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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43691   clinical trials with a EudraCT protocol, of which   7244   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2007-001200-20
    Sponsor's Protocol Code Number:CSET 1287
    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:2007-09-07
    Trial results
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2007-001200-20
    A.3Full title of the trial
    A multicenter randomized phase II Trial assessing the activity of Gemcitabine - Oxaliplatin chemotherapy alone or in combination with Cetuximab in patients with advanced biliary cancer
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberCSET 1287
    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 SponsorMedizinische Hochschule Hannover
    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.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
    B.Sponsor: 2
    B.1.1Name of Sponsor
    B.3.1 and B.3.2Status of the sponsor
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    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. name Erbitux 5mg/ml
    D. of the Marketing Authorisation holderMerck KgaA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical 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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcetuximab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 Yes
    D. 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
    adenocarcinoma of the biliary tract ( gallbladder, intra and/ or extrahepatic bile ducts, ampulla of Vater)
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of treatment efficacy by assessing the crude progression-free survival (PFS) rate at 4 months
    E.2.2Secondary objectives of the trial
    1.Toxicity graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 3.0) and to the Levi’s specific scale for peripheral neuropathy. 2.Objective tumor response rate (RECIST). 3.Disease control rate (RECIST). 4.PFS and OS. CRITERIA FOR EXPLORATORY ANALYSES: 5.Early metabolic tumor response (DSUVmax on FDG-PET within 4 weeks before the beginning of the treatment and repeated at 4 weeks) will be correlated to therapeutic response (assessed by CT scan at 2, 4 and 6 months), OS and PFS. 6.Predictive value of cetuximab-induced skin reactions (i.e., occurrence and severity) on treatment efficacy. 7.Functional or molecular alterations of EGFR pathway, predictive of the tumor response (or absence of response) to cetuximab in ABC, including detection of EGFR and KRAS mutations, detection of EGFR and HER2 gene amplification, tumor expression of EGFR, IGF-1R, HER2, HER3, phospho-Akt, detection of truncated HER2 and EGFR in serum
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Adenocarcinoma of the biliary tract (gallbladder, intra and/or extrahepatic bile ducts, or ampulla of Vater):· Cytologically or histologically confirmed. In case of uncertain biliary tract origin (e.g., intrahepatic, peripheral cholangiocarcinomas), inclusion is possible if i) extensive search for primary (thoracic and abdominopelvic CT scan, colonoscopy, upper digestive endoscopy, serum PSA level for men or mammography for women, and Fluorodesoxyglucose-Positron Emission Tomography if possible) is negative; and ii) histological examination is consistent with bile duct adenocarcinoma (Imunohistochemistry should ideally be performed and be consistent with biliary primary, e.g., positive for cytokeratin 7 and 19 and negative for cytokeratin 20).· - Not amenable to curative resection, or recurrent after resection (i.e., locally advanced or metastatic),· - With at least one unidimensionally measurable target lesion in a non-irradiated, non-PhotoDynamic Therapy-treated area (longest diameter ≥1 cm [spiral Computed Tomography scan]) or ≥2 cm [conventional CT scan]),· With biliary obstruction controlled, 2.Age between 18 and 75 years. 3.World Health Organization (WHO) performance status of 0 or 1. 4.Life expectancy higher than 3 months. 5.No prior chemotherapy for advanced disease. Previous adjuvant chemotherapy is allowed (completed at least ≥ 6 months previously, if containing gemcitabine or platinum salts). Previous irradiation (external radiotherapy, brachytherapy) and Photo Dynamic Therapy are allowed provided that there is at least one unidimensionally measurable target lesion in untreated area. 6.Bilirubin ≤ 3 times the upper limit of the normal range (ULN). Pts with jaundice or evidence of bile duct obstruction, in whom the biliary tree can be decompressed by endoscopic or percutaneous endoprothesis with subsequent reduction in bilirubin ≤ 3 ULN, will be eligible for the study. 7. Aminotransferases (AST, ALT) ≤ 5 ULN, INR < 1.5 (following vitamin K1 injection in pts with current or recent history of jaundice or bile duct obstruction), creatinine ≤ 1.5 ULN, neutrophils ≥ 1.5 10^9/L, platelets ≥ 100 10^9/L, hemoglobin ≥ 9 g/dL (red blood cell transfusion if needed is allowed). 8.Written informed consent. Note: EGFR tumor status has to be known for every patient, but it is neither an inclusion/exclusion criterion nor a stratification factor. EGFR expression has to be assessed by Immunohistochemistry using biopsy or surgical material, at any time prior to inclusion into the study
    E.4Principal exclusion criteria
    1.Known central nervous system metastases. 2.Contraindication or history of grade 3-4 allergy reaction to one treatment component. 3.Surgery (except diagnostic biopsy), external radiotherapy, brachytherapy, or Photodynamix Therapy within 30 days prior to start of treatment. Prior adjuvant chemotherapy is only allowed if completed at least 30 days previously (6 months if containing gemcitabine or platinum salts). 4.Participation in another clinical trial within 30 days prior to start of treatment. 5.Concomitant systemic chronic immunotherapy, chemotherapy, or antitumor hormone therapy. 6.Previous administration of EGFR inhibitors or EGF. 7.Active uncontrolled infection, peripheral neuropathy ≥ grade 2, acute or subacute bowel obstruction or history of inflammatory bowel disease, symptomatic coronary disease or myocardial infarction in the past 6 months, congestive heart failure (≥ NYHA class II), interstitial pneumonitis or respiratory failure, or renal failure. 8.Pregnancy (or positive bêta-HCG dosage at baseline), breast-feeding, or lack of effective contraception in male or female patients of reproductive potential. 9.Other malignancies either currently active or in the last 5 years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma. 10.Legal incapacity or physical, psychological or mental status interfering with the patients ability to terminate the study or to sign the informed consent
    E.5 End points
    E.5.1Primary end point(s)
    PRIMARY CRITERION: crude Progression-Free Survival rate at 4 months according to RECIST (Response Evaluation Criteria in Solid Tumors).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    functional imaging (PET)- prognostic/predictive factor identification
    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. 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) Yes
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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 Yes
    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
    Patient's follow-up will be pursued every 2 months until patient's death
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months36
    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 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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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 Decision2007-12-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-07-27
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