Metastatic Colorectal CancerPhase 3FOLF(HA)iriNCT01290783
Trial of FOLF(HA)Iri Versus FOLFIRI in mCRC
A Phase 3 study testing Irintoecan and HA-Irinotecan solution for Infusion in people with Metastatic Colorectal Cancer, run by Alchemia Oncology at 5 sites in Australia.
Trial summary
Trial design: Phase III, FOLFIRI versus FOLF(HA)iri (the FOLFIRI regimen with "Hyaluronic acid-Irinotecan" or "HA-Irinotecan") regimen. Patients with mCRC (metastatic colorectal cancer), 2nd/3rd line irinotecan naïve. 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?
- Irintoecan and HA-Irinotecan solution for Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 5 sitesAustralia
- Study dates
- Dec 2011to Dec 2015
- Phase
- Phase 3
- 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
- Metastatic colorectal cancer with disease progression after first or second line chemotherapy
- Irinotecan naïve.
- ECOG performance status of 0 or 1.
- Measurable disease, i.e. at least one measurable metastatic lesion (spiral CT or MRI).
- Histological proof of colorectal cancer.
- 18 years of age and older.
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- Adequately recovered from and at least 4 weeks after recent surgery or chemotherapy.
- Women of child-bearing potential (WOCBP) and male partners of WOCBP must agree to use adequate contraception.
- Patient consent obtained and signed according to local and/or national ethics.
- CT or MRI scan of chest/abdomen/pelvis within 21 days prior to randomization.
- Hematology done within 14 days prior to randomization.
- Chemistry done within 14 days prior to randomization.
Who cannot join
- History of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for > 5 years.
- Locally advanced or recurrent disease only.
- Unsuitability for irinotecan including known Gilbert's syndrome, active inflammatory bowel disease or chronic diarrhea greater than or equal to grade 2.
- Abdominal or pelvic radiation therapy within the last 12 months.
- Women who are pregnant or breastfeeding.
- Any condition (e.g., psychological, geographical) that would render the protocol treatment dangerous.
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- Significant cardiac disease.
- Untreated or symptomatic brain or central nervous system (CNS).
- Presence of pleural effusion or ascites requiring therapeutic thoracocentesis or paracentesis.
- Current partial or complete bowel obstruction.
- Concomitant active infection.
- Enrolled in any other investigational trial, unless treatment in that trial has been discontinued at least 30 days prior to signing the Informed Consent for the ACO-002 study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Australia5 sites
Western General Hospital
Melbourne, Victoria, 3011
Royal Melbourne Hospital
Melbourne, Victoria, 3050
Monash Medical Centre
Melbourne, Victoria, 3165
Border Medical Oncology
Wodonga, Victoria, 3690
Southern Medical Day Care Centre
Wollongong, New South Wales, 2500
About this study
Official title: Randomized Double-blind Phase III Trial of FOLF(HA)Iri vs FOLFIRI for Second or Third Line Therapy in Irinotecan-naïve Patients With Metastatic Colorectal Cancer
Trial design:
- Phase III, FOLFIRI versus FOLF(HA)iri (the FOLFIRI regimen with "Hyaluronic acid-Irinotecan" or "HA-Irinotecan") regimen.
- Patients with mCRC (metastatic colorectal cancer), 2nd/3rd line irinotecan naïve.
- Randomized 1:1, double-blinded, multi-centre, multi-national (Australia, Bulgaria, Poland, Serbia, Russia, Ukraine and the United Kingdom).
- Dosing regimen:
- Irinotecan (180 mg/m2) or HA-Irinotecan (180 mg/m2), IV, over 90 minutes, day 1 (in patients > 75 years of age, the irinotecan and HA-Irinotecan dose in must be reduced to 150 mg/m2).
- Leucovorin, 400 mg/m2, or levoleucovorin, 200 mg/m2, IV over 90 minutes with irinotecan.
- 5-fluorouracil (5-FU), 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion.
- Repeat every 2 weeks for 8 months.
- Patient accrual over approximately 12-14 months.
- Monitoring to 18 months post-randomization.
- 390 patients.
- Progression Free Survival (PFS) primary endpoint.
- Safety analysis on the initial 20 patients.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Irintoecan, HA-Irinotecan solution for Infusion
- Keywords
- mCRC, CRC, colorectal, irinotecan, Hyaluronic acid, Hyaluronan
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrintoecanDrug
- Irinotecan, 180 mg/m2 IV, over 90 minutes, day 1 (in patients > 75 years of age, the irinotecan dose in must be reduced to 150 mg/m2).
- Leucovorin, 400 mg/m2, or levoleucovorin, 200 mg/m2, IV over 90 minutes with irinotecan.
- 5-FU, 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion.
- Repeat every two weeks.
- 8 months of treatment.
HA-Irinotecan solution for InfusionDrug
- HA-Irinotecan (irinotecan 180 mg/m2), IV, over 90 minutes, day 1 (in patients > 75 years of age, the irinotecan dose in must be reduced to 150 mg/m2).
- Leucovorin, 400 mg/m2, or levoleucovorin, 200 mg/m2, IV over 90 minutes with irinotecan.
- 5-FU, 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion.
- Repeat every two weeks
- 8 months of treatment.
| Study group | Role | What they receive |
|---|---|---|
| FOLFIRI | Active comparator | Not described Receives: Drug: Irintoecan |
| FOLF(HA)iri | Experimental | Not described Receives: Drug: HA-Irinotecan solution for Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Measured: Approximately 20 months
Secondary outcomes (1)
Safety
Diarrhea and haematology
Measured: After initial 20 patients receive 2 cycles, then 6 monthly thereafter.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2011 (estimated)
- Study startDec 2011
- Primary completionOct 2014
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alchemia Oncology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Gibbs, MD, Principal investigator, Melbourne Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290783
- Sponsor's protocol ID
- ACO-002
- Acronym
- FOLF(HA)iri
- Status last verified
- Aug 2014
- First submitted
- 31 Jan 2011
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gibbs P, Clingan PR, Ganju V, Strickland AH, Wong SS, Tebbutt NC, Underhill CR, Fox RM, Clavant SP, Leung J, Pho M, Brown TJ. Hyaluronan-Irinotecan improves progression-free survival in 5-fluorouracil refractory patients with metastatic colorectal cancer: a randomized phase II trial. Cancer Chemother Pharmacol. 2011 Jan;67(1):153-63. doi: 10.1007/s00280-010-1303-3. Epub 2010 Mar 24.
PubMed 20333384
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Phase III Trial of FOLF(HA)Iri vs FOLFIRI for Second or Third Line Therapy in Irinotecan-naïve Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01290783
- Acronym / sponsor ID
- FOLF(HA)iri / ACO-002
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- mCRC, CRC, colorectal, irinotecan, Hyaluronic acid, Hyaluronan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Alchemia OncologyIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 7 Feb 2011 (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.
Trial design:
- Phase III, FOLFIRI versus FOLF(HA)iri (the FOLFIRI regimen with "Hyaluronic acid-Irinotecan" or "HA-Irinotecan") regimen.
- Patients with mCRC (metastatic colorectal cancer), 2nd/3rd line irinotecan naïve.
- Randomized 1:1, double-blinded, multi-centre, multi-national (Australia, Bulgaria, Poland, Serbia, Russia, Ukraine and the United Kingdom).
- Dosing regimen:
- Irinotecan (180 mg/m2) or HA-Irinotecan (180 mg/m2), IV, over 90 minutes, day 1 (in patients > 75 years of age, the irinotecan and HA-Irinotecan dose in must be reduced to 150 mg/m2).
- Leucovorin, 400 mg/m2, or levoleucovorin, 200 mg/m2, IV over 90 minutes with irinotecan.
- 5-fluorouracil (5-FU), 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion.
- Repeat every 2 weeks for 8 months.
- Patient accrual over approximately 12-14 months.
- Monitoring to 18 months post-randomization.
- 390 patients.
- Progression Free Survival (PFS) primary endpoint.
- Safety analysis on the initial 20 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOLFIRI | Active comparator | Drug: Irintoecan |
| FOLF(HA)iri | Experimental | Drug: HA-Irinotecan solution for Infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Metastatic colorectal cancer with disease progression after first or second line chemotherapy
- Irinotecan naïve.
- ECOG performance status of 0 or 1.
- Measurable disease, i.e. at least one measurable metastatic lesion (spiral CT or MRI).
- Histological proof of colorectal cancer.
Key exclusion criteria (12 listed)
- History of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for > 5 years.
- Locally advanced or recurrent disease only.
- Unsuitability for irinotecan including known Gilbert's syndrome, active inflammatory bowel disease or chronic diarrhea greater than or equal to grade 2.
- Abdominal or pelvic radiation therapy within the last 12 months.
- Women who are pregnant or breastfeeding.
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 |
|---|---|---|
| Irintoecan* Irinotecan, 180 mg/m2 IV, over 90 minutes, day 1 (in patients > 75 years of age, the irinotecan dose in must be reduced to 150 mg/m2). * Leucovorin, 400 mg/m2, or levoleucovorin, 200 mg/m2, IV over 90 minutes with irinotecan. * 5-FU, 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion. * Repeat every two weeks. * 8 months of treatment. | Drug | FOLFIRI |
| HA-Irinotecan solution for Infusion* HA-Irinotecan (irinotecan 180 mg/m2), IV, over 90 minutes, day 1 (in patients > 75 years of age, the irinotecan dose in must be reduced to 150 mg/m2). * Leucovorin, 400 mg/m2, or levoleucovorin, 200 mg/m2, IV over 90 minutes with irinotecan. * 5-FU, 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion. * Repeat every two weeks * 8 months of treatment. | Drug | FOLF(HA)iri |
Primary outcome
Progression Free Survival (PFS)
Time frame: Approximately 20 months
1 secondary outcome
Safety
Time frame: After initial 20 patients receive 2 cycles, then 6 monthly thereafter.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2015.
- Background: PubMed 20333384Gibbs P, Clingan PR, Ganju V, Strickland AH, Wong SS, Tebbutt NC, Underhill CR, Fox RM, Clavant SP, Leung J, Pho M, Brown TJ. Hyaluronan-Irinotecan improves progression-free survival in 5-fluorouracil refractory patients with metastatic colorectal cancer: a randomized phase II trial. Cancer Chemother Pharmacol. 2011 Jan;67(1):153-63. doi: 10.1007/s00280-010-1303-3. Epub 2010 Mar 24.
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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 principal investigator
Melbourne Health
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Irintoecan and HA-Irinotecan solution for Infusion in people with Metastatic Colorectal Cancer, run by Alchemia Oncology at 5 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 12 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: status not confirmed, as of the sponsor's last update on 29 Apr 2015. 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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 (PFS) (time frame: Approximately 20 months). 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 NCT01290783, which also lists 1 linked publication.
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 Apr 2015.