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    Summary
    EudraCT Number:2016-002393-12
    Sponsor's Protocol Code Number:PRODIGE49
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2017-03-27
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2016-002393-12
    A.3Full title of the trial
    Systemic oxaliplatin or in intra-arterial chemotherapy combined with LV5FU2 and targeted therapy in first-line treatment of metastatic colorectal cancer restricted to the liver
    Oxaliplatine systémique ou en chimiothérapie intra-artérielle combiné au LV5FU2 et une thérapie ciblée en première ligne de traitement des cancers colorectaux métastatiques limités au foie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Systemic oxaliplatin or in intra-arterial chemotherapy combined with LV5FU2 and targeted therapy in first-line treatment of metastatic colorectal cancer restricted to the liver
    Chimiothérapie par oxaliplatine en intra-veineux ou dans le foie combiné à une chimiothérapie par LV5FU2 et une thérapie ciblée en intraveineux chez des patients ayant un cancer colorectal métastatique limité au foie.
    A.3.2Name or abbreviated title of the trial where available
    OSCAR
    A.4.1Sponsor's protocol code numberPRODIGE49
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFédération Francophone de Cancérologie Digestive
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAMGEN
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFédération Francophone de Cancérologie Digestive
    B.5.2Functional name of contact pointChef de projets
    B.5.3 Address:
    B.5.3.1Street AddressFaculté de médecine, 7 bd Jeanne d'Arc, BP 87900
    B.5.3.2Town/ cityDIJON
    B.5.3.3Post code21079 CEDEX
    B.5.3.4CountryFrance
    B.5.4Telephone number+33380393404
    B.5.5Fax number+33380381841
    B.5.6E-mailmarie.moreau@u-bourgogne.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name ELOXATINE
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS FRANCE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOXALIPLATIN
    D.3.9.1CAS number 61825-94-3
    D.3.9.4EV Substance CodeSUB09490MIG
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name ELOXATINE
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS FRANCE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarterial use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOXALIPLATIN
    D.3.9.1CAS number 61825-94-3
    D.3.9.4EV Substance CodeSUB09490MIG
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cancer colorectal métastatique au niveau hépatique
    E.1.1.1Medical condition in easily understood language
    colon cancer and rectal cancer with liver metastasis
    cancer du côlon ou du rectum avec métastases au niveau du foie
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10052358
    E.1.2Term Colorectal cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10052362
    E.1.2Term Metastatic colorectal cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparison of hepatic progression free survival in each arm. Hepatic progression was assessed according to the criteria RECIST v1.1 and according to the investigator.
    Comparaison de la survie sans progression hépatique dans chaque bras. La progression hépatique est évaluée selon les critères RECIST v1.1 et selon l'investigateur
    E.2.2Secondary objectives of the trial
    - Toxicities according to NCI-CTC v4.0
    - Evaluation of the best response under treatment, and progression-free survival (radiation only) after central review of the X-rays
    - Best answer obtained under treatment according to the investigator
    - Overall survival (median)
    - Progression free survival (clinical and/or radiological) (median)
    - Evaluation of quality of life (QLQ-C30)
    - Early tumor response rate (response > 20%) at 8 weeks
    - Response depth
    - Secondary resection rate
    - Histological response in case of secondary resection
    - Evolution of the tumor marker (CEA)
    - Toxicités selon le NCI CTC v4.0
    - Evaluation de la meilleure réponse sous traitement, et survie sans progression (radiologique uniquement) après relecture centralisée des imageries
    - Meilleure réponse obtenue sous traitement selon l'investigateur
    - Survie globale (Médiane)
    - Survie sans progression (clinique et/ou radiologique) (médiane)
    - Evaluation de la qualité de vie (QLQ C30)
    - Taux de réponse tumorale précoce (réponse > 20%) à 8 semaines
    - Profondeur de réponse
    - Taux de résection secondaire
    - Réponse histologique en cas de chirurgie secondaire
    - Evolution du marqueur tumoral (ACE)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A biological research with study of circulating tumoral DNA will be performed.
    Histological study of the tumoral parenchyma and the healthy parenchyma resected after treatment by HIAC will be performed with the sending of blocks at study end.
    Researching different prognostic and radiological factors.
    Une étude biologique avec étude de l'ADN tumoral circulant sera réalisé (avant C1 (J0), avant la perfusion de C3 et à progression ou arrêt du traitement).
    Etude anatomopathologique du parenchyme tumoral et du parenchyme sain réséqué après traitement par CIAH sera réalisée avec envoi des blocs en fin d’étude.
    Recherche des différents facteurs prédictifs et pronostiques radiologiques.
    E.3Principal inclusion criteria
    - Histologically proven colorectal adenocarcinoma with hepatic metastasis(es)
    - At least one measurable hepatic metastasis according to the criteria RECIST v1.1
    - No other metastatic sites except lung nodules accepted if number ≤ 3 and < 10 mm
    - RAS mutation status known (determination of KRAS mutation [exons 2,3 and 4]and NRAS [exons 2,3 and 4])
    - Age ≥ 18
    - OMS ≤ 2
    - No prior chemotherapy except perioperative or adjuvant chemotherapy discontinued for more than 12 months
    - Life expectancy > 3 months
    - PNN > 1500/mm3, platelets > 100 000/mm3, Hb > 9 g/dLq
    - Total bilirubin < 25 µmol/L, AST < 5x UNL, ALT < 5 x UNL, x UNL, ALP < 5 x UNL, PT > 60%, proteinuria from 24H < 1 g
    - Creatinine clearance > 50 mL/min according to MDRD formula
    - Patient affiliated to a social security scheme
    - Patient information and signature of the informed consent
    - Adénocarcinome colorectal histologiquement prouvé avec métastase(s) hépatique (s)
    - Au moins une métastase hépatique mesurable selon les critères RECIST v1.1
    - Pas d’autres sites métastatiques excepté des nodules pulmonaires accepté si nombre ≤ 3 et < 10 mm
    - Statut mutationnel RAS connu (détermination de la mutation KRAS (exons 2,3 et 4) et NRAS (exons 2,3 et 4))
    - Age > 18 ans
    - OMS ≤ 2
    - Pas de chimiothérapie antérieure excepté la chimiothérapie péri-opératoire ou adjuvante arrêtée depuis plus de 12 mois et la 1ère cure de FOLFOX iv sans thérapie ciblée effectuée avant randomisation dans le cadre du protocole
    - Espérance de vie > 3 mois
    - PNN > 1500 /mm3, plaquettes > 100 000/mm3, Hb > 9 g/dL
    - Bilirubinémie totale < 25 µmol/L, ASAT < 5x LSN, ALAT < 5 x LSN, PAL < 5 x LSN, TP > 60%, protéinurie des 24h < 1 g
    - Clairance de la créatinine > 50 mL/min selon formule de MDRD
    - Patient affilié à un régime de sécurité sociale
    - Information du patient et signature du consentement éclairé
    E.4Principal exclusion criteria
    - Contraindications specific to the installation of a KTHIA: thrombosis of the hepatic artery, arterial vascular anatomy may compromise a secondary hepatic resection.
    - Patient immediately eligible for a curative therapy (surgical and/or percutaneous) after discussion in CPR
    - Following alterations in the 6 months prior to inclusion: myocardial infarction, angina, severe/unstable angina, coronary artery bypass surgery, congestive heart failure NYHA class II, III or IV, stroke or transient ischemic attack
    - Hypertension not controlled by medical treatment (SBP> 140 mmHg and/or DBP> 90 mmHg with blood pressure taken according to the diagram of the HAS)
    - A history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess or active gastrointestinal bleeding in the 6 months preceding the start of treatment
    - Progressive gastroduodenal ulcer, wound or fractured bone
    - Abdominal or major extra-abdominal surgery (except diagnostic biopsy) or irradiation in the 4 weeks before starting the treatment
    - Transplant patients, HIV positive or other immune deficiency syndromes
    - Any progressive pathology not balanced over the past 6 months: hepatic failure, renal failure, respiratory failure
    - Peripheral neuropathy > 1 (NCI CT v4.0)
    - Patient with interstitial pneumonitis or pulmonary fibrosis
    - History of chronic diarrhea or inflammatory disease of the colon or rectum, or unresolved occlusion or sub-occlusion in symptomatic treatment
    - History of malignant pathologies during the past 5 years except basocellular skin carcinoma or in situ cervical carcinoma, properly treated
    - Patient already included in another clinical trial with an experimental molecule
    - Any known specific contraindication or allergy to the treatments used in the study (cf RCP Appendix 7)
    - Known deficit in DPD
    - QT/QTc range > 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 not having had a pregnancy test
    - Persons deprived of liberty or under supervision
    - Impossibility of undergoing medical monitoring during the trial for geographic, social or psychological reasons
    - Contre-indication spécifiques à la pose d’un KTIAH: thrombose de l’artère hépatique, anatomie vasculaire artérielle pouvant compromettre une résection hépatique secondaire.
    - Patient éligible d’emblée pour un traitement curatif (chirurgical ou/et percutané) après discussion en RCP
    - Atteintes suivantes au cours des 6 mois précédant l’inclusion : infarctus du myocarde, angine de poitrine sévère/instable, pontage aorto-coronarien, insuffisance cardiaque congestive de classe NYHA II, III ou IV, accident vasculaire cérébral ou accident ischémique transitoire,
    - HTA non contrôlée par un traitement médical (PAS > 140 mmHg et/ou PAD > 90 mmHg avec prise de la tension artérielle selon le schéma de l'HAS)
    - Antécédents de fistule abdominale, perforation gastro-intestinale, abcès intra-abdominal ou saignement gastro-intestinal actif dans les 6 mois précédant le début du traitement
    - Ulcère gastroduodénal évolutif, plaie ou fracture osseuse
    - Acte chirurgical abdominal ou extra-abdominal majeur (exceptée la biopsie diagnostique) ou irradiation dans les 4 semaines précédant le début du traitement
    - Patients transplantés, séropositifs pour le VIH, ou autres syndromes d'immunodéficience
    - Toute affection évolutive non équilibrée au cours des 6 derniers mois : insuffisance hépatique, insuffisance rénale, insuffisance respiratoire
    - Neuropathie périphérique > 1
    - Patient présentant une pneumopathie interstitielle ou une fibrose pulmonaire
    - Antécédent de diarrhée chronique ou de maladie inflammatoire du côlon ou du rectum, ou d’occlusion ou de sub-occlusion non résolues sous traitement symptomatique
    - Antécédent de pathologies malignes dans les 5 dernières années à l’exception du carcinome basocellulaire de la peau considéré en rémission complète ou du carcinome in situ du col utérin correctement traité
    - Patient déjà inclus dans un autre essai thérapeutique avec une molécule expérimentale
    - Toute contre-indication spécifique ou allergie ou hypersensibilité connue aux médicaments utilisés dans l’étude (cf RCP annexe 7)
    - Patient présentant une hypersensibilité aux produits des cellules ovariennes de hamster Chinois (CHO) ou à d’autres anticorps recombinants humains ou humanisés.
    - Déficit connu en DPD
    - Intervalle QT/QTc > 450 msec pour les hommes et > 470 msec pour les femmes
    - K+ < LIN, Mg2+ < LIN, Ca2+ < LIN
    - Absence de contraception efficace chez les patients (homme ou/et femme) en âge de procréer, femme enceinte ou allaitante, femme en âge de procréer n’ayant pas réalisé de test de grossesse
    - Personnes privées de liberté ou sous tutelle
    - Impossibilité de se soumettre au suivi médical de l'essai pour des raisons géographiques, sociales ou psychiques
    E.5 End points
    E.5.1Primary end point(s)
    Hepatic progression free survival (median)
    Survie sans progression hépatique (médiane)
    E.5.1.1Timepoint(s) of evaluation of this end point
    To evaluate the primary end point we need to have 228 events (hepatic progression or death)
    Analyse du critère principal effectué lorsque 228 évènements (progression hépatique ou décès) seront observés
    E.5.2Secondary end point(s)
    - Progression free survival (clinical and/or radiological) (median)
    - Evaluation of quality of life (QLQ-C30)
    - Toxicities according to NCI-CTC v4.0
    - Early tumor response rate (response > 20%) at 8 weeks
    - Response depth
    - Evaluation of the best response under treatment, and progression-free survival (radiation only) after central review of the X-rays
    - Best answer obtained under treatment according to the investigator
    - Histological response in case of secondary resection
    - Evolution of the tumor marker (CEA)
    - Survie sans progression (clinique et/ou radiologique) (médiane)
    - Evaluation de la qualité de vie (QLQ C30)
    - Taux de réponse tumorale précoce (réponse > 20%) à 8 semaines
    - Profondeur de réponse
    - Taux de résection secondaire
    - Réponse histologique en cas de chirurgie secondaire
    - Evolution du marqueur tumoral (ACE)
    E.5.2.1Timepoint(s) of evaluation of this end point
    To evaluate the secondary end points we need to have 228 events (hepatic progression or death)
    Les critères secondaires seront évalués lorsque les 228 évènements (progression hépatique ou décès) seront observés
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    voie d'adminitration de l'oxaliplatine
    intra-arterially oxaliplatin administration
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned45
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of study is the last visit of last patient included in this trial
    La fin de l'étude est la dernière visite du dernier patient inclus dans l'étude
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 168
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state268
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After progression of the desease, patients will be follow up according to thésaurus national de cancérologie digestive (TNCD)
    Après progression de leur maladie sous le traitement de l'étude, les patients seront suivis selon les habitudes du centre et selon les recommandations du thésaurus national de cancérologie digestive (TNCD)
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-08-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-21
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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