PRIMUS 001: A Study Looking at Two Different Chemotherapy Regimens in Patients With Metastatic Pancreatic Cancer
NCT ID: NCT04151277
Last Updated: 2024-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
500 participants
INTERVENTIONAL
2017-11-28
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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, IV over 2 hours, day 1
* 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 48 hours as per standard practice))
FOLFOX-A
Patients will recieve nab-paclitaxel, oxaliplatin, Folinic Acid and 5-FU in a 14 day cycle
G-CSF
Patients in the FOLFOX-A arm will also receive daily G-CSF as primary prophylaxis for all cycles. This will be given as per local site policy for 14 day chemotherapy regimens
Abraxane and Gemcitabine
* nab-paclitaxel: 125 mg/m2 IV over 30 minutes, day 1, 8, and 15 (administered first)
* Gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 (immediately following nab-paclitaxel)
Gemcitabe and Abraxane
Patients will receive gemcitabine and nab-paclitaxel 3 weeks out of 4
Interventions
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FOLFOX-A
Patients will recieve nab-paclitaxel, oxaliplatin, Folinic Acid and 5-FU in a 14 day cycle
Gemcitabe and Abraxane
Patients will receive gemcitabine and nab-paclitaxel 3 weeks out of 4
G-CSF
Patients in the FOLFOX-A arm will also receive daily G-CSF as primary prophylaxis for all cycles. This will be given as per local site policy for 14 day chemotherapy regimens
Eligibility Criteria
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Inclusion Criteria
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 12 weeks
7. Patients must have received no previous chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatment with a fluoropyrimidine and/or gemcitabine administered in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no ongoing toxicities are present
8. Adequate liver/bone marrow function as defined by:
1. Neutrophils (ANC) ≥ 1.5 x 109/l
2. Platelets ≥ 100 x 109/l
3. Haemoglobin ≥ 9.0 g/dL
4. White Blood Cells (WBC) ≥ 3 x 109/l
5. Total bilirubin ≤ 1.5 x institutional ULN unless bilirubin rise is due to Gilbert's syndrome
6. Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN ( \<5 ULN in the presence of liver metastases)
7. Estimated creatinine clearance ≥ 60 mL/min (as calculated by Cockcroft and Gault or Wright formula or measured by EDTA clearance) 9. Negative serum or urine Human Chorionic Gonadotropin (HCG) test for females with child bearing potential. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential 10. Woman of child bearing potential, and men with female partners of child bearing potential, must agree to use adequate contraceptive measures (see s section 8.1.8.1) for the duration of the study and for up to 6 months after the completion of study treatment. 11. Compliant, and can be followed up regularly
Exclusion Criteria
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 and compliance with protocol
12. Administration of any investigational drug within 28 days or 5 half-lives, whichever is 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 potentially hampering 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/basal cell skin cancer, treated early-stage cervical cancer or treated/biochemically-stable organ-confined prostate cancer)
18. Any patient with severe diarrhoea (defined as ≥grade 3 diarrhoea despite maximum supportive measures and exclusion of underlying infection)
16 Years
ALL
No
Sponsors
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NHS Greater Glasgow and Clyde
OTHER
University of Glasgow
OTHER
Judith Dixon-Hughes
OTHER
Responsible Party
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Judith Dixon-Hughes
Project Manager
Principal Investigators
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Janet Graham
Role: PRINCIPAL_INVESTIGATOR
NHS Greater Glasgow and Clyde
Locations
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Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
Northern Ireland Cancer Centre
Belfast, , United Kingdom
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Royal Bournemouth Hospital
Bournemouth, , United Kingdom
Bristol Oncology Centre
Bristol, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
Castle Hill Hospital
Cottingham, , United Kingdom
Ninewells Hospital
Dundee, , United Kingdom
Western General
Edinburgh, , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Huddersfield Royal Infirmary
Huddersfield, , United Kingdom
Raigmore Hospital
Inverness, , United Kingdom
St James's University Hospital
Leeds, , United Kingdom
The Clatterbridge Cancer Centre
Liverpool, , United Kingdom
Guy's Hospital
London, , United Kingdom
Imperial College Healthcare Trust
London, , United Kingdom
Royal Free London Hospital
London, , United Kingdom
Royal Marsden Hospital
London, , United Kingdom
St Bart's Hospital
London, , United Kingdom
St George's Hospital
London, , United Kingdom
University College London Hospital
London, , United Kingdom
The Christie, Manchester
Manchester, , United Kingdom
Milton Keynes General Hospital
Milton Keynes, , United Kingdom
Freeman Hospital
Newcastle, , United Kingdom
Nottingham University Hospital
Nottingham, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
Poole Hospital
Poole, , United Kingdom
Weston Park
Sheffield, , United Kingdom
University of Southampton Hospital
Southampton, , United Kingdom
Singleton Hospital
Swansea, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Olga Demyanov
Role: primary
Laura McLennan
Role: primary
Christina Armoogum
Role: primary
Other Identifiers
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PRIMUS0012016
Identifier Type: -
Identifier Source: org_study_id
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