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    Summary
    EudraCT Number:2014-002850-38
    Sponsor's Protocol Code Number:PI-0327-2013
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-10-16
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2014-002850-38
    A.3Full title of the trial
    EFFICACY AND SAFETY OF EARLY POSTOPERATIVE CHEMOTHERAPY INTRAPERITONEAL (EPIC) WITH PACLITAXEL IN THE RADICAL SURGERY TREATMENT OF OVARIAN PERITONEAL CARCINOMATOSIS
    EFICACIA Y SEGURIDAD DE LA QUIMIOTERAPIA INTRAPERITONEAL POSTOPERATORIA PRECOZ (EPIC) CON PACLITAXEL EN EL TRATAMIENTO QUIRÚRGICO RADICAL DE LA CARCINOMATOSIS PERITONEAL OVÁRICA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the benefit and safety of a drug, paclitaxel, in the treatment of advanced ovarian cancer by applying intraperitoneally for three hours a day in the days following surgery, in which disease malignant ovarian tumor was removed and chemotherapy was administered hyperthermic intraoperative intraperitoneally.
    Estudio para evaluar el beneficio y la seguridad de un medicamento, paclitaxel, en el tratamiento del cáncer de ovario avanzado aplicándolo intraperitonealmente durante tres horas diarias en los días siguientes a la cirugía, en la que se extirpó la enfermedad tumoral maligna ovárica y se administró quimioterapia intraperitoneal intraoperatoria hipertérmica.
    A.4.1Sponsor's protocol code numberPI-0327-2013
    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 SponsorFUNDACIÓN PARA LA INVESTIGACIÓN BIOMÉDICA DE CÓRDOBA
    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 supportJunta de Andalucía
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFUNDACIÓN PARA LA INVESTIGACIÓN BIOMÉDICA DE CÓRDOBA
    B.5.2Functional name of contact pointUNIDAD ENSAYOS CLÍNICOS
    B.5.3 Address:
    B.5.3.1Street AddressAvenida Menéndez Pidal s/n
    B.5.3.2Town/ cityCórdoba
    B.5.3.3Post code14004
    B.5.3.4CountrySpain
    B.5.4Telephone number+34957011266
    B.5.5Fax number+34957736149
    B.5.6E-mailisabel.bejerano@imibic.org
    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 Taxol
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE LIMITED
    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 Intraperitoneal solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraperitoneal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    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
    ovarian peritoneal carcinomatosis
    carcinomatosis peritoneal ovárica
    E.1.1.1Medical condition in easily understood language
    advanced ovarian cancer
    cáncer de ovario avanzado
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the efficacy and safety of early postoperative intraperitoneal chemotherapy (EPIC) with paclitaxel after radical peritonectomy and intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with ovarian peritoneal carcinomatosis
    Evaluar la eficacia y seguridad de la quimioterapia intraperitoneal postoperatoria precoz (EPIC) con paclitaxel tras peritonectomía radical y quimioterapia intraperitoneal intraoperatoria hipertérmica (HIPEC) en pacientes con carcinomatosis peritoneal ovárica
    E.2.2Secondary objectives of the trial
    1) Evaluate morbility (Dindo-Clavien scale) of EPIC in the 3-day treatment group versus no EPIC
    2) Evaluate morbility associated with the two treatment regimens in terms of myelosuppression and the need for blood transfusion or colony stimulating factors, and possible relative to the plasma levels of paclitaxel
    3) Evaluate paclitaxel plasma concentrations reached in the two treatment groups
    4) Evaluate response of the tumor marker Ca 125 after optimal cytoreduction R0 in the two treatment groups applied
    5) Analyze hospital stay and time to full recovery of routine physical activity in the two treatment groups
    6) Analyze postoperative mortality, and disease free survival
    7) Analyze possible prognostic factors for survival
    1) Evaluar la morbilidad (escala de Dindo-Claviende) de EPIC, 3 días de tratamiento, frente no EPIC
    2) Evaluar la morbilidad asociada a los dos esquemas de tratamiento en términos de mielosupresión y necesidad de transfusión de hemoderivados o factores de estimulación de colonias, y su posible
    relación con los niveles plasmáticos de paclitaxel
    3) Evaluar las concentraciones plasmáticas de paclitaxel alcanzadas en los dos grupos de tratamiento
    4) Evaluar respuesta del marcador tumoral Ca 125 tras la citorreducción óptima R0 en los dos grupos de tratamiento aplicado
    5) Analizar tiempo de estancia hospitalaria y tiempo de recuperación completa de la actividad física rutinaria en los dos grupos de tratamiento
    6) Analizar mortalidad postoperatoria, tiempo libre de enfermedad y supervivencia
    7) Analizar posibles factores pronósticos de supervivencia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Women, aged > 18 and < 65 years
    2) Epithelial ovarian peritoneal carcinomatosis (FIGO stage III c) of
    primary or recurrent diagnosis
    3) Radical cytoreductive surgery with HIPEC procedures peritonectomy and achieving optimal cytoreduction without macroscopic residue (R0)
    4) Body mass index (BMI) ? 30
    5) Classification ASA (American Society of Anesthesiologists) I-II
    6) Karnofsky Index> 70 or performance status <2
    7) Informed consent duly completed
    1) Mujer de edad >18 años y < 65 años
    2) Carcinomatosis peritoneal epitelial ovárica (estadio IIIc FIGO) de
    diagnóstico primario o recurrente
    3) Cirugía citorreductora radical con procedimientos de peritonectomía e HIPEC alcanzando citorreducción óptima sin residuo macroscópico (R0)
    4) Índice de masa corporal (IMC) ? 30
    5) Clasificación ASA (American Society of Anesthesiologist) I-II
    6) Índice de Karnofsky >70 o Performance status<2
    7) Consentimiento informado debidamente cumplimentado
    E.4Principal exclusion criteria
    1) Not meeting the inclusion criteria
    2) Presence of distant metastases or stage IV FIGO
    3) Coexistence of other malignant neoplasm
    4) Hepatic, renal or cardiovascular function altered
    5) More than 2 previous intravenous chemotherapy schemes
    6) Have received prior chemotherapy except intraperitoneal-diagnostic staging laparoscopy
    7) More than 2 previous surgical interventions ovarian neoplasia
    8) More than 2 complete bowel anastomosis
    9) Treatment intolerance
    10) Waiver of the patient to participate in the study
    1) No cumplimiento de los criterios de inclusión
    2) Presencia de metástasis a distancia o estadio IV FIGO
    3) Coexistencia de otra enfermedad neoplásica maligna
    4) Función hepática, renal o cardiovascular alteradas
    5) Más de 2 esquemas de quimioterapia intravenosa previa
    6) Haber recibido quimioterapia intraperitoneal previa excepto en laparoscopia diagnóstica-estadiaje
    7) Más de 2 intervenciones quirúrgicas previas relacionadas con la neoplasia ovárica
    8) Más de 2 anastomosis intestinales completas
    9) Intolerancia al tratamiento
    10) Renuncia de la paciente a participar en el estudio
    E.5 End points
    E.5.1Primary end point(s)
    Global survival time
    Tiempo de supervivencia global
    E.5.1.1Timepoint(s) of evaluation of this end point
    Hospital discharge, 30 days, 90 days, 180 days, 360 days, 540 days, 720 days
    Alta hospitalaria, 30 días, 90 días, 180 días, 360 días, 540 días, 720 días
    E.5.2Secondary end point(s)
    - Morbility and mortality postoperative
    - Disease-free time
    - Morbilidad y mortalidad postoperatoria
    -Tiempo libre de enfermedad
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Morbility and mortality postoperative : hospital discharge
    - Disease-free time: hospital discharge, 30 days, 90 days, 180 days, 360 days, 540 days, 720 days
    - Morbilidad y mortalidad postoperatoria: alta hospitalaria
    -Tiempo libre de enfermedad: alta hospitalaria, 30 días, 90 días, 180 días, 360 días, 540 días, 720 días
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 Yes
    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
    No EPIC
    No EPIC
    E.8.2.4Number of treatment arms in the trial2
    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.8.5The 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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: 60
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state60
    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)
    None
    Ninguno
    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 Decision2015-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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