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Be Part of Research - Trial Details - PRIMUS001: A study looking at two different treatments for pancreatic cancer that has spread to other parts of the body

PRIMUS001: A study looking at two different treatments for pancreatic cancer that has spread to other parts of the body

Medical Conditions

Metastatic pancreatic cancer


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Sep 2017 31 Dec 2024

Interventional

Intervention Type : Drug
Intervention Description : Patients will call the CTU to randomise the patients and they will be randomised on a 1:1 basis with 50% receiving AG and 50% FOLFOX-A. Minimisation will be used to allocate patients between the treatment arms, the following factors will be used: treatment centre, whether or not the patient has liver metastasis, whether the primary tumour is in the head or the tail of the pancreas and the patients baseline CA19.9.

FOLFOX-A (nab-paclitaxel 150mg/m2 IV over 30 minutes, day 1 (administered first), Oxaliplatin: 85mg/m2, IV over 2 hours, day 1, Folinic acid: 350 mg flat dose or 400mg/m2, IV over 2 hours, day 1 (as per standard of care for folinic acid dosing), 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.)

OR

AG (nab-paclitaxel: 125 mg/m2 IV over 30 minutes, day 1,8, and 15 (administered first and Gemcitabine 1000 mg/m2 IV over 30 mins on days 1, 8, and 15 (immediately following nab-paclitaxel).

When the patient progressed on CT scan treatment will stop and the end of treatment visit will take place with 28 days of the last treatment. At this visit any con meds will be reviewed, physical exam (weight, BP, pulse), ECOG, blood count and biochemistry, assessment of adverse events, CA19.9 and quality of life.

After that patients will be followed up every 3 months for the first year post randomisation, 18 months after randomisation, 24 months and then annually for up to 5 years. At these visits con meds, including any new cancer treatments will be recorded, ECOG, CA19.9, quality of life assessments and survival status will be recorded.




You can take part if:



You may not be able to take part if:


Current exclusion criteria as of 12/03/2024:

1. Prior treatment with nab-paclitaxel or oxaliplatin2. Prior chemotherapy for metastatic pancreatic cancer3. Known hypersensitivity for any component of any study drug4. Active infection including Herpes Zoster and chickenpox5. Current neuropathy ≥ grade 26. Uncontrolled brain metastatsis or mental illness7. Uncontrolled congestive heart failure (CHF), or history of myocardial ischemia (MI), unstable angina, stroke, or transient ischemia within previous 6 months.8. Uncontrolled serious contraindicated medical condition or illness9. Known or suspected dihydropyrimidine (DPD) deficiency10. Pregnant of breastfeeding11. History of physical or psychiatric disorder that would prevent informed consent and compliance with protocol12. Administration of any investigational drug within 28 days or 5 half-lives, whichever is longer, of receiving the first dose of trial treatment13. Any systemic anti-cancer therapy, or major surgery within 28 days of randomisation14. Any minor surgery or radiotherapy within 7 days of randomisation15. Any psychological, familial, sociological or geographical consideration potentially hampering compliance with the trial protocol and follow up schedule.16. Any patients receiving treatment with brivudin, sorivudin and analogues17. History of another malignancy in the last 3 years (other than treated squamous/basal cell skin cancer, treated early-stage cervical cancer or treated/biochemically-stable, organ-confined prostate cancer)19. Any patient with severe diarrhoea (defined as ≥grade 3 diarrhoea despite maximum supportive measures and exclusion of underlying infection

_____

Previous exclusion criteria:

1. Prior treatment with nab-paclitaxel or oxaliplatin2. Prior chemotherapy for metastatic pancreatic cancer3. Known hypersensitivity for any component of any study drug4. Active infection including Herpes Zoster and chickenpox5. Current neuropathy ≥ grade 26. Uncontrolled brain metastatsis or mental illness7. Uncontrolled congestive heart failure (CHF), or history of myocardial ischemia (MI), unstable angina, stroke, or transient ischemia within previous 6 months.8. Uncontrolled serious contraindicated medical condition or illness9. Known or suspected dihydropyrimidine (DPD) deficiency10. Pregnant of breastfeeding11. History of physical or psychiatric disorder that would prevent informed consent and compliance with protocol12. Administration of any investigational drug within 28 days or 5 half-lives, whichever is longer, of receiving the first dose of trial treatment13. Any systemic anti-cancer therapy, or major surgery within 28 days of randomisation14. Any minor surgery or radiotherapy within 7 days of randomisation15. Any psychological, familial, sociological or geographical consideration potentially hampering compliance with the trial protocol and follow up schedule.16. Any patients receiving treatment with brivudin, sorivudin and analogues17. History of another malignancy in the last 5 years (other than treated squamous/basal cell skin cancer, treated early-stage cervical cancer or treated/bio18. Chemically-stable, organ-confined prostate cancer)19. Any patient with severe diarrhoea (defined as ≥grade 3 diarrhoea despite maximum supportive measures and exclusion of underlying infection


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • University Hospitals Coventry and Warwickshire NHS Trust
    Walsgrave General Hospital Clifford Bridge Road
    Coventry
    CV2 2DX
  • Royal Marsden Hospital
    Downs Road
    Sutton
    SM2 5PT
  • Royal Free Hospital
    Pond Street
    London
    NW3 2QG
  • Nottingham University Hospitals NHS Trust - Queen's Medical Centre Campus
    Nottingham University Hospital Derby Road
    Nottingham
    NG7 2UH
  • Raigmore Hospital
    Old Perth Rd
    Inverness
    IV2 3UJ
  • Churchill Hospital
    Old Road Headington
    Oxford
    OX3 7LE
  • Velindre Cancer Centre
    Velindre Road
    Cardiff
    CF14 2TL
  • St George's Hospital
    Blackshaw Road
    London
    SW17 0QT
  • Western General Hospital
    Crewe Road South Edinburgh
    Lothian
    EH4 2XU
  • Addenbrooke's Hospital
    Hills Road
    Cambridge
    CB2 0QQ
  • Castle Hill Hospital
    Castle Road
    Cottingham
    HU16 5JQ
  • Guy's Hospital
    Great Maze Pond
    London
    SE1 9RT
  • Singleton Hospital
    Sketty Lane Sketty
    Swansea
    SA2 8QA
  • Bristol Haematology and Oncology Centre
    Horfield Road
    Bristol
    BS2 8ED
  • Ninewells Hospital and Medical School
    Dundee
    DD1 9SY
  • Queen Elizabeth Hospital
    Mindelsohn Way Edgbaston
    Birmingham
    B15 2TH
  • University Hospital Southampton
    Tremona Road
    Southampton
    SO16 6YD
  • Milton Keynes General Hospital
    Milton Keynes Hospital Standing Way Eaglestone
    Milton Keynes
    MK6 5LD
  • St James's University Hospital NHS Trust
    St James's University Hospital Gledow Wing Beckett Street
    Leeds
    LS9 7TF
  • The Royal Marsden Hospital
    Fulham Road
    London
    SW3 6JJ
  • Norfolk and Norwich Hospital
    Colney Lane Colney
    Norwich
    NR4 7UY
  • Beatson West of Scotland Cancer Centre
    1053 Great Western Road
    Glasgow
    G20 9JG
  • The Christie NHS Foundation Trust
    550 Wilmslow Road
    Manchester
    M20 4BX
  • Northern Ireland Cancer Centre
    Belfast City Hospital 10 Jubilee Road
    Belfast
    BT9 7AB
  • University College Hospital
    235 Euston Road Bloomsbury
    London
    NW1 2PG
  • Clatterbridge Cancer Centre - Aintree
    Aintree Clatterbridge Cancer Centre Lower Lane Fazakerley
    Liverpool
    L9 7AL
  • Huddersfield Royal Infirmary
    25 Acre Street Lindley
    Huddersfield
    HD3 3EA
  • University Hospitals Dorset NHS Foundation Trust
    Longfleet Road
    Poole
    BH15 2JB
  • Royal Cornwall Hospitals & West Cornwall Hospital
    Royal Cornwall Hospitals NHS Trust Treliske Hospital Treliske
    Truro
    TR1 3LJ
  • St Bartholomews Hospital
    New Road
    Rochester
    ME1 1DS
  • Weston Park Hospital Cancer Centre
    Whitham Road Broomhall
    Sheffield
    S10 2SJ

This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.


The study is sponsored by NHS Greater Glasgow and Clyde and funded by Cancer Research UK; Celgene.




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Read full details for Trial ID: ISRCTN75002153
Last updated 08 April 2024

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