: Irinotecan Bead |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumour resectability at surgery
Measured: 1 month
Secondary outcomes (1)
Safety assessed by SAE and AE monitoring (NCI CTCAE v3.0)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionSep 2011
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biocompatibles UK Ltd
- Responsible party
- Sponsor
- Investigators
- Professor Graeme Poston, MB, MS, FRCS, Principal investigator, Consultant General Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00844233
- Sponsor's protocol ID
- CA1016
- Acronym
- PARAGON-II
- Status last verified
- Jul 2021
- First submitted
- 9 Feb 2009
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Jones RP, Malik HZ, Fenwick SW, Terlizzo M, O'Grady E, Stremitzer S, Gruenberger T, Rees M, Plant G, Figueras J, Albiol M, Adam R, Awad S, Poston GJ. PARAGON II - A single arm multicentre phase II study of neoadjuvant therapy using irinotecan bead in patients with resectable liver metastases from colorectal cancer. Eur J Surg Oncol. 2016 Dec;42(12):1866-1872. doi: 10.1016/j.ejso.2016.07.142. Epub 2016 Aug 10.
PubMed 27561844Jones RP, Dunne D, Sutton P, Malik HZ, Fenwick SW, Terlizzo M, O'Grady E, Koelblinger C, Stattner S, Stremitzer S, Gruenberger T, Poston GJ. Segmental and lobar administration of drug-eluting beads delivering irinotecan leads to tumour destruction: a case-control series. HPB (Oxford). 2013 Jan;15(1):71-7. doi: 10.1111/j.1477-2574.2012.00587.x. Epub 2012 Oct 16.
PubMed 23216781
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Phase II Study of Neoadjuvant Therapy Using Irinotecan Bead in Patients With Resectable Liver Metastases From Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00844233
- Acronym / sponsor ID
- PARAGON-II / CA1016
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Biocompatibles UK Ltd
- Study start
- Feb 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 16 Feb 2009 (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 objective of this study is to evaluate the safety and efficacy of Irinotecan Bead in the neoadjuvant treatment (i.e. the Irinotecan Bead is administered prior to surgery) of resectable liver metastases from colorectal cancer.
Detailed description
The Primary Endpoint of this study is Tumour resectability at surgery. Secondary Endpoints:
- Safety assessed by SAE and AE monitoring (NCI CTCAE v3.0)
- Tumour response assessed by imaging (RECIST and necrosis)
- Viable residual tumour assessed by pathological evaluation of resected liver tissue.
- Recurrence (time and site) following resection
- Correlation of tumour response by imaging and pathology
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Irinotecan BeadIrinotecan Bead |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Presence of potentially resectable colorectal cancer liver metastases, with less than 60% liver tumour replacement. The consulting surgeon, according to local practice, will determine resectability.
- Patients having undergone complete resection of the primary tumour without gross or microscopic evidence of residual disease (R0), or the primary tumour is considered R0 resectable at screening.
- Age: 18-80 years.
- ECOG Status ≤2.
- No previous irinotecan-containing chemotherapy for advanced disease.
Key exclusion criteria (14 listed)
- Extrahepatic metastases constituting >20% of tumour body burden.
- Contraindications to irinotecan:
- Active bacterial, viral or fungal infection within 72 hours of study entry.
- Allergy to contrast media that cannot be managed with standard care.
- Any contraindication for hepatic embolisation procedures:
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 |
|---|---|---|
| Irinotecan BeadAlso: Irinotecan Bead, PARAGON BeadIrinotecan eluting bead | Device | 1 |
Primary outcome
Tumour resectability at surgery
Time frame: 1 month
1 secondary outcome
Safety assessed by SAE and AE monitoring (NCI CTCAE v3.0)
Time frame: 1 month
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 21 Jul 2021.
- Derived from this study: PubMed 27561844Jones RP, Malik HZ, Fenwick SW, Terlizzo M, O'Grady E, Stremitzer S, Gruenberger T, Rees M, Plant G, Figueras J, Albiol M, Adam R, Awad S, Poston GJ. PARAGON II - A single arm multicentre phase II study of neoadjuvant therapy using irinotecan bead in patients with resectable liver metastases from colorectal cancer. Eur J Surg Oncol. 2016 Dec;42(12):1866-1872. doi: 10.1016/j.ejso.2016.07.142. Epub 2016 Aug 10.
- Derived from this study: PubMed 23216781Jones RP, Dunne D, Sutton P, Malik HZ, Fenwick SW, Terlizzo M, O'Grady E, Koelblinger C, Stattner S, Stremitzer S, Gruenberger T, Poston GJ. Segmental and lobar administration of drug-eluting beads delivering irinotecan leads to tumour destruction: a case-control series. HPB (Oxford). 2013 Jan;15(1):71-7. doi: 10.1111/j.1477-2574.2012.00587.x. Epub 2012 Oct 16.
- Sponsor company websiteLink provided by the sponsor.
Related trials for Metastatic Colorectal Cancer
RecruitingPhase 1/2
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Colorectal Cancer
RecruitingPhase 1
Phase 1 Study Of SAR445877 In Combination With FOLFOX6 And Bevacizumab As First-Line Treatment For Microsatellite Stable Metastatic Colorectal Cancer
Phase 1, SAR445877
RecruitingPhase 1
A Study of [225Ac]Ac-AKY-2519 in Patients With B7-H3 Expressing Solid Tumors
NSCLC, NSCLC (Advanced Non-small Cell Lung Cancer)
RecruitingPhase 1
Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
Advanced Solid Tumors, Metastatic Pancreatic Cancer
Not yet recruitingObservational study
Real-World Treatment Patterns and Effectiveness of Anti-EGFR- and Anti-VEGF-based Therapies in Left-sided RAS Wild-Type Metastatic Colorectal Cancer
Metastatic Colorectal Cancer
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.
Professor Graeme Poston, MB, MS, FRCS principal investigator
Consultant General Surgeon
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Irinotecan Bead in people with Metastatic Colorectal Cancer, run by Boston Scientific Corporation at 5 sites in 3 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 22 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 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom, Austria, France. 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?
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?
Tumour resectability at surgery (time frame: 1 month). 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 NCT00844233, which also lists 2 linked publications.
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 21 Jul 2021.