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    The EU Clinical Trials Register currently displays   38002   clinical trials with a EudraCT protocol, of which   6235   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2005-004139-23
    Sponsor's Protocol Code Number:62202-677
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-03-30
    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 ConcernedGermany - PEI
    A.2EudraCT number2005-004139-23
    A.3Full title of the trial
    An open-label, non-randomized phase I/II trial of neoadjuvant radio-immunochemotherapy with
    cetuximab and 5-FU for advanced rectal cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    neoadjuvant radio-immunochemotherapy with
    cetuximab and 5-FU for advanced rectal cancer
    A.4.1Sponsor's protocol code number62202-677
    A.5.4Other Identifiers
    Name:RACENumber:2005-004139-23
    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 SponsorUniversity of Cologne
    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 supportUniversity of Cologne
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Cologne
    B.5.2Functional name of contact pointDr. Robert Semrau
    B.5.3 Address:
    B.5.3.1Street AddressKerpener Strasse 62
    B.5.3.2Town/ cityCologne
    B.5.3.4CountryGermany
    B.5.4Telephone number+492214785449
    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 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 nameCetuximab
    D.3.2Product code EMD271786
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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) No
    D.3.11.7Plasma derived medicinal product Yes
    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 typemonoclonal antibody
    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 adenocarcinoma of the rectum
    E.1.1.1Medical condition in easily understood language
    rectum cancer
    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
    Phase I part of the trial: define the safe dose of infusional 5-FU in combination with Cetuximab and RT in this
    setting
    Phase II part of the trial: Assessment of the pathological complete response (pCR)
    E.2.2Secondary objectives of the trial
    Assessment of treatment related toxicities
    Assessment of the frequency of sphincter-preserving surgery
    Assessment of R0-resection rate
    Assessment of overall pathological response rate (pCR + pPR)
    Assessment of Recurrence of disease in FU
    E.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Signed written informed consent
    • Male or female > 18 years of age
    • Histologically proven locally advanced adenocarcinoma of the rectum (T3, T4, any nodal stage) with the
    inferior margin of the tumor being no farther than 16 cm from the anal verge
    • Surgical resectability or possible sphincter preservation after neoadjuvant treatment
    • ECOG Performance Status < 2
    • Adequate bone marrow function: leucocytes > 3.0 x 109/L, neutrophils > 1.5 x 109/L, platelets > 100 x 109/L,
    hemoglobin > 10.0 g/dL
    • Adequate liver function: Bilirubin < 2.0 mg/dL, SGOT, SGPT, AP, gamma-GT < 3 x ULN
    • Adequate renal function: serum creatinine < 1.5 mg/dL, creatinine clearance > 50 ml/min (calculated value
    according to Cockroft-Gault equation)
    • If of childbearing potential, willingness to use effective contraceptive method for an adequate period of time.
    E.4Principal exclusion criteria
    • Prior pelvic radiotherapy
    • Prior chemotherapy
    • Presence of distant metastases
    • Clinically relevant coronary artery disease or a history of myocardial infarction within the last 12 months or left
    ventricular ejection fraction (LVEF) below the institutional range of normal
    • Other chronic bowel disease (malabsorption, inflammatory bowel disease, acute or subacute intestinal
    occlusion)
    • Prior exposure to EGFR pathway targeting therapy
    • Having participated in another clinical trial or any investigational agent in the preceding 30 days
    • Any active dermatological condition > Grade 1
    • Known allergic/hypersensitivity reaction to any of the components of the treatment
    • Pregnancy (absence confirmed by serum/urine �-HCG) or breast-feeding
    • Known drug abuse/alcohol abuse
    • Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the
    skin or pre-invasive carcinoma of the cervix
    • Legal incapacity or limited legal capacity
    • Medical or psychological condition which in the opinion of the investigator would not permit the patient to
    complete the study or sign meaningful informed consent
    E.5 End points
    E.5.1Primary end point(s)
    Within the phase I part of the trial, the Dose-Limiting Toxicity is the primary safety parameter.
    For quantification of efficacy within the second part of the trial, the primary objective is the pathological
    response, defined as complete response as determined by the pathologist at surgery.
    E.5.1.1Timepoint(s) of evaluation of this end point
    DLT are assessed from treatment start (day 1) until 10 days following completion of
    radiochemotherapy (= day 48).
    For quantification of efficacy within the second part of the trial, the primary objective is the pathological
    response, defined as complete response as determined by the pathologist at surgery.
    E.5.2Secondary end point(s)
    Assessment of treatment related toxicities
    Assessment of the frequency of sphincter-preserving surgery
    Assessment of R0-resection rate
    Assessment of overall pathological response rate (pCR + pPR)
    Assessment of Recurrence of disease in FU
    E.5.2.1Timepoint(s) of evaluation of this end point
    Treatment phase and / or Follow-Up phase
    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 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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    safe dose of infusional 5-FU in combination with Cetuximab and RT
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial0
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 trial is defined as the end FU of the last patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months0
    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) Information not present in EudraCT
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    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 Yes
    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 state57
    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)
    Following the end of treatment evaluation or end of treatment for any other cause, patients
    will be treated and followed according to the guidelines of the German Cancer Society.
    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 Decision2006-04-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-08-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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