Etude : PANIRINOX /



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : PANIRINOX

Nom :

Traitement : Métastasique ou localement avancé

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 27/08/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Etude de phase II comparant FOLFIRINOX + Panitumumab versus mFOLFOX6 + Panitumumab dans les cancers colorectaux métastatiques ches des patients dont le statut B-RAF et RAS sauvage a été déterminé à partir de l'analyse de l'ADN tumoral

Spécialité : Organes digestifs
Localisation : C18 - Tumeur maligne du côlon

Spécialité : Organes digestifs
Localisation : C20 - Tumeur maligne du rectum
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : National trial, multicenter, randomized, phase II assessing FOLFIRINOX + Panitumumab versus mFOLFOX6 + Panitumumab in metastatic colorectal cancer patients selected by RAS and B-RAF status from circulating DNA analysis.
Evaluation of complete response rate on treatment combining FOLFIRINOX and panitumumab.

2 treatment arms:
- Experimental: A=Experimental group
FOLFIRINOX + Panitumumab oxaliplatin 85mg/m² IV infusion over 2 hours immediately followed by folinic acid 400mg/m² given as a 2-hour IV infusion with the addition, after 30 minutes of irinotecan 150mg/m² given as a 90-minute intravenous infusion through a Y-connector immediately followed by fluorouracil 400mg/m² IV bolus then 5-FU 2400 mg/m² over 46 hours continuous infusion.
- Active Comparator: B=Control group
mFOLFOX6 + Panitumumab mFOLFOX6 every 2 weeks: oxaliplatin 85mg/m² IV infusion over 2 hours immediately followed by folinic acid 400mg/m² IV infusion over 2 hours followed by fluorouracil 400mg/m² IV bolus then 5-FU 2400mg/m² over 46 hours continuous infusion.

Phase : II

Stade : Métastatique

1
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Age between 18 and 75 years
- ECOG PS between 0 and 1
- Histologically confirmed adenocarcinoma of the colon or rectum
- Untreated synchronous or metachronous metastatic disease deemed unresectable with curative intent
- K-Ras (codons 12, 13, 59, 61, 117, 146), N-Ras (codons 12, 13, 59, 61) and B-Raf (codon 600) wild-type tumor status according to plasma analysis of circulating cell free DNA by Intplex technology
- Measurable disease according to RECIST version 1.1
- Adequate hematologic, hepatic and renal functions:
-> Absolute neutrophil count (ANC) ≥2 x 109/L
-> Haemoglobin ≥9 g/dL
-> Platelets (PTL) ≥100 x 109/L
-> AST/ALT ≤5 x ULN
-> Alkaline phosphatase ≤2.5 x ULN
-> Bilirubin ≤1.5 x ULN
-> Creatinine clearance ≥50 mL/min (Cockcroft and Gault formula)
- Life expectancy of at least 3 months
- Adequate contraception if applicable
- Patient affiliated to a social security regimen
- Patient information and signed written consent form

Critères de non-inclusion : - History of other malignancy within the previous 5 years (except for appropriately treated in-situ cervix carcinoma and non-melanoma skin carcinoma)
- Adjuvant treatment with oxaliplatin
- Previous treatment for metastatic disease
- Patients who received any chemo- and/or radiotherapy within 15 days from the date of blood sampling for the RAS and BRAF test
- Brain metastases
- Patients with a history of severe or life-threatening hypersensitivity to the active substances or to any of the excipients delivered in this study
- Patient with history of pulmonary fibrosis or interstitial pneumonitis
- Previous organ transplantation, HIV or other immunodeficiency syndromes
- Concomitant medications/comorbidities that may prevent the patient from receiving study treatment as uncontrolled intercurrent illness (for instance: active infection, active inflammatory disorders, inflammatory bowel disease, intestinal obstruction, symptomatic congestive heart failure, uncontrolled hypertension…)
- Persistent peripheral neuropathy >grade1 (NCI CT v4.03)
- Ionic disorders as:
-> Kalemia ≤1 x ULN
-> Magnesemia <0.5mmol/L
-> Calcemia <2mmol/L
- Patient with known dihydropyrimidine dehydrogenase deficiency
- QT/QTc>450msec for men and >470msec for women
- Patient with contraindication for trial drugs (investigators have to refer to SmPC drugs, see Appendix 7)
- Concomitant intake of St. John's wort
- Other concomitant cancer
- Patient participating another clinical trial
- Pregnant woman or lactating woman
- Patients with psychological, familial, sociological or geographical condition hampering compliance with the study protocol and follow-up schedule
- Legal incapacity or limited legal capacity
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT02980510
Promoteur :
UNICANCER
Type de sponsor : Institutionnel
75654 Paris Cedex 13 - 75654 Paris Cedex 13
75001 PARIS 01

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre François BACLESSE - 3 avenue du Général Harris - 14000 CAEN

Investigateur :
Marie-Pierre GALAIS

TEC / ARC / IDE :
Boly ANN
Boly.ANN@
mail.baclesse.fr

Ouverture de l'essai : OUVERT

MAJ : 27/08/2019