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    Summary
    EudraCT Number:2004-002803-34
    Sponsor's Protocol Code Number:Cetcapox-RT_31.08.2004
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-11-25
    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 ConcernedGermany - PEI
    A.2EudraCT number2004-002803-34
    A.3Full title of the trial
    Phase I/II-Studie
    Praeoperative Radiochemotherapie mit Capecitabin plus Oxaliplatin und Cetuximab beim lokal fortgeschrittenen Rektumkarzinom im UICC-Stadium II und III
    A.3.2Name or abbreviated title of the trial where available
    Cetcapox-RT
    A.4.1Sponsor's protocol code numberCetcapox-RT_31.08.2004
    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 SponsorKlinik und Poliklinik fuer Strahlentherapie, Universität Erlangen-Nürnberg
    B.1.3.4CountryGermany
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Erbitux
    D.2.1.1.2Name of the Marketing Authorisation holderMerck KGaA
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameErbitux
    D.3.2Product code EMD271786
    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.3.11 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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.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 Information not present in EudraCT
    D.2.1.1.1Trade name Xeloda
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 N/A
    D.3.4Pharmaceutical form Film-coated tablet
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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.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 Information not present in EudraCT
    D.2.1.1.1Trade name Eloxatin
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Synthelabo
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameOxaliplatin
    D.3.2Product code -
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    Rektumkarzinom
    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
    Die Phase-I/II-Studie soll Effektivität und Tolerabilität einer innovativen Chemotherapie mit einem oralen 5-FU-Derivat (Capecitabin, i.f. Cap) plus Oxaliplatin (i.f. Ox) in Verbindung mit dem EGFR-Antikörper Cetuximab im Rahmen d. präop. RT/CT d. lokal fortgeschrittenen Rektumkarzinoms untersuchen. In Phase I wird getestet, ob die Hinzunahme von Cetuximab zu dem etablierten RT/CT-Konzept mit Cap und Ox durchführbar ist. Aus Sicherheitsgründen wird zunächst die Dosierung des Cap auf 1000 mg/m² (d1-14, d22-35) reduziert. Cap wird in Kohorten zu 3 Pat. in insgesamt 3 Stufen (1000 mg/m², 1300 mg/m², 1650 mg/m²) eskaliert. Treten bei 2/3 oder 2/6 Pat. DLTs auf, ist die MTD erreicht. Treten in der Dosisstufe 3 keine DLTs bzw. nicht mehr als bei 1/6 DLTs auf, wird diese Dosisstufe in der Phase II verwendet. Ansonsten wird die Dosisstufe der nächstniedrigeren Cap-Dosis als empfohlene Dosis für die Phase-II-Studie verwendet. Endpunkt der Phase-II ist die Rate an kompletten Remissionen.
    E.2.2Secondary objectives of the trial
    • Bestimmung der akuten und chronischen Toxizität der präoperativen Radiochemotherapie (RCT) in Verbindung mit dem Antikörper Cetuximab sowie der operativen Morbidität
    • Durchführbarkeit (Compliance) der Gesamttherapie (Radiochemotherapie + Cetuximab)
    • Rate an histopathologischem Downstaging
    • Ermittlung der Häufigkeit sphinktererhaltender Operationsverfahren bei tiefsitzenden Tumoren
    • R0-Resektionsrate
    • Ermittlung der Lokalrezidivrate
    • Ermittlung der Fernmetastasenrate
    • Ermittlung der Überlebenszeit
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Alter mindestens 18 Jahre
    2. Histologisch gesichertes, fortgeschrittenes primäres Rektumkarzinom bis 16 cm von der Anokutanlinie, uT3-4 und/oder uN+ oder Mason III/IV mit oder ohne synchroner Fernmetastasierung.
    3. Der immunhistochemische Nachweis der EGF-Rezeptorpositivität des Tumors ist nach neuesten Daten nicht zwingend notwendig.
    4. Keine Vorbehandlung außer primärer Anus praeter-Anlage (z.B. wegen drohendem Ileus)
    5. ECOG-Status < 2
    6. Ausreichende Knochenmarkfunktion:
    Leukozyten > 3,5 x 109/L
    Neutrophile > 1,5 x 109/L
    Thrombozyten > 100 x 109/L
    Hämoglobin > 10 g/dl
    7. Ausreichende Leberfunktion:
    Bilirubin ≤ 1,5 mg/dl
    SGOT, SGPT, AP, Gamma-GT < des 2-fachen des oberen Grenzwertes des Normbereichs
    8. Serumkreatinin < 1,5 mg/dl, Kreatinin-Clearance > 50 ml/min
    9. Patienten, die die Inhalte des Protokolls verstanden und schriftlich ihr Einverständnis zur Teilnahme erklärt haben.
    E.4Principal exclusion criteria
    1. Schwangere oder stillende Frauen
    2. Gebär- bzw. zeugungsfähige Menschen, die nicht zu konsequenten Verhütungsmaßnahmen während der Therapie willens oder in der Lage sind.
    3. Zurückliegender oder andauernder Drogen-, Medikamenten- oder Alkoholmißbrauch
    4. Frühere Chemotherapie oder Therapie mit einem EGFR-Inhibitor
    5. Frühere Radiotherapie des Beckens
    6. Gleichzeitige oder innerhalb von 4 Wochen liegende Teilnahme an einer anderen Studie mit einem oder mehreren in Erprobung befindlichen Medikamenten.
    7. Gleichzeitige Therapie mit anderen Antitumormitteln
    8. Patienten, die nicht in der Lage oder bereit sind, sich protokollgerecht zu verhalten und behandeln sowie nachuntersuchen zu lassen.
    9. Patienten mit unkontrollierten schwerwiegenden, körperlichen oder geistigen Erkrankungen, wie z.B.:
    - Instabile kardiale Erkrankung trotz medikamentöser Behandlung, Myokardinfarkt innerhalb der letzten 6 Monate vor Studienbeginn
    - Neurologische oder psychiatrische Störungen einschließlich Demenz und Anfallsleiden
    - Aktive, nicht-kontrollierbare Infektion oder Sepsis
    - Aktive disseminierte intravasale Gerinnungsstörung
    10. Symptomatische periphere Neuropathie NCI-CTC Grad > 2
    11. Patienten mit Zweitmalignomen mit Ausnahme des Basalzellkarzinoms der Haut oder des Carcinoma in situ der Zervix, welche erfolgreich behandelt worden sind. Der Einschluss von Patienten mit anderen Tumoren, die erfolgreich behandelt wurden und innerhalb der letzten 5 Jahre nicht wieder aufgetreten sind, muss mit der Studienleitung (LKP) diskutiert werden.
    12. Chronische Diarrhoe (> NCI CTC-Grad 1)
    13. Chronisch entzündliche Darmerkrankungen andere Störungen, die die Medikamentenresorption beeinträchtigen. Dazu zählen das Dumping-Syndrom, Hinweise auf beschleunigte Dünndarmpassage, Hinweise auf Resorptionsstörungen nach Magen- oder Darmoperationen
    14. Überempfindlichkeit gegenüber platinhaltigen Substanzen
    15. Bekannte Grad 3/4 allergische Reaktion gegenüber monoklonalen Antikörpern
    16. Gleichzeitige Behandlung mit Sorivudin und Analoga
    17. Bekannte Defizienz der Dehydropyrimidindehydrogenase (DPD)
    E.5 End points
    E.5.1Primary end point(s)
    • Phase I: Definition der empfohlenen Dosis von Capecitabin in Kombination mit fixen Dosen von Oxaliplatin und Cetuximab und Radiotherapie
    • Phase II: Häufigkeit histopathologisch kompletter Remissionen
    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 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) Yes
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Therapieoptimierungsstudie
    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 No
    E.8.1.2Open Yes
    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.8.5The 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 Information not present in EudraCT
    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 years3
    E.8.9.1In the Member State concerned months3
    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 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 2004-11-25. 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 state58
    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)
    Operation, adjuvante Chemotherapie und Nachsorgeuntersuchungen nach den Empfehlungen der Dt. Krebsgesellschaft
    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 Decision2004-12-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-11-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-11-01
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