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 (OPTIPRIME)

A Phase II Study Evaluating 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

Single-arm, multi-centre phase II study The primary objective is to evaluate the time to failure of the strategy.

Study Overview

• Status: Completed
• Conditions: Metastatic Colorectal Cancer
• Intervention / Treatment: Combination product: FOLFOX + panitumumab

Detailed Description

The purpose of the OPTIPRIME phase II non-randomised study is to evaluate the efficacy and tolerability of the combination of FOLFOX plus panitumumab according to a "stop and go" strategy. If disease control is achieved while on induction treatment, oxaliplatin and panitumumab will be stopped after the sixth cycle; a maintenance treatment of fluoropyrimidine alone will be continued. In case of progression during maintenance treatment, oxaliplatin and panitumumab reintroduction loops will take place according to the same regimen (maintenance treatment after six cycles of the reintroduced therapy if disease control is achieved).

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Albi, France
    • Clinique Claude Bernard
  • Albi, France, 81030
    • Clinique Claude Bernard
  • Amiens, France
    • Clinique de l'Europe
  • Amiens, France, 80090
    • Clinique de l'Europe
  • Amiens, France, 80054
    • Hopital Sud
  • Amiens, France
    • CHU Amiens Picardie Hôpital Sud
  • Angers, France
    • CHU
  • Angers CEDEX 9, France, 49933
    • CHU d'Angers
  • Antony, France, 92166
    • Hopital Prive d'Antony
  • Antony, France
    • Hôpital Privé
  • Arras, France, 62000
    • Centre Marie Curie
  • Arras, France
    • Centre Marie Curie
  • Arras, France
    • Hôpital Privé les Bonnettes
  • Arras CEDEX, France, 62012
    • Hopital Les Bonnettes
  • Avignon, France
    • Institut Sainte Catherine
  • Avignon, France
    • CH Henri Duffaut
  • Bayonne, France
    • Centre Hospitalier Côte Basque
  • Bayonne CEDEX, France, 64109
    • CH Côte Basque
  • Beauvais, France, 60021
    • CH de BEAUVAIS
  • Beauvais, France
    • Centre Hospitalier
  • Boujan-sur-Libron, France, 34760
    • Polyclinique Saint Privat
  • Boulogne-sur-Mer, France
    • Hôpital Duchenne
  • Boulogne-sur-Mer, France, 62222
    • Cmco Cote D'Opale
  • Boulogne-sur-Mer, France, 62321
    • Hôpital Duchenne
  • Brest, France
    • CHU
  • Brest, France, 29609
    • Hopital Morvan - Chu
  • Béziers, France
    • Centre Hospitalier
  • Béziers, France, 34525
    • Ch de Beziers Cedex
  • Caen, France
    • Centre Francois Baclesse
  • Caen, France, 14076
    • Centre Francois Baclesse
  • Cahors, France, 46000
    • CH Cahors
  • Challans, France
    • Loire Vendee Ocean
  • Chartres, France
    • Hôpital Louis Pasteur
  • Cholet, France
    • Centre Hospitalier
  • Cholet, France, 49325
    • CH de Cholet
  • Châlons-en-Champagne, France, 51005
    • Centre Hospitalier Général
  • Châlons-en-Champagne, France
    • Centre Hospitalier
  • Colmar, France, 68024
    • Hôpitaux Civils de Colmar
  • Colmar, France
    • Hôpitaux Civils de Colmar
  • Corbeil-Essonnes, France
    • Centre Hospitalier Sud Francilien
  • Coudekerque-Branche, France
    • Clinique de Flandre
  • Digne-les-Bains, France, 04000
    • Service de Medecine
  • Digne-les-Bains, France
    • Centre Hospitalier
  • Dijon, France
    • CHU
  • Dijon, France
    • Centre G. François Leclerc
  • Dunkerque, France
    • Centre Hospitalier
  • Dunkerque CEDEX 01, France, 59385
    • CH
  • FORT DE France, France
    • CHU Martanique Hôpital Clarac
  • Flers, France
    • CH J Monod
  • Flers CEDEX, France, 61104
    • Hopital Jacques Monod
  • Fréjus, France, 83600
    • Chi de Frejus Saint-Raphael
  • Fréjus, France
    • CHI Fréjus St Raphaël
  • Grenoble, France
    • Hôpital Michallon
  • Kremlin Bicêtre, France
    • Hôpital Bicêtre
  • La Chaussee St Victor, France, 41260
    • Polyclinique de Blois - 3Eme Etage
  • La Chaussée-Saint-Victor, France
    • Polyclinique Blois
  • La Roche-sur-Yon, France, 85925
    • CHD Vendee
  • La Roche-sur-Yon, France
    • CHD VENDEE (Les Oudairies)
  • Le Mans, France
    • Centre Hospitalier
  • Le Mans CEDEX 9, France, 72037
    • CH du Mans
  • Lens, France, 62307
    • Centre Hospitalier Schaffner
  • Lens, France
    • Centre Hospitalier
  • Lille, France
    • CHU Claude Huriez
  • Lille, France
    • Hopital prive Le Bois
  • Lille, France, 59037
    • Chru Hopital Claude Huriez 4Eme Est
  • Lyon, France, 69365
    • Ch St Joseph-St Luc
  • Lyon, France
    • CH Saint Joseph St Luc
  • Lyon, France
    • Prive - Jean Mermoz
  • Mantes-la-Jolie, France
    • Chi F. Quesnay
  • Marseille, France
    • Hopital Europeen
  • Marseille, France, 13331
    • Hopital Europeen Marseille
  • Meaux, France, 77100
    • CH de Meaux
  • Meaux, France
    • Centre Hospitalier
  • Mont-de-Marsan, France, 40024
    • Hôpital Layne
  • Montfermeil, France
    • CHI
  • Montélimar, France
    • Centre Hospitalier
  • Nancy, France, 54100
    • Polyclinique de Gentilly
  • Nancy, France
    • Centre d'oncologie de Gentilly
  • Nantes, France, 44277
    • Hopital Prive du Confluent SAS
  • Nantes, France
    • Le Confluent SAS
  • Niort, France
    • Centre Hospitalier
  • Niort CEDEX, France, 79021
    • Ch de Niort - Sce D'Oncologie
  • Orléans, France
    • CHR
  • Paris, France
    • HEGP
  • Paris, France, 75014
    • CHU Cochin
  • Paris, France
    • Groupe Hospitalier Pitie-Salpetriere
  • Paris, France
    • Hôpital Cochin (APHP)
  • Paris, France
    • La Pitie Salpetriere
  • Paris, France
    • CHU Bichat
  • Paris, France
    • Groupe Diaconnesses Croix St Simon
  • Paris CEDEX 13, France, 75651
    • Groupe Hospitalier Pitie-Salpetriere
  • Pessac, France
    • Hopital Haut Leveque
  • Poitiers, France
    • CHU
  • Périgueux, France
    • Polyclinique Francheville
  • Périgueux, France
    • Centre Hospitalier
  • Quint-Fonsegrives, France
    • Clinique de la Croix du Sud
  • Reims, France, 51100
    • Polyclinique de Courlancy
  • Reims, France
    • Institut du Cancer Courlancy
  • Romans-sur-Isère, France
    • CH de Romans
  • Roubaix, France
    • Centre Hospitalier
  • Rouen, France
    • CHU
  • Rouen, France
    • Saint Hilaire - Privee
  • Saint-Grégoire, France
    • CHP
  • Saint-Jean, France
    • Clinique de l'Union
  • Saint-Martin-Boulogne, France
    • Centre Médical Côte d'Opale
  • Saint-Priest-en-Jarez, France
    • Hopital Nord Chu Saint Etienne
  • Saint-Quentin, France
    • Centre Hospitalier
  • Saint-Quentin CEDEX, France, 02321
    • Centre Hospitalier
  • Sainte-Colombe, France
    • Clinique Trenel
  • Sainte-Foy-lès-Lyon, France
    • Clinique Charcot
  • Strasbourg, France, 67000
    • Clinique Ste Anne
  • Strasbourg, France, 67065
    • Centre Paul Strauss
  • Strasbourg, France
    • Centre Paul Strauss
  • Strasbourg, France
    • Clinique Sainte Anne
  • Tarbes, France, 65000
    • Polyclinique de l'Ormeau
  • Toulon, France
    • Hopital Sainte Musse
  • Toulouse, France, 31076
    • Clinique Pasteur
  • Toulouse, France
    • Clinique Pasteur
  • Tours, France
    • CHRU
  • Valenciennes, France
    • Clinique des dentellières
  • Villeneuve-d'Ascq, France
    • Hôpital Privé
  • Villeurbanne, France
    • Médipôle Hôpital Mutualiste Lyon Villeurbanne
  • Lyon
    • Sainte Colombe, Lyon, France, 69560
      • Clinique Trenel
• Martinique
  • Fort-de-France, Martinique, 97261
    • CHU de Fort de France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• - Histologically proven colorectal adenocarcinoma without RAS mutation
• 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:

• - Presence of uncontrolled symptomatic brain metastases
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Combination product: FOLFOX + panitumumab; FOLFOX + panitumumab according to a "stop and go" strategy with a reintroduction loop after progression on fluoropyrimidine as maintenance treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to failure of the strategy	Time to strategy Failure is defined as the time from date of inclusion to strategy failure (Radiological progression under treatment or death or definitive treatment discontinuation or recurrence after curative surgery with or without adjuvant treatment)	Up to 20 months

Collaborators and Investigators

• Sponsor: Federation Francophone de Cancerologie Digestive
• Collaborators: Amgen
• Investigators: Principal Investigator: Jean-Baptiste Bachet, Pr, Federation Francophone de Cancerologie Digestive

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2018
• Primary Completion (Actual): March 30, 2025
• Study Completion (Actual): March 30, 2025

Study Registration Dates

• First Submitted: June 19, 2018
• First Submitted That Met QC Criteria: June 29, 2018
• First Posted (Actual): July 12, 2018

Study Record Updates

• Last Update Posted (Actual): June 29, 2025
• Last Update Submitted That Met QC Criteria: June 27, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Stop and Go strategy; RAS Wild-type
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Adenocarcinoma; Antineoplastic Agents, Immunological; Antineoplastic Agents; Panitumumab
• Other Study ID Numbers: FFCD 1605

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No