Colorectal CancerPhase 1/2FOLFIRINOX3NCT03795311
Evaluation of the Efficacy and the Safety of FOLFIRINOX3 Bevacizumab Treatment in Patients With Colorectal Cancer (FOLFIRINOX 3)
A Phase 1/2 study testing FOLFIRINOX Bevacizumab in people with Colorectal Cancer, run by Centre Georges Francois Leclerc at 1 site in France.
Trial summary
In patients in progression after oxaliplatin and irinotecan, the study FOLFIRINOX 3 proposes to evaluate the interest of modifying the standard pattern of administration of the molecule of irinotecan in order to make it more efficient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- FOLFIRINOX Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 7 Nov 2018to 16 Jul 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Men or women
- Age ≥ 18 years
- Performance status of 0 or 1 (WHO ECOG Index)
- Patient with metastatic colon cancer
- History of chemotherapy treatment including oxaliplatin, irinotecan, antiangiogenic (bevacizumab or aflibercept) and anti-EGFR if indicated
- Patient eligible for treatment with FOLFIRINOX bevacizumab
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- Tumor evaluation (thoraco-abdominopelvic CT scan) performed within 4 weeks before inclusion with at least one measurable lesion according to RECIST criteria 1.1
- Patient able and able to abide by the protocol throughout the study, including treatment, visits, scheduled examinations and follow-up.
- Biological values within the following limits:
- Bilirubinemia ≤ 1.5 times the upper limit of normal (N)
- ASAT and ALAT ≤ 5 N
- Creatinine ≤ 1.5 N and creatinine clearance> 60 mlmin
- Neutrophils ≥ 1.5. 109 / L
- Platelets ≥ 150. 109 / L
- Hemoglobin ≥ 9 g / dL (patients can be included even if they have been transfused).
- Albuminémie≥30g / L
- Hepatitis B, C and HIV negative serologies
- Information note given and signed informed consent
- Patient affiliated to a social security scheme
- Women must have effective contraception and must have a negative pregnancy test at the time of entry into the study or must no longer be of childbearing age (ie, postmenopausal, after 60 years and no menstruation for ≥1 year without any other medical cause, OR history of hysterectomy, OR history of bilateral oophorectomy),
Who cannot join
- Other cancer in the 5 years prior to entry into the trial or concomitant (except in situ cancer of the cervix or basal cell carcinoma of the skin).
- Presence of cerebral metastasis (s)
- Prognosis estimated <3 months
- Presence of a contraindication to bevacizumab (major surgery in the previous 28 days, risk of arterial thrombosis, risk of haemorrhage, deep vein thrombosis without effective anticoagulant therapy or unbalanced anticoagulant therapy)
- History of grade 4 toxicity to oxaliplatin, irinotecan, 5FU or bevacizumab
- Persistence of neuropathy greater than a grade 1
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- Hypersensitivity to one of the compounds of the treatments
- Participation in course or within 30 days prior to entry into the study to another therapeutic trial with an experimental molecule.
- Demonstration of a DPYD and / or UGT1A1 mutation
- Unbalanced serious illness, underlying infection that may prevent the patient from receiving treatment
- Pregnancy (compulsory pregnancy test at baseline), breastfeeding or lack of effective contraception for men and women of childbearing age
- Psychiatric illness compromising understanding of information or completion of study
- Patient under tutorship, curatorship or court of justice
- Inability to sign informed consent or to undergo medical follow-up of the trial for geographical, social or psychological reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I / II Study Evaluating the Efficacy and Safety of FOLFIRINOX3 Bevacizumab Treatment in Patients With Colorectal Cancer Who Have Failed With Standard Chemotherapy Protocols (FOLFIRINOX 3)
In patients in progression after oxaliplatin and irinotecan, the study FOLFIRINOX 3 proposes to evaluate the interest of modifying the standard pattern of administration of the molecule of irinotecan in order to make it more efficient. In combination with other chemotherapy drugs (5-fluorouracil, oxaliplatin, folinic acid and bevacizumab), irinotecan will be administered at the beginning and end of each cycle of chemotherapy, whereas it is normally administered at one time in the regimen. standard of treatment.
The hypothesis of this study is an increase in the objective response rate at 2 months of 10 to 30% with a scheme by FOLFIRINOX3 - bevacizumab compared to an optimal treatment to date by FOLFIRINOX-bevacizumab.
Read the detailed description
Primary objective
- Main objective of phase I: To evaluate the acute toxicity of treatment with FOLFIRINOX 3 - bevacizumab
- Main objective of phase II: To evaluate the efficacy of treatment with FOLFIRINOX 3 - bevacizumab in terms of objective response according to the RECIST criteria.
Secondary objectives
- To evaluate the efficacy of treatment with FOLFIRINOX 3 - bevacizumab in terms of objective response according to the criteria of CHOI, progression-free survival (PFS) and overall survival (OS)
- To evaluate the late toxicity of treatment with FOLFIRINOX 3 - bevacizumab
- Evaluate the quality of life
- Conditions
- Colorectal Cancer
- Being tested
- FOLFIRINOX Bevacizumab
- Keywords
- FOLFIRINOX3 Bevacizumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFIRINOX BevacizumabDrug
In phase 1, the goal is to define the DLT (maximum tolerated dose). 3 levels of doses will be evaluated with a different dose of irinotecan in each level.
- Level -1: Bevacizumab + Oxaliplatine + Acide folinique + Irinotecan: 60mg / m2
- Level 0: Bevacizumab + Oxaliplatine + Acide folinique +Irinotecan: 70mg / m2
- Level 1: Bevacizumab + Oxaliplatine + Acide folinique +Irinotecan: 90mg / m2
The inclusion of patients will start at level 0. Dose-limiting toxicities will be identified during the first 2 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Administration of chemotherapy molecules | Experimental | The treatment period is divided into 15-day periods.
Schema of the administration to the treatments which will proceed in the same way with each cycle:
Bevacizumab (5 mg/kg; during 30 min) + Oxaliplatine (85 mg/m2, during 2 hours) + Acide folinique (400 mg/m2) or Levofolinate de calcium (200 mg/m2) AND Irinotecan (during 2 hours) + 5-fluorouracile (2400 mg/m2 ; 46 hours) + Irinotecan (1 hour) Receives: Drug: FOLFIRINOX Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Acute toxicities as a Measure of treatment specific Safety and Tolerability
Acute toxicities will be assessed according to the NCI CTCAE v4.03
Measured: each chemotherapy cycle (15 days) up to progression (6 months on average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start7 Nov 2018
- Primary completion16 Jan 2023
- Study completion16 Jul 2025 (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 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795311
- Sponsor's protocol ID
- FOLFIRINOX3
- Acronym
- FOLFIRINOX3
- Status last verified
- Feb 2025
- First submitted
- 2 Jan 2019
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bellio H, Roussot N, Bertaut A, Hervieu A, Zanetta S, Tharin Z, Vincent J, Bengrine L, Hennequin A, Guion JF, Boudrant A, Collot T, Ghiringhelli F, Fumet JD. FOLFIRINOX-3 plus bevacizumab (bFOLFIRINOX3) in chemo-refractory metastatic colorectal cancer: a multicenter phase II trial. Future Oncol. 2025 Mar;21(6):699-706. doi: 10.1080/14796694.2025.2461446. Epub 2025 Feb 6.
PubMed 39913183
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I / II Study Evaluating the Efficacy and Safety of FOLFIRINOX3 Bevacizumab Treatment in Patients With Colorectal Cancer Who Have Failed With Standard Chemotherapy Protocols (FOLFIRINOX 3)
- ClinicalTrials.gov ID
- NCT03795311
- Acronym / sponsor ID
- FOLFIRINOX3 / FOLFIRINOX3
- Conditions
- Colorectal Cancer
- Keywords
- FOLFIRINOX3 Bevacizumab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 16 Jan 2023 (actual)
- Study completion
- 16 Jul 2025 (estimated)
- First posted
- 7 Jan 2019 (actual)
- 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.
In patients in progression after oxaliplatin and irinotecan, the study FOLFIRINOX 3 proposes to evaluate the interest of modifying the standard pattern of administration of the molecule of irinotecan in order to make it more efficient. In combination with other chemotherapy drugs (5-fluorouracil, oxaliplatin, folinic acid and bevacizumab), irinotecan will be administered at the beginning and end of each cycle of chemotherapy, whereas it is normally administered at one time in the regimen. standard of treatment.
The hypothesis of this study is an increase in the objective response rate at 2 months of 10 to 30% with a scheme by FOLFIRINOX3 - bevacizumab compared to an optimal treatment to date by FOLFIRINOX-bevacizumab.
Detailed description
Primary objective
- Main objective of phase I: To evaluate the acute toxicity of treatment with FOLFIRINOX 3 - bevacizumab
- Main objective of phase II: To evaluate the efficacy of treatment with FOLFIRINOX 3 - bevacizumab in terms of objective response according to the RECIST criteria.
Secondary objectives
- To evaluate the efficacy of treatment with FOLFIRINOX 3 - bevacizumab in terms of objective response according to the criteria of CHOI, progression-free survival (PFS) and overall survival (OS)
- To evaluate the late toxicity of treatment with FOLFIRINOX 3 - bevacizumab
- Evaluate the quality of life
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Administration of chemotherapy molecules | Experimental | Drug: FOLFIRINOX BevacizumabThe treatment period is divided into 15-day periods. Schema of the administration to the treatments which will proceed in the same way with each cycle: Bevacizumab (5 mg/kg; during 30 min) + Oxaliplatine (85 mg/m2, during 2 hours) + Acide folinique (400 mg/m2) or Levofolinate de calcium (200 mg/m2) AND Irinotecan (during 2 hours) + 5-fluorouracile (2400 mg/m2 ; 46 hours) + Irinotecan (1 hour) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Men or women
- Age ≥ 18 years
- Performance status of 0 or 1 (WHO ECOG Index)
- Patient with metastatic colon cancer
- History of chemotherapy treatment including oxaliplatin, irinotecan, antiangiogenic (bevacizumab or aflibercept) and anti-EGFR if indicated
Key exclusion criteria (14 listed)
- Other cancer in the 5 years prior to entry into the trial or concomitant (except in situ cancer of the cervix or basal cell carcinoma of the skin).
- Presence of cerebral metastasis (s)
- Prognosis estimated <3 months
- Presence of a contraindication to bevacizumab (major surgery in the previous 28 days, risk of arterial thrombosis, risk of haemorrhage, deep vein thrombosis without effective anticoagulant therapy or unbalanced anticoagulant therapy)
- History of grade 4 toxicity to oxaliplatin, irinotecan, 5FU or bevacizumab
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 |
|---|---|---|
| FOLFIRINOX BevacizumabIn phase 1, the goal is to define the DLT (maximum tolerated dose). 3 levels of doses will be evaluated with a different dose of irinotecan in each level. * Level -1: Bevacizumab + Oxaliplatine + Acide folinique + Irinotecan: 60mg / m2 * Level 0: Bevacizumab + Oxaliplatine + Acide folinique +Irinotecan: 70mg / m2 * Level 1: Bevacizumab + Oxaliplatine + Acide folinique +Irinotecan: 90mg / m2 The inclusion of patients will start at level 0. Dose-limiting toxicities will be identified during the first 2 cycles. | Drug | Administration of chemotherapy molecules |
Primary outcome
Number of Participants with Acute toxicities as a Measure of treatment specific Safety and Tolerability
Time frame: each chemotherapy cycle (15 days) up to progression (6 months on average)
Acute toxicities will be assessed according to the NCI CTCAE v4.03
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Derived from this study: PubMed 39913183Bellio H, Roussot N, Bertaut A, Hervieu A, Zanetta S, Tharin Z, Vincent J, Bengrine L, Hennequin A, Guion JF, Boudrant A, Collot T, Ghiringhelli F, Fumet JD. FOLFIRINOX-3 plus bevacizumab (bFOLFIRINOX3) in chemo-refractory metastatic colorectal cancer: a multicenter phase II trial. Future Oncol. 2025 Mar;21(6):699-706. doi: 10.1080/14796694.2025.2461446. Epub 2025 Feb 6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FOLFIRINOX Bevacizumab in people with Colorectal Cancer, run by Centre Georges Francois Leclerc at 1 site in France.
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 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: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2025. 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of Participants with Acute toxicities as a Measure of treatment specific Safety and Tolerability (time frame: each chemotherapy cycle (15 days) up to progression (6 months on average)). 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 NCT03795311, 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 17 Feb 2025.