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    Summary
    EudraCT Number:2010-019463-10
    Sponsor's Protocol Code Number:BOXE-1
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-05-10
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2010-019463-10
    A.3Full title of the trial
    MULTICENTER PHASE II STUDY FOR THE EVALUATION OF BEVACIZUMAB, OXALIPLATIN AND CAPECITABINE IN THE TREATMENT OF ELDERLY PATIENTS WITH ADVANCED COLORECTAL CANCER
    STUDIO MULTICENTRICO DI FASE II PER LA VALUTAZIONE DELL'ASSOCIAZIONE DI BEVACIZUMAB (AVASTIN), OXALIPLATINO E CAPECITABINA (XELODA) NEL TRATTAMENTO DEI PAZIENTI ANZIANI (ELDERLY) AFFETTI DA CANCRO DEL COLON-RETTO AVANZATO (BOXE TRIAL)
    A.3.2Name or abbreviated title of the trial where available
    BOXE
    BOXE
    A.4.1Sponsor's protocol code numberBOXE-1
    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 SponsorAZIENDA OSPEDALIERA S. CARLO
    B.1.3.4CountryItaly
    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 XELODA
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCapecitabine
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.3Concentration number2
    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 Yes
    D.3.11.13.1Other medicinal product typechimica
    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 OXALIPLATINO RAT
    D.2.1.1.2Name of the Marketing Authorisation holderRATIOPHARM ITALIA Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Powder and solvent for 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.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.3Concentration number130
    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 Yes
    D.3.11.13.1Other medicinal product typechimica
    D.IMP: 3
    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 AVASTIN
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 INNBevacizumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.3Concentration number7.5
    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) 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) Yes
    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
    advanced colorectal cancer
    cancro del colon-retto avanzato.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level SOC
    E.1.2Classification code 10017947
    E.1.2Term Gastrointestinal disorders
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    activity and toxicity of the proposed combination.
    valutare l’attivita' (risposte obiettive e TTP) e la tossicita' della combinazione proposta nel trattamento di pazienti anziani affetti da cancro del colon-retto avanzato
    E.2.2Secondary objectives of the trial
    treatment effects on quality of life; prognostic evaluation of comorbities; chemotherapy effects on patients'ability during chemotherapy.
    verificare gli effetti del trattamento previsto sulla qualita' di vita (questionario EORTC QLQ-C30-LC13) dei pazienti; valutare il significato prognostico di possibili patologie concomitanti (comorbidita'); valutare gli effetti della chemioterapia sullo stato di abilita' dei pazienti rivalutato nel corso del trattamento.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    LIFE QUALITY:
    Vers:2
    Date:2010/05/26
    Title:
    Objectives:
    QUALITA DELLA VITA:
    Vers:2
    Data:2010/05/26
    Titolo:Valutazione della qualita' della vita in rapporto al trattamento praticato
    Obiettivi:valutare se i parametri oggetto di studio siano alterati dalla tossicita' e dall'efficacia della chemioterapia
    E.3Principal inclusion criteria
    1) diagnosis of colorectal cancer; 2) age >= 70 years; 3) measurable lesions; 4) no previous chemotherapy treatment; 5) life expectancy almost of 12 weeks.
    1) Diagnosi istologica o citologia confermata di carcinoma del colon-retto. 2) Eta' &gt; 70 anni. 3) Presenza di metastasi e/o tumore primitivo, misurabili unidimensionalmente con tecniche strumentali: Rx, Eco, Tc, RMN. 4) Nessun precedente trattamento chemioterapico. E’ ammessa una precedente radioterapia sulle lesioni non utilizzate per la misurazione o un trattamento chemioterapico adiuvante terminato da almeno 6 mesi. 5) Pazienti con carcinoma colorettale resecato che sviluppano metastasi non richiedono una conferma citologica od istologica a meno che non siano trascorsi &gt; 5 anni dalla chirurgia primaria alla ricaduta o da precedente neoplasia di stadio I. 6) Aspettativa di vita di almeno 12 settimane. 7) Escrezione urinaria adeguata (se proteine urinarie &gt; 30 mg/dL o +1 con metodica dipstick, il paziente deve presentare un valore = 1 g di proteine urinarie/24h). 8) INR o APTT &lt; 1.5 x ULN e D-dimero entro il range di normalita' del laboratorio locale (per valori anomali devono essere esclusi eventi tromboembolici). 9) Adeguata compliance del paziente
    E.4Principal exclusion criteria
    1) Performance Status (ECOG)> 2; 2) >3 comorbidities; 3) previous chemotherapy for advanced disease; 4) brain metastasis; 5) other malignancies.
    1) Performance status (ECOG) &gt; 2. 2) &gt;3 comorbidita'. 3) Precedenti trattamenti chemioterapici, fatta eccezione per terapie adiuvanti terminate almeno 6 mesi prima della inclusione nello studio. 4) Presenza di metastasi cerebrali. 5) Presenza di metastasi ossee come unico segno di malattia. 6) Presenza di seconda neoplasia, fatta eccezione per il basalioma cutaneo ed il ca. in situ della cervice uterina. 7) Inaccessibilita' geografica o manifeste turbe psico-caratteriali che possono rendere difficoltoso il trattamento ed il successivo follow-up. 8) Neutrofili &lt; 2.000/mm3 o PLT 100.000/mm3 o Hb &lt; 10 g/dl., Creatinina &gt; 1.5 mg/dl ULN o creatinina clearance &lt;50 mL/min (calcolata secondo la formula standard di Cockcroft e Gault), GOT o GPT o bilirubinemia &gt; 1.25 volte il valore normale massimo, tranne che se causate dal tumore (metastasi epatiche). 9) Patologie concomitanti che controindicano la somministrazione dei farmaci citotossici a giudizio del clinico. 10) Rifiuto del consenso informato. 11) Precedente trattamento con bevacizumab o altro agente anti-angiogenico. 12) Partecipazione ad un altro studio clinico con somministrazione di qualunque farmaco sperimentale nei 30 giorni precedenti l’arruolamento. 13) Neuropatia periferica di grado &gt; 1 (criteri NCI CTCAE, v3.0). 14) Malattie cardiovascolari clinicamente significative (per es. eventi cerebrovascolari = 6 mesi precedenti all’arruolamento), infarto del miocardio (= 1 anno precedente all’arruolamento), ipertensione non controllata farmacologicamente, angina instabile, insufficienza cardiaca congestizia NYHA di grado =2, o aritmia cardiaca grave farmacologicamente trattata. 15) Sindrome da malassorbimento o perdita dell’integrita' del tratto gastrointestinale. Diverticolosi. Pazienti con colostomia o ileostomia possono essere eleggibili a discrezione dello sperimentatore. Precedente fistola tracheo-esofagea o qualunque altro tipo di fistola (es. addominale), perforazione gastrointestinale, ascesso intra-addominale. 16) Polmonite interstiziale o fibrosi sintomatica estesa dei polmoni. 17) Ferite gravi non rimarginate, ulcere o fratture ossee; trauma significativo entro 4 settimane dall’arruolamento (esclusa la guarigione completa). 18) Chirurgia maggiore (es. laparotomia) &lt; 4 settimane prima dell’arruolamento. 19) Chirurgia minore &lt; 2 settimane prima dell’arruolamento. I pazienti potranno essere arruolati nello studio soltanto a risoluzione di tutte le tossicita' dovute alla chirurgia. 20) Diatesi emorragica o coagulopatia. 21) Embolia polmonare e qualunque altro tromboembolismo arterioso. 22) Trombosi venosa profonda o qualunque altro evento tromboembolico significativo. 23) Malattia vascolare periferica clinicamente significativa. 24) Precedente trapianto d’organo per cui e' richiesta una terapia immunosoppressiva. 25) Uso cronico di aspirina (&gt;325 mg/die) o altro agente antiinfiammatorio non steroideo (se accertata inibizione della funzione piastrinica a dosi impiegate nel trattamento cronico delle malattie infiammatorie); in trattamento con agenti antipiastrinici (es. clopidogrel &gt; 75 mg/die, ticlopidina, dipiridamolo); in trattamento con sorivudina o suo analogo (es. brivudina). 26) Anticoagulanti o trombolitici, parenterali od orali a dose piena, assunti a scopo terapeutico = 10 giorni dall’arruolamento. 27) Precedente embolizzazione o termoablazione delle metastasi entro 30 giorni precedenti la randomizzazione nello studio. Se queste lesioni sono l’unico sito di malattia devono essere in progressione dopo queste procedure perche' il paziente possa diventare eleggibile.
    E.5 End points
    E.5.1Primary end point(s)
    activity and toxicity of the proposed combination.
    valutare l’attivita' (risposte obiettive e TTP) e la tossicita' della combinazione proposta nel trattamento di pazienti anziani affetti da cancro del colon-retto avanzato
    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 No
    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) 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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial0
    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 concerned7
    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
    fino alla valutazione dell'attivita' e della tossicita' relative all'ultimo paziente trattato.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months30
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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) No
    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 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 state44
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 44
    F.4.2.2In the whole clinical trial 44
    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 Decision2010-12-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-09-30
    P. End of Trial
    P.End of Trial StatusOngoing
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