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NCT03795311Active, not recruitingPhase 1/2

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

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)

Source: ClinicalTrials.gov · Last updated 17 Feb 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
32 (actual)
First submitted
2 Jan 2019
Start date
7 Nov 2018
Primary completion date
16 Jan 2023
Lead sponsor
Centre Georges Francois Leclerc
NCT number
NCT03795311
EU CT number
2024-515908-39-00
EudraCT number
2018-001452-36

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 32
  • From 7 Nov 2018 to the primary completion date, 16 Jan 2023
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 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)
  • Participation in course or within 30 days prior to entry into the study to another therapeutic trial with an experimental molecule.
  • Unbalanced serious illness, underlying infection that may prevent the patient from receiving treatment

Other illness

  • History of grade 4 toxicity to oxaliplatin, irinotecan, 5FU or bevacizumab
  • Hypersensitivity to one of the compounds of the treatments
  • Psychiatric illness compromising understanding of information or completion of study

Age

  • Pregnancy (compulsory pregnancy test at baseline), breastfeeding or lack of effective contraception for men and women of childbearing age

Other

  • Presence of cerebral metastasis (s)
  • Prognosis estimated \<3 months
  • Persistence of neuropathy greater than a grade 1
  • Demonstration of a DPYD and / or UGT1A1 mutation
  • 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.

Who the study is looking for

  • 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),

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier William Morey
Coordinator of this site? Confirm its status
Chalon Sur Saone CedexFranceActive, not recruiting
Centr Georges Francois Leclerc
Coordinator of this site? Confirm its status
DijonFranceActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.