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    Summary
    EudraCT Number:2006-001742-13
    Sponsor's Protocol Code Number:06_RADIO_56
    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:2006-09-29
    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 number2006-001742-13
    A.3Full title of the trial
    Locally Advanced Pancreatic Cancer: Phase II study of cetuximab and 3-D conformal image-guided radiotherapy (PACER Study)
    A.3.2Name or abbreviated title of the trial where available
    PACER Study
    A.4.1Sponsor's protocol code number06_RADIO_56
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 SponsorChristie Hospital NHS 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.3.1Product nameCetuximab
    D.3.2Product code Erbitux
    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 typeCetuximab is a chimeric monoclonal IgG1 antibody produced in a mammalian cell line (Sp2/0) by recombinant DNA technology
    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 pancreas which is locally advanced/inoperable
    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 evaluate the progression free survival rate in patients treated with cetuximab and radiotherapy.
    E.2.2Secondary objectives of the trial
    To determine the response rate, toxicity of the combined regimen, and clinical benefit response in patients treated with cetuximab and radiotherapy.

    To assess the value of FDG-PET as a pharmacodynamic marker of tumour response.

    To evaluate the value of FDG-PET as a prognostic marker.

    To establish the best time to measure serum protein changes following treatment with concurrent cetuximab and radiation.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Functional imaging translational (FIT) study in patients taking part in the PACER trial (PACER-FIT). Version 1. Date 10.07.06

    AIMS:
    (i) To assess the value of FDG-PET as a pharmacodynamic marker of tumour response
    (ii) To assess the value of FDG-PET as a prognostic marker
    (iii) To evaluate changes in tumour perfusion with cetuximab/radiotherapy

    Translational Molecular Biology Study in patients with Locally Advanced Pancreatic Cancer being treated with Concurrent Cetuximab and Image Guided External Beam Radiotherapy (PACER-TRANS). Version 1. Date 10.07.06

    AIMS:
    (i)The aim of the study is to study the mechanism of interaction between cetuximab & radiotherapy and to identify novel bio-markers that could be validated in a larger phase III trial.
    E.3Principal inclusion criteria
    •Histopathological or cytological diagnosis of inoperable, non-metastatic pancreatic adenocarcinoma
    •Karnofsky Performance (KP) Status 100 - 60
    •Age ≥ 18 and estimated life expectancy > 3 months
    •Adequate haematological function: Haemoglobin ≥ 10g/dl; WBC ≥ 3.0 x 109/l; ANC ≥ 1.5 x 109/l; platelet count ≥ 100,000/mm3 (prior transfusions for patients with low haemoglobin allowed)
    •Adequate liver function: total bilirubin ≤ 1.5 x ULN; ALT & AST ≤ 1.5 x ULN; ALP ≤ 4 x ULN
    •Adequate renal function with serum urea & creatinine ≤ 1.5 x ULN and a calculated creatinine clearance (Appendix 2) of > 50 ml/min. If the calculated creatinine clearance is marginally less than > 50 ml/min, an isotopic EDTA clearance test will be performed to confirm the creatinine clearance.
    •Adequate biliary drainage with no evidence of active uncontrolled infection (patients on prophylactic antibiotics are eligible)
    •Women of child-bearing potential should have a negative pregnancy test prior to study entry AND be suing an adequate contraception method, which must be continued for 3 months after completion of chemotherapy
    •Capable of giving informed consent
    •Following types of interventions are allowed:
    - non-curative operation (i.e. R2 resection with macroscopic residual disease evident on CT scan or palliative bypass procedure)
    - stent insertion in the common bile duct
    •KP Status 60–100
    •Patients able to tolerate 3 PET scans
    E.4Principal exclusion criteria
    •Patients with neuroendocrine tumours or lymphoma of the pancreas
    •Incomplete recovery from previous surgery or unresolved biliary tract obstruction
    •Patients with metastatic disease
    •Patients with extensive disease unable to be covered in a radically treatable radiotherapy volume
    •Previous radiotherapy within treatment field
    •Relative contraindication to radiotherapy
    •Previous administration of EGF monoclonal antibodies, EGFR signal transduction inhibitors or EGFR targeted therapy
    •History of prior malignancy that will interfere with the response evaluation (except cervical carcinoma in-situ treated by cone-biopsy/resection, non-metastatic basal &/or squamous cell carcinomas of the skin, any early stage (stage I) malignancy adequately resected for cure greater than 5 years previously)
    •Any evidence of severe uncontrolled systemic diseases or laboratory finding that in the view of investigator makes it undesirable for the patient to participate in the trial
    •Any disorder likely to impact compliance with the protocol
    •Pregnancy or breast feeding
    •Patients unable to give informed consent
    •Patients with other serious co-morbid conditions and/or serious uncontrolled infections
    •Sexually active males or females of reproductive capacity who are not employing adequate contraception
    •Patients whose sociological, psychological, familial and geographical conditions do not permit compliance with the protocol
    •Patients with a haemoglobin level < 10 g / dl
    •Patients must not have any bleeding disorder nor be on anticoagulants
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the progression free survival rate in patients treated with cetuximab and radiotherapy.
    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 Yes
    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) 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 concerned2
    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 treatment phase of the study will conclude when the last patient enrolled in the study has received the last protocol-directed treatment. The observational phase will conclude when the last patient has been followed up for survival 3 years after concluding the treatment phase.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    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 state44
    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)
    Upon completion of treatment in the protocol, every patient will continue follow-up under their treating oncologist. Treatment upon disease relapse will conform to local institutional guidelines in consultation with the patient.
    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 Decision2006-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-10-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2010-09-15
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