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    The EU Clinical Trials Register currently displays   43889   clinical trials with a EudraCT protocol, of which   7298   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2011-006319-69
    Sponsor's Protocol Code Number:1.0
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-02-22
    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 number2011-006319-69
    A.3Full title of the trial
    Closed abdomen hyperthermic intraperitoneal chemotherapy with paclitaxel for advanced epithelial ovarian cancer
    QUIMIOHIPERTERMIA INTRAPERITONEAL CON PACLITAXEL MEDIANTE TÉCNICA CERRADA EN EL CÁNCER DE OVARIO AVANZADO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ovarian cancer treatment with intraabdominal chemotherapy (paclitaxel)
    tratamiento del cancer de ovario con quimioterapia (paclitaxel) intraabdominal
    A.3.2Name or abbreviated title of the trial where available
    Hipecovario
    Hipecovario
    A.4.1Sponsor's protocol code number1.0
    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 SponsorPedro Villarejo Campos(Hospital Universitario Ciudad Real)
    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 supportgalmaz biotech
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationunidad de investigacion (hospital universitario de ciudad real)
    B.5.2Functional name of contact pointsecretaria unidad de investigacion
    B.5.3 Address:
    B.5.3.1Street Addressc/Obispo Rafael Torija
    B.5.3.2Town/ cityciudad real
    B.5.3.3Post code13005
    B.5.3.4CountrySpain
    B.5.4Telephone number0034926278000
    B.5.5Fax number0034926278540
    B.5.6E-maileseguram@sescam.jccm.es
    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 paclitaxel teva
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Pharma - Produtos Farmacêuticos, Lda., Porto Salvo, Portugal
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Concentrate for solution for infusion
    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.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 cancer (II,III,IV FIGO staging and tumoral recurrence)
    Cancer de ovario en estadio II,III,IV de la FIGO y recurrencia tumoral
    E.1.1.1Medical condition in easily understood language
    advanced ovarian cancer
    cancer de ovario avanzado
    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 LLT
    E.1.2Classification code 10028584
    E.1.2Term Myelosuppression
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10006093
    E.1.2Term Bradycardia
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10028813
    E.1.2Term Nausea
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10012727
    E.1.2Term Diarrhea
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10047700
    E.1.2Term Vomiting
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10028127
    E.1.2Term Mucositis
    E.1.2System Organ Class 10018065 - General disorders and administration site conditions
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10003239
    E.1.2Term Arthralgia
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10001760
    E.1.2Term Alopecia
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10046544
    E.1.2Term Urinary infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10021097
    E.1.2Term Hypotension
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10028411
    E.1.2Term Myalgia
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10038700
    E.1.2Term Respiratory infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10034610
    E.1.2Term Peripheral neuropathy NOS
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assessment of therapeutic efficacy of closed abdomen hyperthermia intraperitoneal chemotherapy with paclitaxel in advanced ovarian cancer or tumoral recurrences
    Valoración de la eficacia terapeútica de la administración intraperitoneal de paclitaxel mediante quimiohipertermia cerrada en pacientes con cáncer de ovario avanzado o recidivado.
    E.2.2Secondary objectives of the trial
    To measure adverse effects and complications in patients who applies closed abdomen hyperthermia intraperitoneal chemotherapy with paclitaxel.
    -To compare the morbidity and mortality of closed abdomen hyperthermia intraperitoneal chemotherapy in relation to morbidity and mortality reported in the literature for open abdomen hyperthermia intraperitoneal chemotherapy of advanced ovarian cancer
    Evaluar los efectos adversos y complicaciones en los pacientes a los que se aplica quimiohipertermia intraabdominal cerrada con paclitaxel.
    -Comparar la morbilidad y mortalidad de la quimiohipertermia cerrada con paclitaxel en relación con la morbilidad y mortalidad recogida en la literatura para la quimiohipertermia abierta en el tratamiento del cáncer de ovario avanzado.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Women over 18 years with histologically confirmed epithelial ovarian cancer stage II / III / IV (FIGO staging) or tumoral recurrences.
    -Complete debulking / optimal: Index CC0/CC1 cytoreduction (residual tumor size after surgery, no visible (CC0) or less than 0.25 cm (CC1))
    -No extra-abdominal tumor disease
    -Absence of heart failure, kidney or liver.
    -The treatment should be scheduled at least 1 month after the last administration of systemic chemotherapy.
    -Women have given their consent to participate in the study.
    Mujeres mayores de 18 años con diagnóstico histológico de cáncer epitelial de ovario estadio II/III/IV o recurrente.
    Citorreducción completa/óptima: Índice de citorreducción CC0/CC1 (tamaño tumoral residual después de la cirugía, no visible (CC0) o inferior a 0,25 cm (CC1))
    Ausencia de enfermedad tumoral extraabdominal
    Ausencia de insuficiencia cardiorrespiratoria, renal o hepática.
    El tratamiento multidisciplinar debe ser programado al menos 1 mes después de la administración de la última quimioterapia sistémica.
    Que hayan otorgado su consentimiento para participar en el estudio.
    E.4Principal exclusion criteria
    -Patients who have unresectable peritoneal carcinomatosis or those who can not complete optimal cytoreduction.
    -Extrabdominales metastases or unresectable liver metastases or involve a major hepatectomy what conditions a limited hepatic reserve.
    -Presence of other malignant tumor disease.
    -Multisegmental complete bowel obstruction.
    -Active infection or other condition that incapacitate for treatment according to the protocol proposed.
    -No specific acceptance of informed consent for this treatment.
    Pacientes que presentan una carcinomatosis peritoneal irresecable o aquellas en las que no se consigue una citorreducción completa u óptima.
    Metástasis extrabdominales o metástasis hepáticas no resecables o que impliquen una hepatectomía mayor que condicione una reserva hepática muy limitada.
    Imposibilidad de un seguimiento adecuado del paciente.
    Presencia de otra enfermedad tumoral maligna.-
    Obstrucción intestinal completa multisegmentaria.
    Infección activa u otra condición que impida o incapacite al paciente para recibir el tratamiento propuesto según el protocolo.
    No aceptación del consentimiento informado específico para este tratamiento.
    E.5 End points
    E.5.1Primary end point(s)
    -Overall survival and progression-free survival
    -Supervivencia global y supervivencia libre de enfermedad
    E.5.1.1Timepoint(s) of evaluation of this end point
    The trial design included 94 patients. The study is presented in two steps, a first step would include the first 40 patients. So when patients grade 3 complications exceeds from 40% and / or grade 4 complications exceeds from 20% and / or mortality exceeds from 10% of the study should be stopped.
    El diseño del estudio engloba a 94 pacientes durante dos años de inclusión y un seguimiento de tres años. El estudio está planteado en dos pasos, un primer paso englobaría a los 40 primeros pacientes. De tal forma que si en los pacientes sometidos a quimiohipertermia cerrada, las complicaciones grado 3 excede del 40 % y/o las complicaciones grado 4 superan el 20% y/o la mortalidad excede el 10% el estudio
    E.5.2Secondary end point(s)
    NO
    E.5.2.1Timepoint(s) of evaluation of this end point
    NO
    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 No
    E.6.5Efficacy No
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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
    THE END OF THE TRIAL WILL BE THE LAST VISIT OF THE LAST SUBJECT UNDERGOING TRIAL
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 79
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 Yes
    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 2012-02-22. Yes
    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 state89
    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)
    there will be not any difference from the expected normal treatment in this condition (ovarian cancer)
    no habrá ninguna diferencia en el tratamiento con las pacientes intervenidas por cancer de ovario,respecto a los protocolos habituales.
    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 Decision2012-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-26
    P. End of Trial
    P.End of Trial StatusOngoing
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