Metastatic Colorectal CancerPhase 2ChimeNCT02216487
Trial of FOLF(HA)Iri With Cetuximab in mCRC
A Phase 2 study testing HA-Irinotecan in people with Metastatic Colorectal Cancer, run by Western General Hospital, Australia at 3 sites in Australia.
Trial summary
As an approach to improve efficacy and provide clinical benefit to cancer patients undergoing chemotherapeutic treatment regimens, Alchemia Oncology has developed a novel means for delivering anti-cancer agents to tumours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- HA-Irinotecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesAustralia
- Study dates
- Jun 2014to Nov 2016
- 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
- Tumour is KRAS wild type
- mCRC with disease progression after first-line chemotherapy (adjuvant chemotherapy is considered first line chemotherapy if metastatic progression occurs within 6 months of the end of the adjuvant chemotherapy).
- Irinotecan naïve
- Prior use of bevacizumab in the 1st line setting is permitted.
- ECOG 0 or 1
- Measurable disease
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- Histological proof of colorectal adenocarcinoma
- 18+ years of age
- Adequately recovered from and at least 4 weeks after recent major surgery or chemotherapy
- At least 4 weeks after treatment with a biologic monotherapy from last dose to enrolment.
- Hematology done within 14 days prior to enrolment :
- Absolute Neutrophil count (ANC) greater than 1.5 x 109/L
- Platelets greater than 100 x 109/L
- Hemoglobin greater than or equal to 100g/L
- Chemistry done within 14 days prior to enrolment:
- AST greater than or equal to 2.5 X ULN (greater than 5 X ULN if elevation thought to be related to hepatic metastatic disease),
- Alkaline phosphatase greater than 5 x ULN,
- Serum creatinine greater than 1.5 x ULN,
- Total bilirubin greater than 34.2 µmol/L,
- Negative serum or urine pregnancy test if a WOCBP.
Who cannot join
- KRAS mutant.
- Prior irinotecan
- Prior anti-EGFR
- History of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for greater than 5 years.
- Locally advanced or recurrent disease only
- Unsuitability for irinotecan
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- Abdominal or pelvic radiation therapy (including treatment with SIR-Spheres/Sirtex) within the last 12 months.
- Women who are pregnant or breastfeeding.
- Significant cardiac disease
- Untreated or symptomatic brain or central nervous system (CNS) metastases
- Presence of pleural effusion or ascites requiring therapeutic thoracocentesis or paracentesis.
- Current partial or complete bowel obstruction.
- Concomitant active infection.
Trial locations and contacts
3 sites in 1 country.
Peter Gibbs, MD contact
Australia3 sites, 3 recruiting
- Recruiting
Western General Hospital
Melbourne, Victoria, 3021
Peter Gibbs, MD, Peter.Gibbs@mh.org.au
Peter Gibbs, MD
- Not yet recruiting
Liverpool Hospital
Sydney, New South Wales, 1871
Weng Ng, MD
- Not yet recruiting
Southern Medical Day Care Centre
Wollongong, New South Wales, 2500
Philip Clingan, MD
About this study
Official title: Phase II Single Arm Trial of FOLF(HA)Iri Plus Cetuximab in Irinotecan-naïve Second Line Patients With KRAS Wild Type Metastatic Colorectal Cancer
As an approach to improve efficacy and provide clinical benefit to cancer patients undergoing chemotherapeutic treatment regimens, Alchemia Oncology has developed a novel means for delivering anti-cancer agents to tumours. The drug delivery platform is based on the use of hyaluronic acid (HA), a novel excipient, in which, formulation with HA results in optimisation of cytotoxic drug uptake and retention within solid tumours. In the specific example of HA-Irinotecan, this new formulation of irinotecan has demonstrated enhanced efficacy in both nonclinical and early clinical studies.
The current study is an investigation into the use of HA-Irinotecan in a Phase II single arm trial of FOLF(HA)iri plus cetuximab in irinotecan-naïve second line patients with KRAS wild type metastatic colorectal cancer. The study objectives are to confirm the safety and efficacy of FOLF(HA)iri plus cetuximab as second-line therapy in irinotecan-naïve metastatic colorectal cancer patients.
It is expected that the study recruit approximately 40-50 patients in 1 year with subsequent treatment and follow up; thus the trial will run for approximately 2-3 years.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- HA-Irinotecan
- Keywords
- mCRC, 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.
HA-IrinotecanDrug
HA-Irinotecan is administered as part of FOLFIRI/cetuximab treatment in place of irinotecan for treatment of mCRC.
| Study group | Role | What they receive |
|---|---|---|
| HA-Irinotecan | Experimental | HA-Irinotecan is administered as part of FOLFIRI/cetuximab treatment in place of irinotecan. Receives: Drug: HA-Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
To assess FOLF(HA)iri plus cetuximab with respect to:
Patient safety, including incidence of severe (Grade 3/4) toxicity according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western General Hospital, Australia
- Sponsor type
- University, hospital or other
- Collaborators
- Alchemia Oncology, Merck Serono International SA
- Responsible party
- Principal investigator, Peter Gibbs, Western Hospital, Australia
- Investigators
- Peter Gibbs, MD, Principal investigator, Western General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216487
- Sponsor's protocol ID
- ACO-004
- Acronym
- Chime
- Status last verified
- Aug 2014
- First submitted
- 12 Aug 2014
- Last updated
- 29 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Single Arm Trial of FOLF(HA)Iri Plus Cetuximab in Irinotecan-naïve Second Line Patients With KRAS Wild Type Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02216487
- Acronym / sponsor ID
- Chime / ACO-004
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- mCRC, colorectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Western General Hospital, AustraliaUniversity, hospital or other
- Collaborators
- Alchemia Oncology, Merck Serono International SA
- Study start
- Jun 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 15 Aug 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.
As an approach to improve efficacy and provide clinical benefit to cancer patients undergoing chemotherapeutic treatment regimens, Alchemia Oncology has developed a novel means for delivering anti-cancer agents to tumours. The drug delivery platform is based on the use of hyaluronic acid (HA), a novel excipient, in which, formulation with HA results in optimisation of cytotoxic drug uptake and retention within solid tumours. In the specific example of HA-Irinotecan, this new formulation of irinotecan has demonstrated enhanced efficacy in both nonclinical and early clinical studies.
The current study is an investigation into the use of HA-Irinotecan in a Phase II single arm trial of FOLF(HA)iri plus cetuximab in irinotecan-naïve second line patients with KRAS wild type metastatic colorectal cancer. The study objectives are to confirm the safety and efficacy of FOLF(HA)iri plus cetuximab as second-line therapy in irinotecan-naïve metastatic colorectal cancer patients.
It is expected that the study recruit approximately 40-50 patients in 1 year with subsequent treatment and follow up; thus the trial will run for approximately 2-3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HA-Irinotecan | Experimental | Drug: HA-IrinotecanHA-Irinotecan is administered as part of FOLFIRI/cetuximab treatment in place of irinotecan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Tumour is KRAS wild type
- mCRC with disease progression after first-line chemotherapy (adjuvant chemotherapy is considered first line chemotherapy if metastatic progression occurs within 6 months of the end of the adjuvant chemotherapy).
- Irinotecan naïve
- Prior use of bevacizumab in the 1st line setting is permitted.
- ECOG 0 or 1
Key exclusion criteria (13 listed)
- KRAS mutant.
- Prior irinotecan
- Prior anti-EGFR
- History of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for greater than 5 years.
- Locally advanced or recurrent disease only
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 |
|---|---|---|
| HA-IrinotecanHA-Irinotecan is administered as part of FOLFIRI/cetuximab treatment in place of irinotecan for treatment of mCRC. | Drug | HA-Irinotecan |
Primary outcome
Safety
Time frame: 2 years
To assess FOLF(HA)iri plus cetuximab with respect to: Patient safety, including incidence of severe (Grade 3/4) toxicity according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 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.
Peter Gibbs, MD contact
Peter Gibbs, MD principal investigator
Western General Hospital
3 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 HA-Irinotecan in people with Metastatic Colorectal Cancer, run by Western General Hospital, Australia at 3 sites in Australia.
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 20 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: status not confirmed, as of the sponsor's last update on 29 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Gibbs, MD (Peter.Gibbs@mh.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 2 years). 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 29 Aug 2014.