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

Primary Purpose

Colorectal Cancer

Status

Active

Phase

Phase 1

Locations

France

Study Type

Interventional

Intervention

FOLFIRINOX Bevacizumab

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring FOLFIRINOX3 Bevacizumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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.

Sites / Locations

Centre Georges François Leclerc

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Administration of chemotherapy molecules

Arm Description

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03795311

First Posted

January 2, 2019

Last Updated

October 16, 2023

Sponsor

Centre Georges Francois Leclerc

1. Study Identification

Unique Protocol Identification Number

NCT03795311

Brief Title

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

Acronym

FOLFIRINOX3

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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 7, 2018 (Actual)

Primary Completion Date

November 21, 2024 (Anticipated)

Study Completion Date

November 21, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Georges Francois Leclerc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

Keywords

FOLFIRINOX3 Bevacizumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Administration of chemotherapy molecules

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

FOLFIRINOX Bevacizumab

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Participants with Acute toxicities as a Measure of treatment specific Safety and Tolerability

Description

Acute toxicities will be assessed according to the NCI CTCAE v4.03

Time Frame

each chemotherapy cycle (15 days) up to progression (6 months on average)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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: 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.

Facility Information:

Facility Name

Centre Georges François Leclerc

City

Dijon

ZIP/Postal Code

21000

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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