Evaluation of the Efficacy and the Safety of FOLFIRINOX3 Bevacizumab Treatment in Patients With Colorectal Cancer (FOLFIRINOX 3)

Program Status

Active, not recruiting

Phase

Phase 1

Prior Immunotherapy Allowed

No

CRC-directed Trial

Yes

Drugs

FOLFIRINOX Bevacizumab

Tags

MSS/ MMRp
Location Location Status
France
Centre Georges François Leclerc
Dijon 21000
Active, not recruiting

Inclusion Criteria

Inclusion Criteria:

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 Criteria

Exclusion Criteria:

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.

NCT ID

NCT03795311

Date Trial Added

2019-01-07

Updated Date

2023-10-17