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    Summary
    EudraCT Number:2006-001067-39
    Sponsor's Protocol Code Number:CSET 1207
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2009-03-30
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2006-001067-39
    A.3Full title of the trial
    Etude de phase II de l'association 5-fluoro-uracile - acide folinique (schéma LV5FU2 simplifié) et cetuximab en intraveineux avec une chimiothérapie intra-artérielle hépatique par Oxaliplatine dans le cancer colorectal avec métastases hépatiques non opérables.
    A.3.2Name or abbreviated title of the trial where available
    CHOICE
    A.4.1Sponsor's protocol code numberCSET 1207
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorInstitut Gustave Roussy
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    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 Erbitux 5mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderMerck KGaA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Information not present in EudraCT
    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 INNCetuximab
    D.3.9.2Current sponsor codeEMD271786
    D.3.9.3Other descriptive namecetuximab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10052362
    E.1.2Term Metastatic colorectal cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluer l’efficacité du traitement sur le taux de réponse objective (RECIST)
    E.2.2Secondary objectives of the trial
    Evaluer la toxicité du traitement (NCI-CTCAE version 3.0),
    Evaluer la durée de réponse tumorale (RECIST),
    Evaluer la durée et le taux de contrôle tumoral (réponses objectives et stabilisations) (RECIST),
    Evaluer le taux de résécabilité secondaire des métastases hépatiques,
    Evaluer la survie sans progression tumorale et le taux de progression tumorale (globale, intra-hépatique, extra-hépatique),
    Evaluer la survie globale.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    - Métastases hépatiques de cancer colique ou rectal (preuve histologique obtenue sur la tumeur primitive ou les métastases hépatiques) :
    o Isolées (pas de métastase extra-hépatique),
    o Non accessibles à une hépatectomie à visée curative (résection prévisible non R0 ou laissant moins de 30% de foie résiduel non tumoral normalement vascularisé), ou requérant une hépatectomie complexe, très large (5 segments ou plus) et/ou risquée (classe II des RPC),
    o Dont au moins une mesurable par les critères RECIST (³ 2 cm, ou ³ 1 cm si tomodensitométrie (TDM) spiralée)
    - Absence de mutation tumorale de K-ras (statut tumoral K-ras sauvage)
    -Age compris entre 18 et 75 ans
    -Etat général OMS de 0 ou 1- Espérance de vie > 3 mois
    -Bilirubinémie £ 1,5 fois la limite normale supérieure (N), ASAT et ALAT £ 5 N, créatininémie £ 1,5 N, neutrophiles ³ 1,5 x 109/L, plaquettes ³ 100 x 109/L, hémoglobine ³ 9 g/dL (patients incluables même s’ils ont été transfusés)
    -TDM (ou IRM) de référence pour la mesure des métastases fait dans les 21 28 jours précédant le premier cycle de traitement
    -Consentement éclairé signé
    E.4Principal exclusion criteria
    - Métastases extra-hépatiques (la présence d’au plus 3 nodules pulmonaires de moins de 5 mm de diamètre maximal, d’aspect non spécifique de métastase, y compris après tomographie par émission de positons [TEP] dans les cas jugés douteux, ne constitue pas un critère de non-inclusion)
    -Tumeur colique ou rectale primitive en place symptomatique ([sub]occlusion, hémorragie significative, syndrome rectal important)
    -Contre-indication ou allergie de grade 3-4 à un des composés des traitements
    -Neuropathie périphérique
    -Chimiothérapie antérieure en situation métastatique (chimiothérapie adjuvante autorisée terminée depuis au moins 6 mois si avec oxaliplatine)
    -En cas de tumeur rectale requérant une irradiation, seule une radiothérapie hypofractionnée courte (5 fois 5 Gy) est autorisée
    -Participation en cours ou dans les 30 jours précédant l’entrée dans l’étude à un autre essai thérapeutique avec une molécule expérimentale
    -Traitement anticancéreux systémique concomitant par immunothérapie, chimiothérapie ou hormonothérapie
    -Administration antérieure de facteur de croissance épidermique (Epidermal Growth Factor, EGF), d’anticorps monoclonaux inhibant les signaux de transduction du récepteur à l’EGF (EGF Receptor, EGFR), ou de tout traitement ciblant l’EGFR
    -Coronaropathie symptomatique ou infarctus du myocarde au cours des 6 mois précédant l’entrée dans l’étude
    -Insuffisance cardiaque ≥ au grade II de la New York Heart Association (NYHA) (Classe II–III-IV), insuffisance rénale sévère
    -Maladie grave non équilibrée, infection active non contrôlée ou autre affection grave sous-jacente susceptible d’empêcher le patient de recevoir le traitement
    -Grossesse (ou test de grossesse positif à l’inclusion), allaitement ou absence de contraception efficace pour les hommes ou femmes en âge de procréer
    -Occlusion ou sub-occlusion intestinale ou antécédent de maladie inflammatoire intestinale
    -Autre cancer dans les 5 années précédant l'entrée dans l'essai ou concomitant (sauf cancer in situ du col de l’utérus ou carcinome baso-cellulaire cutané correctement traité)
    -Incapacité légale (personnes privées de liberté ou sous tutelle)
    -Impossibilité de signer le consentement éclairé ou 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)
    Le critère de jugement principal retenu est le pourcentage de réponses objectives (réponses complètes (RC) + réponses partielles (RP)) selon les critères RECIST, défini comme le rapport du nombre de réponses maximales observées durant le traitement évalué par le nombre total de patients inclus. Les analyses seront effectuées en intention de traiter.
    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 Information not present in EudraCT
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-03-30. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 45
    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 Decision2009-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-05
    P. End of Trial
    P.End of Trial StatusOngoing
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