PRIMUS 001: A Study Looking at Two Different Chemotherapy Regimens in Patients With Metastatic Pancreatic Cancer

Last updated: February 7, 2024
Sponsor: Judith Dixon-Hughes
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Gemcitabe and Abraxane

G-CSF

FOLFOX-A

Clinical Study ID

NCT04151277
PRIMUS0012016
  • Ages > 16
  • All Genders

Study Summary

This study is comparing two combinations of chemotherapy treatments in patients with metastatic pancreatic cancer. Half the participants will receive FOLFOX-A and the other half will receive AG. Treatment will continue until progression or patient/clinican decision or intolerable toxicity.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient has been enrolled in the Precision-Panc Master Protocol
  2. Patient has provided signed information consent for the PRIMUS 001 study
  3. Age ≥ 16 years
  4. Histologically-confirmed pancreatic ductal adenocarcinoma and its varients
  5. Measurable metastatic disease according to RECIST V1.1
  6. Eastern Cooperative Oncology Group (ECOG) 0-1 with life expectation of no less than 12weeks
  7. Patients must have received no previous chemotherapy or investigational therapy forthe treatment of metastatic disease. Prior treatment with a fluoropyrimidine and/orgemcitabine administered in the adjuvant setting is allowed, provided at least 6months have elapsed since completion of the last dose and no ongoing toxicities arepresent
  8. Adequate liver/bone marrow function as defined by:
  9. Neutrophils (ANC) ≥ 1.5 x 109/l
  10. Platelets ≥ 100 x 109/l
  11. Haemoglobin ≥ 9.0 g/dL
  12. White Blood Cells (WBC) ≥ 3 x 109/l
  13. Total bilirubin ≤ 1.5 x institutional ULN unless bilirubin rise is due toGilbert's syndrome
  14. Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN ( <5ULN in the presence of liver metastases)
  15. Estimated creatinine clearance ≥ 60 mL/min (as calculated by Cockcroft and Gaultor Wright formula or measured by EDTA clearance) 9. Negative serum or urine HumanChorionic Gonadotropin (HCG) test for females with child bearing potential.Postmenopausal women must have been amenorrhoeic for at least 12 months to beconsidered of non-childbearing potential 10. Woman of child bearing potential,and men with female partners of child bearing potential, must agree to useadequate contraceptive measures (see s section 8.1.8.1) for the duration of thestudy and for up to 6 months after the completion of study treatment. 11.Compliant, and can be followed up regularly The following additional inclusion criteria is ONLY required if recommended by theindependent Data Monitoring Committee after interim review of study data (sites will havebeen informed by the Cancer Research UK (CRUK) Clinical Trials Unit (CTU) if this is thecase) 12. Patient must be biomarker positive as fed back after central Precision-Pancdiagnostic testing

Exclusion

Exclusion Criteria:

  1. Prior treatment with nab-paclitaxel or oxaliplatin
  2. Prior chemotherapy for metastatic pancreatic cancer
  3. Known hypersensitivity for any component of any study drug
  4. Active infection including Herpes Zoster and chickenpox
  5. Current neuropathy ≥ grade 2
  6. Uncontrolled brain metastasis
  7. 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 illness
  9. Known or suspected dihydropyrimidine dehydrogenase (DPD) deficiency
  10. Pregnant or breastfeeding
  11. History of physical or psychiatric disorder that would prevent informed consent andcompliance with protocol
  12. Administration of any investigational drug within 28 days or 5 half-lives, whicheveris longer, of receiving the first dose of trial treatment
  13. Any systemic anti-cancer therapy or major surgery within 28 days of randomisation
  14. Any minor surgery or radiotherapy within 7 days of randomisation
  15. Any psychological, familial, sociological or geographical consideration potentiallyhampering compliance with the trial protocol and follow up schedule
  16. Any patients receiving treatment with brivudin, sorivudin and analogues
  17. History of another malignancy in the last 5 years (other than treated squamous/basalcell skin cancer, treated early-stage cervical cancer or treated/biochemically-stableorgan-confined prostate cancer)
  18. Any patient with severe diarrhoea (defined as ≥grade 3 diarrhoea despite maximumsupportive measures and exclusion of underlying infection)

Study Design

Total Participants: 500
Treatment Group(s): 3
Primary Treatment: Gemcitabe and Abraxane
Phase: 2
Study Start date:
November 28, 2017
Estimated Completion Date:
January 31, 2026

Study Description

PRIMUS 001 is a multicentre, randomised, open label, two arm, phase II interventional trial with pre-clinical and translational work including in-depth molecular profiling and biomarker discovery/development. The primary objective is to look at the efficacy of FOLFOX-A compared to AG in all comers and in a biomarker positive group using progression free survival.

Connect with a study center

  • Aberdeen Royal Infirmary

    Aberdeen,
    United Kingdom

    Active - Recruiting

  • Northern Ireland Cancer Centre

    Belfast,
    United Kingdom

    Active - Recruiting

  • Queen Elizabeth Hospital

    Birmingham,
    United Kingdom

    Active - Recruiting

  • Royal Bournemouth Hospital

    Bournemouth,
    United Kingdom

    Active - Recruiting

  • Bristol Oncology Centre

    Bristol,
    United Kingdom

    Active - Recruiting

  • Addenbrooke's Hospital

    Cambridge,
    United Kingdom

    Active - Recruiting

  • Castle Hill Hospital

    Cottingham,
    United Kingdom

    Active - Recruiting

  • Ninewells Hospital

    Dundee,
    United Kingdom

    Active - Recruiting

  • Western General

    Edinburgh,
    United Kingdom

    Active - Recruiting

  • Beatson West of Scotland Cancer Centre

    Glasgow,
    United Kingdom

    Active - Recruiting

  • Huddersfield Royal Infirmary

    Huddersfield, HD3 3EA
    United Kingdom

    Active - Recruiting

  • Raigmore Hospital

    Inverness,
    United Kingdom

    Active - Recruiting

  • St James's University Hospital

    Leeds,
    United Kingdom

    Active - Recruiting

  • The Clatterbridge Cancer Centre

    Liverpool, CH63 4JY
    United Kingdom

    Active - Recruiting

  • Guy's Hospital

    London,
    United Kingdom

    Active - Recruiting

  • Imperial College Healthcare Trust

    London,
    United Kingdom

    Active - Recruiting

  • Royal Free London Hospital

    London,
    United Kingdom

    Active - Recruiting

  • Royal Marsden Hospital

    London,
    United Kingdom

    Active - Recruiting

  • St Bart's Hospital

    London,
    United Kingdom

    Active - Recruiting

  • St George's Hospital

    London,
    United Kingdom

    Active - Recruiting

  • University College London Hospital

    London,
    United Kingdom

    Active - Recruiting

  • The Christie, Manchester

    Manchester,
    United Kingdom

    Active - Recruiting

  • Milton Keynes General Hospital

    Milton Keynes,
    United Kingdom

    Active - Recruiting

  • Freeman Hospital

    Newcastle,
    United Kingdom

    Active - Recruiting

  • Nottingham University Hospital

    Nottingham,
    United Kingdom

    Active - Recruiting

  • Churchill Hospital

    Oxford,
    United Kingdom

    Active - Recruiting

  • Poole Hospital

    Poole,
    United Kingdom

    Active - Recruiting

  • Weston Park

    Sheffield,
    United Kingdom

    Active - Recruiting

  • University of Southampton Hospital

    Southampton,
    United Kingdom

    Active - Recruiting

  • Singleton Hospital

    Swansea,
    United Kingdom

    Active - Recruiting

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