Status:
ACTIVE_NOT_RECRUITING
Evaluation of the Efficacy and the Safety of FOLFIRINOX3 Bevacizumab Treatment in Patients With Colorectal Cancer (FOLFIRINOX 3)
Lead Sponsor:
Centre Georges Francois Leclerc
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 ...
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 FOL...
Eligibility Criteria
Inclusion
- 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
- 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),
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
November 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 16 2025
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03795311
Start Date
November 7 2018
End Date
July 16 2025
Last Update
February 17 2025
Active Locations (1)
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1
Centre Georges François Leclerc
Dijon, France, 21000