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    Summary
    EudraCT Number:2005-005734-12
    Sponsor's Protocol Code Number:GEICAM 2005-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-02-01
    Trial results View 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 ConcernedSpain - AEMPS
    A.2EudraCT number2005-005734-12
    A.3Full title of the trial
    ENSAYO CLÍNICO FASE IV.II, MULTICÉNTRICO, PARA LA ADMINISTRACIÓN DE CAPECITABINA SIMULTÁNEA A RADIOTERAPIA EN PACIENTES CON RECICIVA LOCAL DE CÁNCER DE MAMA Y TUMORES HER2 NEGATIVOS
    A.4.1Sponsor's protocol code numberGEICAM 2005-01
    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 SponsorGEICAM (GRUPO ESPAÑOL DE INVESTIGACIÓN EN CÁNCER DE MAMA)
    B.1.3.4CountrySpain
    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 Products LTD.
    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.3.1Product nameXELODA
    D.3.2Product code capecitabina
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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) 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 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
    Pacientes con recidiva local (resecable o irresecable) de cáncer de mama tras mastectomía, y tumores HER2 negativos, tratadas con capecitabina concomitante a radioterapia como primer tratamiento.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10006198
    E.1.2Term Breast cancer recurrent
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la tasa de respuestas clínicas completas en pacientes con recidiva local (resecable o irresecable) de cáncer de mama tras mastectomía, y tumores HER2 negativos, tratadas con capecitabina concomitante a radioterapia como primer tratamiento.
    E.2.2Secondary objectives of the trial
    •Evaluar el perfil de toxicidad de la administración concomitante de capecitabina y radioterapia .
    •Evaluar la duración de la respuesta.
    •Determinar la potencial correlación entre la eficacia y toxicidad de capecitabina y las variantes de genes implicados en el metabolismo y activación de capecitabina a 5- FU:
    - Polimorfismos de la enzima timidilato sintasa (TS).
    - Polimorfismos de la enzima Metiletentetrahidrofolato reductasa (MTHFR).
    - Polimorfismos de la enzima dihidropirimidina dehidrogenasa (DPD).
    - Polimorfismos en la enzima carboxilesterasa 2.
    - Polimorfismos en la enzima citidina deaminasa (CDD).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Se debe obtener y documentar el consentimiento informado por escrito antes de iniciar los procedimientos específicos del protocolo, incluida la cooperación esperada de las pacientes en el tratamiento y el seguimiento, de acuerdo con las normas ICH de Buena Práctica Clínica.
    2. Cáncer de mama histológicamente demostrado (examen histológico del tumor primario: adenocarcinoma invasivo).
    3. Diagnóstico inicial de cáncer de mama operable tratado con mastectomía.
    4. Diagnóstico actual de recidiva local del cáncer de mama. La recidiva local se define como recurrencia del cáncer de mama en lecho de mastectomía, axila homolateral, ganglios supraclaviculares homolaterales, o piel y tejido subcutáneo. Se admite la recidiva local con lesiones en dos o más de las localizaciones descritas.
    5. Mujeres en régimen ambulatorio de edad 18 años.
    6. Índice del estado funcional de Karnofsky  70 (ECOG 0,1,2).
    7. Pacientes con tumores HER2 negativo.
    8. Adecuada reserva medular (en los 14 días anteriores al comienzo del tratamiento):
    • Hemoglobina  10 g/dl;
    • Leucocitos  3.000/mm3;
    • Neutrófilos  1.500/mm3;
    • Plaquetas 100.000/mm3.
    9. Condiciones funcionales orgánicas normales a nivel renal y hepático (en los 14 días anteriores al comienzo del tratamiento):
    • recuento absoluto de neutrófilos > 1,5 x 109/l;
    • ASAT (SGOT) y ALAT (SGPT) < 1,5 LSN, fosfatasa alcalina< 1,5 LSN,
    • bilirrubina total < 1,5 LSN.
    • Creatinina  175 mol/l (2 mg/dl) o velocidad de aclaramiento de creatinina > 60 ml/min.
    E.4Principal exclusion criteria
    1. Afectación metastásica en órganos o localizaciones a distancia.
    2. Afectación de ganglios de la cadena mamaria interna, clínicamente evidente.
    3. Haber recibido tratamiento radioterápico previo en la mama o en otras localizaciones que comprendan el 30% de la médula ósea.
    4. Haber recibido quimioterapia a altas dosis con trasplante de médula ósea o stem cell periféricas.
    5. Hipersensibilidad conocida a capecitabina, doxifluridina, fluorouracilo o a cualquiera de los excipientes.
    6. Tratamiento previo con capecitabina o con infusión continua (> 24 h) con 5-FU, o con otras fluoropirimidinas orales, tales como eniluracil/5-FU, uracilo/tegafur, S1 o emitefur.
    7. Transplantes alográficos de órganos que requieran terapia inmunosupresora.
    8. Historia de trastornos neurológicos o psiquiátricos significativos, incluidos trastornos sicóticos, demencia o ataques que impedirían a la paciente entender y otorgar el consentimiento informado, interferirían en el cumplimiento de la pauta del fármaco en estudio.
    9. Enfermedad cardiaca clínicamente relevante, tal como insuficiencia cardiaca congestiva o enfermedad arterial coronaria sintomática, arritmias cardiacas no controladas con tratamiento o historia anterior de infarto de miocardio durante los 12 meses anteriores a la inclusión en el estudio, o hipertensión no controlada.
    10. Pacientes con indicios de metástasis en el SNC. Pacientes con historia de convulsiones no controladas, trastornos del sistema nervioso central o discapacidad psiquiátrica que el investigador considere clínicamente significativa para impedir al paciente otorgar el consentimiento informado o que interfiera con el cumplimiento del tratamiento con la medicación oral.
    11. Infección activa no controlada, u otras enfermedades o patologías médicas graves, tales como ulcera péptica activa, diabetes mellitus inestable.
    12. Pacientes sometidos a cirugía mayor durante las 4 semanas anteriores al inicio del tratamiento del estudio o que no se hayan recuperado completamente.
    13. Pacientes con falta de integridad física del tracto gastrointestinal superior o que manifiesten síndrome de mala absorción, o imposibilidad de tomar medicación por vía oral.
    14. Pacientes embarazadas o en período de lactancia. Pacientes con potencial de fertilidad y un resultado desconocido o positivo en la prueba de embarazo en orina o suero, realizada durante los 14 días anteriores a la asignación de tratamiento.
    15. Mujeres en edad fértil que no desean usar un método anticonceptivo fiable y apropiado. Las mujeres postmenopáusicas deben haber permanecido amenorreicas durante al menos 6 meses para ser consideradas como no fértiles.
    16. Transfusiones de sangre o administración de factores de crecimiento para ayudar a la recuperación hematológica en las 2 semanas previas al comienzo del tratamiento del estudio.
    17. Posibilidad de reacción severa no prevista a terapia con fluoropirimidina, con o sin probada deficiencia de dihidropirimidina dehidrogenasa (DPD).
    18. Pacientes con tratamiento anticoagulante con derivados de cumarina.
    19. Pacientes en tratamiento con sorivurina o sus análogos químicamente relacionados, como la brivudina.
    20. Tratamiento concomitante con otros fármacos en investigación. Participación en otro ensayo clínico con cualquier fármaco en investigación no comercializado durante los 30 días previos a la inclusión en el estudio.
    21. Tratamiento concomitante con cualquier otra terapia anticancerosa.
    E.5 End points
    E.5.1Primary end point(s)
    Tasa de respuestas clínicas completas, medidas mediante RM, y criterios RECIST
    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 Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 concerned5
    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 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 months2
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Information not present in EudraCT
    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 No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state46
    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 Decision2007-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-06
    P. End of Trial
    P.End of Trial StatusCompleted
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