FOLFOX + Panitumumab According to a "Stop and go" Strategy With a Reintroduction Loop After Progression on Fluoropyrimidine as Maintenance Treatment, as the First Line in Patients With Metastatic Colorectal Adenocarcinoma Without a RAS Mutation
NCT ID: NCT03584711
Last Updated: 2025-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
118 participants
INTERVENTIONAL
2018-04-26
2025-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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FOLFOX + panitumumab
1 cylce every 14 days : Panitumumab : 6 mg/kg en IV (J1) during 60 minutes for 1st infusion followed by 30 to 60 minutes Oxaliplatine : 85 mg/m² inG5% orNaCl 0.9% in IV (D1) during 2 hours Acide folinique : 400 mg/m² (or200 mg/m² if Elvorine) in IV (D1) 5Fu bolus : 400 mg/m² in IV 5FU continu : 2400 mg/m² in IV during 46 hours
LV5FU2 : 1 cycle every 14 days Acide folinique : 400 mg/m² (or 200 mg/m² ifElvorine) in IV (D1) during 2 hours 5FU bolus : 400 mg/m² in IV 5FU continu : 2400 mg/m² in IV during 46 hours
FOLFOX + panitumumab
FOLFOX + panitumumab according to a "stop and go" strategy with a reintroduction loop after progression on fluoropyrimidine as maintenance treatment
Interventions
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FOLFOX + panitumumab
FOLFOX + panitumumab according to a "stop and go" strategy with a reintroduction loop after progression on fluoropyrimidine as maintenance treatment
Eligibility Criteria
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Inclusion Criteria
* Confirmed, non-resectable metastatic disease (Stage IV)
* No prior chemotherapy except perioperative or adjuvant chemotherapy discontinued for more than 12 months
* At least one measurable metastasis according to the RECIST v1.1 criteria
* Age ≥ 18 years
* WHO ≤ 2
* Neutrophils \> 1500 /mm3, platelets\> 100 000/mm3, Hb \> 9 g/dL
* Creatinine clearance \> 50 mL/min according to the MDRD formula
* Serum bilirubin \< 25 µmol/L, AST, ALT, Alk Phos \< 2.5 x ULN or \< 5 x ULN in case of liver metastases
* PT \> 60%, albumin ≥ 25g/L
* Estimated life expectancy ≥ 3 months
* Patient affiliated to a social security scheme
* Patient informed and informed consent form signed
Exclusion Criteria
* RAS mutation (KRAS or NRAS mutation)
* Patient taking warfarin. If treated with anticoagulant at the indicated effective dose, this must be replaced with low molecular weight heparin before inclusion
* Known DPD deficiency
* Peripheral neuropathy \> 1 (NCI CTCAE v4.0)
* Patient with interstitial pneumonitis or pulmonary fibrosis
* History of chronic diarrhoea or inflammatory disease of the colon or rectum, or obstruction or sub-obstruction during symptomatic treatment
* Poorly controlled chronic skin disease
* Any known specific contraindication or allergy to the medicinal products used in the study
* Patient simultaneously included in another clinical trial involving an investigational drug (example: chemotherapy, targeted therapy, immunotherapy)
* Arterial hypertension not controlled by medical treatment (Systolic BP ≥ 160 mmHg end/or diastolic BP ≥ 90 mmHg)
* Any progressive pathology not stabilised over the past 6 months: hepatic failure, renal failure, respiratory failure
* The following conditions in the 6 months prior to inclusion: myocardial infarction, severe/unstable angina, coronary artery bypass surgery, congestive heart failure NYHA class II, III or IV, stroke or transient ischaemic attack
* Patient who has received a transplant, is seropositive for HIV, hepatitis B or hepatitis C or has other immunodeficiency syndromes
* History of malignant pathologies during the past 5 years except basal cell carcinoma of the skin or cervical carcinoma in situ, properly treated
* QT/QTc interval \> 450 msec for men and \> 470 msec for women
* K+ \< LNL, Mg2+ \< LNL, Ca2+ \< LNL
* Lack of effective contraception in patients (men and/or women) of childbearing age, pregnant or breastfeeding women, women of childbearing age who have not had a pregnancy test
* Persons in custody or under wardship
* Impossibility of undergoing medical monitoring during the trial for geographical, social or psychological reasons
18 Years
ALL
Yes
Sponsors
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Amgen
INDUSTRY
Federation Francophone de Cancerologie Digestive
OTHER
Responsible Party
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Principal Investigators
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Jean-Baptiste Bachet, Pr
Role: PRINCIPAL_INVESTIGATOR
Federation Francophone de Cancerologie Digestive
Locations
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Clinique Trenel
Sainte-Colombe, Lyon, France
Clinique Claude Bernard
Albi, , France
Clinique Claude Bernard
Albi, , France
Hopital Sud
Amiens, , France
Clinique de L'Europe
Amiens, , France
CHU Amiens Picardie Hôpital Sud
Amiens, , France
Clinique de l'Europe
Amiens, , France
Chu D'Angers
Angers, , France
CHU
Angers, , France
Hopital Prive D'Antony
Antony, , France
Hôpital Privé
Antony, , France
Centre Marie Curie
Arras, , France
Hopital Les Bonnettes
Arras, , France
Centre Marie Curie
Arras, , France
Hôpital Privé Les Bonnettes
Arras, , France
CH Henri Duffaut
Avignon, , France
Institut Sainte Catherine
Avignon, , France
Ch Cote Basque
Bayonne, , France
Centre Hospitalier Côte Basque
Bayonne, , France
Ch de Beauvais
Beauvais, , France
Centre Hospitalier
Beauvais, , France
Ch de Beziers Cedex
Béziers, , France
Centre Hospitalier
Béziers, , France
Polyclinique Saint Privat
Boujan-sur-Libron, , France
Cmco Cote D'Opale
Boulogne-sur-Mer, , France
Hopital Duchenne
Boulogne-sur-Mer, , France
Hôpital Duchenne
Boulogne-sur-Mer, , France
Hopital Morvan - Chu
Brest, , France
CHU
Brest, , France
Centre Francois Baclesse
Caen, , France
Centre François Baclesse
Caen, , France
Ch Cahors
Cahors, , France
Loire Vendee Ocean
Challans, , France
Hôpital Louis Pasteur
Chartres, , France
Centre Hospitalier General
Châlons-en-Champagne, , France
Centre Hospitalier
Châlons-en-Champagne, , France
Ch de Cholet
Cholet, , France
Centre Hospitalier
Cholet, , France
Hopitaux Civils de Colmar
Colmar, , France
Hôpitaux Civils de Colmar
Colmar, , France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, , France
Clinique de Flandre
Coudekerque-Branche, , France
Service de Medecine
Digne-les-Bains, , France
Centre Hospitalier
Digne-les-Bains, , France
Centre G. François Leclerc
Dijon, , France
CHU
Dijon, , France
CH
Dunkirk, , France
Centre Hospitalier
Dunkirk, , France
Hopital Jacques Monod
Flers, , France
CH J Monod
Flers, , France
CHU Martanique Hôpital Clarac
FORT de France, , France
Chi de Frejus Saint-Raphael
Fréjus, , France
CHI Fréjus St Raphaël
Fréjus, , France
Hôpital Michallon
Grenoble, , France
Polyclinique de Blois - 3Eme Etage
La Chaussée-Saint-Victor, , France
Polyclinique Blois
La Chaussée-Saint-Victor, , France
Chd Vendee
La Roche-sur-Yon, , France
CHD VENDEE (Les Oudairies)
La Roche-sur-Yon, , France
Hôpital Bicêtre
Le Kremlin-Bicêtre, , France
Ch Du Mans
Le Mans, , France
Centre Hospitalier
Le Mans, , France
Centre Hospitalier Schaffner
Lens, , France
Centre Hospitalier
Lens, , France
Chru Hopital Claude Huriez 4Eme Est
Lille, , France
CHU Claude Huriez
Lille, , France
Hôpital Privé LE BOIS
Lille, , France
Ch St Joseph-St Luc
Lyon, , France
CH Saint Joseph St Luc
Lyon, , France
Prive - Jean Mermoz
Lyon, , France
Chi F. Quesnay
Mantes-la-Jolie, , France
Hopital Europeen Marseille
Marseille, , France
Hôpital Européen
Marseille, , France
Ch de Meaux
Meaux, , France
Centre Hospitalier
Meaux, , France
Hopital Layne
Mont-de-Marsan, , France
Centre Hospitalier
Montélimar, , France
CHI
Montfermeil, , France
Polyclinique de Gentilly
Nancy, , France
Centre d'oncologie de Gentilly
Nancy, , France
Hopital Prive Du Confluent Sas
Nantes, , France
Le Confluent SAS
Nantes, , France
Ch de Niort - Sce D'Oncologie
Niort, , France
Centre Hospitalier
Niort, , France
CHR
Orléans, , France
Chu Cochin
Paris, , France
Groupe Hospitalier Pitie-Salpetriere
Paris, , France
CHU Bichat
Paris, , France
Groupe Diaconnesses Croix St Simon
Paris, , France
Groupe Hospitalier Pitie-Salpetriere
Paris, , France
HEGP
Paris, , France
Hôpital Cochin (APHP)
Paris, , France
La Pitie Salpetriere
Paris, , France
Hôpital Haut Lévêque
Pessac, , France
Centre Hospitalier
Périgueux, , France
Polyclinique Francheville
Périgueux, , France
CHU
Poitiers, , France
Clinique de la Croix du Sud
Quint-Fonsegrives, , France
Polyclinique de Courlancy
Reims, , France
Institut du Cancer Courlancy
Reims, , France
CH de Romans
Romans-sur-Isère, , France
Centre Hospitalier
Roubaix, , France
CHU
Rouen, , France
Saint Hilaire - Privee
Rouen, , France
CHP
Saint-Grégoire, , France
Clinique de l'Union
Saint-Jean, , France
Centre Médical Côte d'Opale
Saint-Martin-Boulogne, , France
Hopital Nord Chu Saint Etienne
Saint-Priest-en-Jarez, , France
Centre Hospitalier
Saint-Quentin, , France
Centre Hospitalier
Saint-Quentin, , France
Clinique Trenel
Sainte-Colombe, , France
Clinique Charcot
Sainte-Foy-lès-Lyon, , France
Clinique Ste Anne
Strasbourg, , France
Centre Paul Strauss
Strasbourg, , France
Centre Paul Strauss
Strasbourg, , France
Clinique Sainte Anne
Strasbourg, , France
Polyclinique de L'Ormeau
Tarbes, , France
Hôpital Sainte Musse
Toulon, , France
Clinique Pasteur
Toulouse, , France
Clinique Pasteur
Toulouse, , France
CHRU
Tours, , France
Clinique des Dentellières
Valenciennes, , France
Hôpital Privé
Villeneuve-d'Ascq, , France
Médipôle Hôpital Mutualiste Lyon Villeurbanne
Villeurbanne, , France
Chu de Fort de France
Fort-de-France, , Martinique
Countries
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Other Identifiers
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FFCD 1605
Identifier Type: -
Identifier Source: org_study_id
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