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    Summary
    EudraCT Number:2005-005154-44
    Sponsor's Protocol Code Number:OPERA
    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:2005-11-11
    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 number2005-005154-44
    A.3Full title of the trial
    OPERA: OXALIPLATIN AND CETUXIMAB IN FIRST-LINE TREATMENT OF mCRC
    Open, non-controlled, multicenter phase II study evaluating 5-FU/FA plus oxaliplatin (FOLFOX-4) plus cetuximab as first-line treatment for patients with undetectable EGFR-status in metastatic colorectal cancer.
    A.3.2Name or abbreviated title of the trial where available
    OPERA
    A.4.1Sponsor's protocol code numberOPERA
    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 SponsorUniversitätsklinikum Hamburg-Eppendorf
    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 Yes
    D.2.1.1.1Trade name Erbitux
    D.2.1.1.2Name of the Marketing Authorisation holderImCloneSystems Incorporated
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCETUXIMAB
    D.3.9.1CAS number 205923564
    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
    metastasized colorectal cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10052358
    E.1.2Term Colorectal cancer metastatic
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the rate of best confirmed response of 5-FU/FA plus oxaliplatin plus cetuximab as first-line treatment for undetectable epidermal growth factor in metastatic colorectal cancer.
    E.2.2Secondary objectives of the trial
    • Curative metastatic surgery
    • Duration of response
    • Disease control rate
    • Progression-free survival time
    • Overall survival time
    • Safety
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Signed written informed consents
    • Inpatient or outpatient ≥18 years of age
    • Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
    • 1st occurrence of metastatic disease (not curatively resectable)
    • EGFR-negative tumour
    • Life expectancy of at least 12 weeks
    • Presence of at least 1 bi-dimensionally measurable index lesion (not in an irradiated area)
    • ECOG performance status of ≤ 2 at study entry
    • Effective contraception for both male and female subjects if the risk of conception exists
    • White blood cell count (WBC) ≥ 3x10^9/L with neutrophils ≥ 1.5x109/L, platelet count ≥ 100x10^9/L, hemoglobin ≥ 6.21 mmol/L (10 g/dL)
    • ASAT and ALAT ≤ 2.5 x upper reference range, or ≤ 5 x upper reference range in case of liver metastasis
    • Serum creatinine ≤ 1.5 x upper reference range
    • Recovery from relevant toxicity to previous treatment before study entry
    E.4Principal exclusion criteria
    • Previous exposure to epidermal growth factor receptor-targeting therapy
    • Previous oxaliplatin-based chemotherapy
    • Previous chemotherapy for colorectal cancer except adjuvant treatment with progression of disease documented > 6 months after end of adjuvant treatment
    • Radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before inclusion.
    • Concurrent chronic systemic immune therapy or hormone therapy not indicated in this study protocol except physiologic replacement
    • Known hypersensitivity reaction to any of the components of study treatments
    • Pregnancy (absence to be confirmed by ß-hCG test) or lactation period
    • Brain metastasis and/or leptomeningeal disease (known or suspected)
    • Clinically relevant coronary artery disease, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia
    • Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
    • Previous malignancy other than colorectal cancer in the last 5 years except basal cell cancer of the skin or pre-invasive cancer of the cervix
    • Known alcohol or drug abuse
    • Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent
    • Participation in another clinical study within the 30 days before registration.
    • Significant disease which, in the investigator’s opinion, would exclude the subject from the study
    • Peripheral neuropathy > grade 1
    • Legal incapacity or limited legal capacity
    E.5 End points
    E.5.1Primary end point(s)
    The primary target variable related to efficacy is the best overall confirmed tumor response to therapy of either CR or PR .

    Secondary target variables related to efficacy comprise variables based on tumor response and survival time. The following variables describe those, which are directly related to tumor response:

    • The duration of response to assess the time from first assessment of CR or PR until the first date of PD or death
    • Disease control on therapy, i.e. best overall response is either CR, PR, SD, provided the confirmation criteria are met (see section 7.2.3)
    • Progression-free survival time of a patient being defined as the time in months from start of treatment until PD is observed or death occurs due to any cause within 90 days after the last tumor assessment.

    In addition, survival time and curative metastatic surgery will be of further interest.
    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 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) 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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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.8.4.1Number of sites anticipated in Member State concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    The end of trial is defined as the moment all subjects have performed the first 3-monthly Follow-Up visit.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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 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 2005-11-11. Yes
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 70
    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)
    Subjects that stop all treatment (5-FU/FA plus oxaliplatin plus cetuximab) before having reached progression of disease will remain in the study and will continue to be assessed for response every 8 weeks until progression of disease (i.e. “post-treatment phase”).
    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 Decision2006-01-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-03-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-09-19
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