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    Summary
    EudraCT Number:2006-003121-82
    Sponsor's Protocol Code Number:4351
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-10-31
    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 number2006-003121-82
    A.3Full title of the trial
    A prospective randomised open label trial of oxaliplatin / irinotecan plus fluorouracil versus oxaliplatin / irinotecan plus fluorouracil and cetuximab pre and post operatively in patients with resectable colorectal liver metastases requiring chemotherapy.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A prospective randomised open label trial of oxaliplatin / irinotecan plus fluorouracil versus oxaliplatin / irinotecan plus fluorouracil and cetuximab pre and post operatively in patients with resectable colorectal liver metastases requiring chemotherapy.
    A.3.2Name or abbreviated title of the trial where available
    New EPOC
    A.4.1Sponsor's protocol code number4351
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN22944367
    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 SponsorUniversity Hospital Southampton 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
    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.3.4Pharmaceutical 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.3.9.1CAS number 205923564
    D.3.9.2Current sponsor codeRHM CAN0482
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    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 typeIgG1 Monoclonal 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
    Colorectal Cancer
    Liver Metastasis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10052358
    E.1.2Term Colorectal cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary aim of the New EPOC trial is to determine whether the addition of cetuximab to oxaliplatin plus modified de Gramont or irinotecan plus modified de Gramont combination chemotherapy results in improved progression free survival when compared with combination chemotherapy alone in patients who do not possess a KRAS mutant genotype confirmed by laboratory analysis.
    E.2.2Secondary objectives of the trial
    1. To evaluate overall survival
    2. To evaluate quality of life
    3. To compare the experimental arm in terms of cost effectiveness in a UK treatment setting
    4. To determine whether the addition of cetuximab to combination chemotherapy as above results in improved progression free survival when compared with combination chemotherapy alone in patients who possess the KRAS-wt genotype confirmed by laboratory analysis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Confirmed colorectal adenocarcinoma:
     previous or current histologically confirmed primary adenocarcinoma of colon or rectum, together with clinical or radiological evidence of advanced and / or metastatic disease.

    • Presence of potentially resectable colorectal cancer liver metastases without detectable extra-hepatic distant disease. Patients with intra-abdominal loco regional recurrence which in the opinion of the surgeon is easily resectable may be included. The following patients are eligible:

     Patients who have had long course chemoradiation and R0 surgery for rectal cancer
     Patients with rectal cancer who would be suitable for short course radiotherapy as an adjuvant treatment.
     Patients with metachronous metastases having undergone complete resection of the primary tumour without gross or microscopic evidence of residual disease (R0).
     Patients with synchronous metastases who have undergone R0-resection of the primary tumour more than one month before randomisation.
     Patients with synchronous metastases for whom there is sufficient evidence (for example by CT scan or diagnostic laparoscopy) that both the primary tumour and the liver metastases can be completely resected during the same procedure and that resection of primary cancer can be delayed for 3 to 4 months.
     Patients who are thought by the hepatic surgeon to be suboptimally resectable are included. This will normally include patients, for instance, who have potentially resectable disease but in whom compromise of the resection margins is likely. These patients are currently normally treated with pre-operative chemotherapy under NICE guidance. This decision will be at the surgeons discretion.
     Unidimensionally measurable disease (RECIST criteria, see appendix V) to measure pre-operative response.

    • No previous systemic chemotherapy for metastatic disease
     adjuvant chemotherapy with 5FU +/- FA, capecitabine or irinotecan may have been given, if completed > 6 months prior to trial entry.
     rectal chemoradiotherapy with 5FU +/- FA may have been given, if completed > 1 month prior to trial entry.

    • Patients who have received prior oxaliplatin as adjuvant more than six months prior to diagnosis of liver metastases may be offered irinotecan and 5FU instead of oxaliplatin and fluoropyrimidine as neoadjuvant.
    • WHO performance status (PS) 0, 1 or 2 (see appendix VII) and considered by responsible consultant to be fit to undergo combination chemotherapy.
    • Baseline laboratory tests (within 1 week prior to randomisation):
     neutrophils ≥ 1.5 x109/l and platelet count ≥ 100 x109/l
     serum bilirubin ≤ 1.25 x upper limit of normal (ULN), alkaline phosphatase ≤ 5 x ULN, and serum transaminase (either AST or ALT) ≤ 2.5 x ULN
     estimated creatinine clearance (Cockcroft; appendix VIII) >50ml/min or measured GFR (EDTA clearance) >50 ml/min.

    • All patients must be aged 18 years or older.
    • For women of childbearing potential, negative pregnancy test and adequate contraceptive precautions. Adequate contraception for men.
    • Written informed consent.
    • Consent to allow surplus pathological material to be analysed for translational research projects (patients may decline participation in this supplementary component and still participate in the main trial).
    E.4Principal exclusion criteria
    • Patients who are unfit for the chemotherapy regimens in this protocol, e.g.:
     severe uncontrolled concurrent medical illness (including poorly-controlled angina or very recent MI, i.e. in previous 3 months) likely to interfere with protocol treatments.
     Any psychiatric or neurological condition which is felt likely to compromise the patient's ability to give informed consent or to comply with oral medication.
     Partial or complete bowel obstruction.
     Pre-existing neuropathy (> grade 1).

    • Patients requiring ongoing treatment with a contraindicated concomitant medication.
    • Patients with another previous or current malignant disease which, in the judgement of the treating investigator, is likely to interfere with New EPOC treatment or assessment of response.
    • Patients with known hypersensitivity reactions to any of the components of the study treatments.
    • Patients with distant metastases outside the liver.
    • Female patients who are lactating.
    • Patients with a personal or family history suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency or with known DPD deficiency.
    • Patients who possess the KRAS-mt genotype or whose KRAS genotype status is unknown in the primary tumour.
    • Partial or complete bowel obstruction.
    • Chronic diarrhoea or inflammatory bowel disease.
    • Gilbert’s syndrome or other congenital abnormality of biliary transport (e.g. Crigler-Najjar syndrome, Dubin-Johnson syndrome).
    • Previous transplant surgery, requiring immunosuppressive therapy (due to interaction of cyclosporin-A with irinotecan).
    • Patients with ≥ grade 1 residual neurotoxicity following oxaliplatin as adjuvant may be offered irinotecan and 5FU instead of oxaliplatin and fluoropyrimidine as neoadjuvant.
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival.
    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 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.8.3 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 concerned60
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 end of the trial will occur when the final patient has attended their last follow-up visit.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years8
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 288
    F.4.2.2In the whole clinical trial 288
    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 Decision2006-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-12-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-05-22
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