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    Summary
    EudraCT Number:2007-002053-24
    Sponsor's Protocol Code Number:07_DOG03_133
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-10-10
    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 ConcernedUK - MHRA
    A.2EudraCT number2007-002053-24
    A.3Full title of the trial
    A phase II study evaluating the use of concurrent cetuximab, irinotecan, oxaliplatin and UFT in the first line treatment of patients with metastatic colorectal cancer
    A.3.2Name or abbreviated title of the trial where available
    e-SCOUT
    A.4.1Sponsor's protocol code number07_DOG03_133
    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 SponsorThe Christie NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 Yes
    D.2.1.1.1Trade name Erbitux 5mg/ml
    D.2.1.1.2Name 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.3.2Product 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 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.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, inoperable or metastatic colorectal cancer.
    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
    To demonstrate the response rate (RR), using the RECIST criteria, of patients with locally advanced / metastatic colorectal cancer treated with a combination of irinotecan, oxaliplatin, UFT and cetuximab.
    E.2.2Secondary objectives of the trial
    To assess:
    - Progression-free survival (PFS)
    - Overall survival (OS; all causes of death)
    - Toxicity
    - Resectability of liver, lung and pelvic disease after chemotherapy
    - Time to progression (TTP)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A phase II study evaluating the use of concurrent cetuximab, irinotecan, oxaliplatin and UFT in the first line treatment of patients with metastatic colorectal cancer
    Translational Research Protocol
    version 1.7 - 4th January 2010.

    Aims:
    - To evaluate circulating levels of VEGF, soluble KDR and FGF-7, apoptotic biomarkers, CTCs and KRAS and PI-3K mutations in circulating free DNA as predictive factors of response to chemotherapy.
    - To evaluate KRAS and PI-3K expression in primary tumour biopsy specimens and post chemotherapy resected specimens, EGFR overexpression, Ki-67 expression, cleaved caspase 3 and cleaved CK 18 as predictive factors for response to Cetuximab administered with chemotherapy.
    E.3Principal inclusion criteria
    - Histologically confirmed colorectal adenocarcinoma
    - Patients must not have a mutation of K-ras
    - Inoperable metastatic or locoregional disease
    - No previous chemotherapy for established metastatic disease (adjuvant chemotherapy must have been completed > 6 months prior to trial entry.
    - Measurable / evaluable disease
    - Normal haematology
    - Adequate renal function
    - Adequate liver funtion
    - Karnofsky performance status 70-100
    - Negative pregnancy test for women of child-bearing potential
    - Patients must give written, informed consent
    - Life expectancy of at least 3 months
    E.4Principal exclusion criteria
    - Patients that have a K-ras mutation
    - Concurrent uncontrolled medical illness, or other previous / current malignant disease likely to interfere with protocol treatments or comparisons
    - Partial / complete bowel obstruction
    - Prior EFGR therapy
    - Age < 18
    - Chronic diarrhoea or inflammatory bowel disease
    - Known DPD deficiency
    - Gilbert's syndrome or other congenital abnormality of biliary transport
    - Previous translant surgery requiring immunosuppressive therapy
    - Regular / uncontrolled angina or cardiac arrhythmias
    - Clinically relevant coronary heart disease. History of myocardial infarction in last 12 months
    - Previous investigational agent in last 4 weeks
    - Metastatic disease to brain
    - Pregnant/lactating women
    - Patients receiving therapy with haloginated antiviral drugs
    - Patients who have experienced life-threatening toxicities with fluoropyrimidines
    - Patients suffering from any conditions which may affect absorption of UFT / folinic acid
    - Patients with known deficiency of or are on inhibitors of cytochrome P450 2A6
    - Patients who have previously had radiotherapy to the abdomen / pelvis in last 6 months
    - Any medical / psychological condition that in the opinion of the investigator would not enable the patient to complete the study or knowingly give informed consent
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point is the objective response rate as measured by RECIST criteria. Chemotherapy should be given for 8 weeks (2 cycles) prior to assessment.
    - In patients who respond or develop stable disease, the treatment should be continued for a further 8 weeks (16 weeks in total).
    - In patients who respond or develop stable disease, the treatment should be continued for a further 8 weeks (24 weeks in total).
    - If a patient contiunes to respond or maintain stable disease after 24 weeks of treatment, then the treatment can be contiunued until disease progression (if cumulative toxicity is not a problem) at the discretion of the investigator in agreement with the individual patient.
    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 Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned5
    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 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
    The last treatment 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 years2
    E.8.9.1In the Member State concerned months6
    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.1.3Elderly (>=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.4.2.2In the whole clinical trial 50
    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 Decision2007-10-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-05-15
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