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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)

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ClinicalTrials.gov Identifier: NCT03584711
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : July 26, 2019
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive

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

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Combination Product: FOLFOX + panitumumab Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 26, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Panitumumab

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




Primary Outcome Measures :
  1. Time to failure of the strategy [ Time Frame: Up to 20 months ]
    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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584711


Contacts
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Contact: lila gaba 0380393483 lila.gaba@u-bourgogne.fr
Contact: jeremie bez 0380393483 jeremie.bez@u-bourgogne.fr

Locations
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France
Clinique Trenel Recruiting
Sainte Colombe, Lyon, France, 69560
Contact: Ivan GRABER, Dr       graber.trenel@gmail.com   
Clinique Claude Bernard Recruiting
Albi, France, 81030
Contact: Yann Berge, Dr       berge@claude-bernard-albi.com   
Hopital Sud Recruiting
Amiens, France, 80054
Contact: Vincent HAUTEFEUILLE, Dr       hautefeuille.vincent@chu-amiens.fr   
Clinique de L'Europe Recruiting
Amiens, France, 80090
Contact: Michel Gozy, Dr       michelgozy@gmail.com   
Chu D'Angers Recruiting
Angers CEDEX 9, France, 49933
Contact: Carole VITELLIUS, Dr       carole.vitellius@chu-angers.fr; carole.vitellius@wanadoo.fr; cvitellius@gmail.com   
Hopital Prive D'Antony Recruiting
Antony, France, 92166
Contact: Anne THIROT BIDAULT, Dr       a.t.bidault@gmail.com   
Hopital Les Bonnettes Recruiting
Arras CEDEX, France, 62012
Contact: Bruno HUGUENIN, Dr       drbhuguenin@orange.fr   
Centre Marie Curie Recruiting
Arras, France, 62000
Contact: Anne-Sophie BLANC-GUERINEAU       drblanc@radiopole-artois.com   
Ch Cote Basque Recruiting
Bayonne CEDEX, France, 64109
Contact: Franck AUDEMAR, Dr       faudemar@ch-cotebasque.fr   
Ch de Beauvais Recruiting
Beauvais, France, 60021
Contact: Fayçal HOCINE, Dr       f.hocine@ch-beauvais.fr ; fayoncologie@yahoo.fr   
Polyclinique Saint Privat Recruiting
Boujan-sur-Libron, France, 34760
Contact: Michaël HUMMELSBERGER, Dr       michael.hummelsberger@orange.fr   
Cmco Cote D'Opale Recruiting
Boulogne-sur-Mer, France, 62222
Contact: Laurent GASNAULT, Dr       laurent.gasnault@sfr.fr   
Hopital Duchenne Recruiting
Boulogne-sur-Mer, France, 62321
Contact: Vincent BOURGEOIS, Dr       vincebourgeois@hotmail.com   
Hopital Morvan - Chu Recruiting
Brest, France, 29609
Contact: Jean-Philippe METGES, Dr       jean-philippe.metges@chu-brest.fr   
Ch de Beziers Cedex Recruiting
Béziers, France, 34525
Contact: Mohamed RAMDANI, Dr       mohamed.ramdani@ch-beziers.fr   
Centre Francois Baclesse Recruiting
Caen, France, 14076
Contact: Stéphane CORBINAIS, Dr       s.corbinais@baclesse.unicancer.fr   
Ch Cahors Recruiting
Cahors, France, 46000
Contact: Nadia LEVASSEUR, Dr       nadia.levasseur@ch-cahors.fr   
Ch de Cholet Recruiting
Cholet, France, 49325
Contact: Frédérique ALABERT, Dr       frederique.alabert@ch-cholet.fr   
Centre Hospitalier General Recruiting
Châlons-en-Champagne, France, 51005
Contact: ROCH ANICET OSSENDZA, Dr       rochossendza@yahoo.fr   
Hopitaux Civils de Colmar Recruiting
Colmar, France, 68024
Contact: Gilles BREYSACHER, Dr       gilles.breysacher@ch-colmar.fr   
Service de Medecine Recruiting
Digne-les-Bains, France, 04000
Contact: Gilbert BORDES, Dr       gbordes@ch-digne.fr   
CH Recruiting
Dunkerque CEDEX 01, France, 59385
Contact: Tatiana CEBAN RUDIC, Dr       tatiana.ceban@ch-dunkerque.fr   
Hopital Jacques Monod Recruiting
Flers CEDEX, France, 61104
Contact: Pierre-Emmanuel HENNERESSE, Dr       pierre-emmanuel.henneresse@ch-flers.fr ; netpeh@orange.fr; p.e.henneresse@wanadoo.fr   
Chi de Frejus Saint-Raphael Recruiting
Fréjus, France, 83600
Contact: Bruno VALENZA, Dr       valenza-b@chi-frejus-saint-raphael.fr;oncologie-sec@chi-fsr.fr; brunovalenza@msn.com   
Polyclinique de Blois - 3Eme Etage Recruiting
La Chaussee St Victor, France, 41260
Contact: Philippe LAPLAIGE, Dr       dr.laplaige@wanadoo.fr   
Chd Vendee Recruiting
La Roche-sur-Yon, France, 85925
Contact: Roger FAROUX, Dr       roger.faroux@chd-vendee.fr   
Ch Du Mans Recruiting
Le Mans CEDEX 9, France, 72037
Contact: Oana COJOCARASU, Dr       ocojocarasu@ch-lemans.fr; oanaalexa@hotmail.com   
Centre Hospitalier Schaffner Recruiting
Lens, France, 62307
Contact: Alice PHAM-BECKER, Dr       apham@ch-lens.fr   
Chru Hopital Claude Huriez 4Eme Est Recruiting
Lille, France, 59037
Contact: Anthony TURPIN, Dr       turpin.anth@yahoo.fr; anthony.turpin@chru-lille.fr   
Ch St Joseph-St Luc Recruiting
Lyon, France, 69365
Contact: Denis PERE VERGE, Dr       dpereverge@ch-stjoseph-stluc-lyon.fr; fannydenis@sfr.fr   
Hopital Europeen Marseille Recruiting
Marseille, France, 13331
Contact: Yves RINALDI, Dr       y.rinaldi@hopital-europeen.fr; yrinaldi@wanadoo.fr   
Ch de Meaux Recruiting
Meaux, France, 77100
Contact: Christophe LOCHER, Dr       c-locher@ch-meaux.fr   
Hopital Layne Recruiting
Mont-de-Marsan, France, 40024
Contact: Jérôme DAUBA, Dr       jerome.dauba@ch-mt-marsan.fr   
Polyclinique de Gentilly Recruiting
Nancy, France, 54100
Contact: Fabien BROCARD, Dr       f.brocard@oncog.fr   
Hopital Prive Du Confluent Sas Recruiting
Nantes, France, 44277
Contact: Benjamin LINOT, Dr       benjamin.linot@groupeconfluent.fr   
Ch de Niort - Sce D'Oncologie Recruiting
Niort CEDEX, France, 79021
Contact: Albert ALEBA, Dr       albert.aleba@ch-niort.fr   
Groupe Hospitalier Pitie-Salpetriere Recruiting
Paris CEDEX 13, France, 75651
Contact: Jean-Baptiste BACHET, Dr       jean-baptiste.bachet@aphp.fr   
Chu Cochin Recruiting
Paris, France, 75014
Contact: Romain CORIAT, Pr       romain.coriat@aphp.fr   
Groupe Hospitalier Pitie-Salpetriere Recruiting
Paris, France
Contact: Jean-Baptiste Bachet, Pr         
Polyclinique de Courlancy Recruiting
Reims, France, 51100
Contact: Karinne PRULHIER-CORVIOLE, Dr       kpulhiere@iccreims.fr   
Centre Hospitalier Recruiting
Saint-Quentin CEDEX, France, 02321
Contact: Innocenti DADAMESSI, Dr       I.dadamessi@ch-stquentin.fr;dadamessi@gmail.com   
Clinique Ste Anne Recruiting
Strasbourg, France, 67000
Contact: Louis-Marie DOURTHE, Dr       lm.dourthe@solcrr.org   
Centre Paul Strauss Recruiting
Strasbourg, France, 67065
Contact: Meher BEN ABDELGHANI, Dr       mbenabdelghani@strasbourg.unicancer.fr   
Polyclinique de L'Ormeau Recruiting
Tarbes, France, 65000
Contact: Philippe AYELA, Dr       Payela@ch-lourdes.fr ; philippe.ayela@sfr.fr ; nathaliemonteiro@wanadoo.fr   
Clinique Pasteur Recruiting
Toulouse, France, 31076
Contact: Mathilde MARTINEZ, Dr       m.martinez@clinique-pasteur.com   
Martinique
Chu de Fort de France Recruiting
Fort-de-France, Martinique, 97261
Contact: Nathalie GROSSAT BERNADOU, Dr       nathalie.grossat-bernadou@chu-martinique.fr   
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Amgen
Investigators
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Principal Investigator: Jean-Baptiste Bachet, Pr Federation Francophone de Cancerologie Digestive

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Responsible Party: Federation Francophone de Cancerologie Digestive
ClinicalTrials.gov Identifier: NCT03584711     History of Changes
Other Study ID Numbers: FFCD 1605
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Federation Francophone de Cancerologie Digestive:
Stop and Go strategy
RAS Wild-type

Additional relevant MeSH terms:
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Colorectal Neoplasms
Adenocarcinoma
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Panitumumab
Antineoplastic Agents, Immunological
Antineoplastic Agents