PRIMUS 001: A Study Looking at Two Different Chemotherapy Regimens in Patients With Metastatic Pancreatic Cancer
PRIMUS 001: An Adaptive Phase II Study of FOLFOX-A (FOLFOX and Nab-paclitaxel) Versus AG (Nab-paclitaxel and Gemcitabine) in Patients With Metastatic Pancreatic Cancer, With Integrated Biomarker Evaluation
1 other identifier
interventional
500
1 country
30
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2017
Longer than P75 for phase_2
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 28, 2017
CompletedFirst Submitted
Initial submission to the registry
October 25, 2019
CompletedFirst Posted
Study publicly available on registry
November 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2026
CompletedFebruary 8, 2024
February 1, 2024
8.1 years
October 25, 2019
February 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
Progression free survival as measured froim the date of randomisation to progression or death (from any cause)
At time of progression (estimated to be between 5 and 7.5 months)
Secondary Outcomes (10)
Ojective Response Rate
Measured every 8 weeks by CT scan (most patients will received 3-4 CT scans over 24-32 weeks))
Overall Survival
From date of randomisation until date of death from any cause. Most patients with metastatic pancreatic cancer will die within 6-9 months from diagnosis
Safety and Tolerability of FOLFOX-A treatment
At every chemotherapy visit (every 2 weeks) - and at end of treatment visit (within 30 days of completing chemotherapy). Chemotherapy will continue until progression (estimated at between 5-7.5 months)
Safety and Tolerability of AG treatment
At every chemotherapy visit (3 weeks out of every 4) - and at end of treatment visit (within 30 days of completing chemotherapy). Chemotherapy will continue until progression (estimated at between 5-7.5 months)
Quality of Life (EORTC QLQ-C30)
Every 8 weeks while on treatment, at end of treatment visit, which will take place within 30 days of completing treatment, and at follow-up visits (6, 9, 12, 18, 24, 36, 48 and 60 months post randomisation).
- +5 more secondary outcomes
Study Arms (2)
FOLFOX-A
EXPERIMENTAL* 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))
Abraxane and Gemcitabine
ACTIVE COMPARATOR* 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)
Interventions
Patients will recieve nab-paclitaxel, oxaliplatin, Folinic Acid and 5-FU in a 14 day cycle
Patients will receive gemcitabine and nab-paclitaxel 3 weeks out of 4
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
You may qualify if:
- Patient has been enrolled in the Precision-Panc Master Protocol
- Patient has provided signed information consent for the PRIMUS 001 study
- Age ≥ 16 years
- Histologically-confirmed pancreatic ductal adenocarcinoma and its varients
- Measurable metastatic disease according to RECIST V1.1
- Eastern Cooperative Oncology Group (ECOG) 0-1 with life expectation of no less than 12 weeks
- 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
- Adequate liver/bone marrow function as defined by:
- Neutrophils (ANC) ≥ 1.5 x 109/l
- Platelets ≥ 100 x 109/l
- Haemoglobin ≥ 9.0 g/dL
- White Blood Cells (WBC) ≥ 3 x 109/l
- Total bilirubin ≤ 1.5 x institutional ULN unless bilirubin rise is due to Gilbert's syndrome
- Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN ( \<5 ULN in the presence of liver metastases)
- 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
You may not qualify if:
- Prior treatment with nab-paclitaxel or oxaliplatin
- Prior chemotherapy for metastatic pancreatic cancer
- Known hypersensitivity for any component of any study drug
- Active infection including Herpes Zoster and chickenpox
- Current neuropathy ≥ grade 2
- Uncontrolled brain metastasis
- Uncontrolled congestive heart failure (CHF), or history of myocardial ischemia (MI), unstable angina, stroke, or transient ischemia within previous 6 months
- Uncontrolled serious contraindicated medical condition or illness
- Known or suspected dihydropyrimidine dehydrogenase (DPD) deficiency
- Pregnant or breastfeeding
- History of physical or psychiatric disorder that would prevent informed consent and compliance with protocol
- Administration of any investigational drug within 28 days or 5 half-lives, whichever is longer, of receiving the first dose of trial treatment
- Any systemic anti-cancer therapy or major surgery within 28 days of randomisation
- Any minor surgery or radiotherapy within 7 days of randomisation
- Any psychological, familial, sociological or geographical consideration potentially hampering compliance with the trial protocol and follow up schedule
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Judith Dixon-Hugheslead
- NHS Greater Glasgow and Clydecollaborator
- University of Glasgowcollaborator
Study Sites (30)
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, HD3 3EA, United Kingdom
Raigmore Hospital
Inverness, United Kingdom
St James's University Hospital
Leeds, United Kingdom
The Clatterbridge Cancer Centre
Liverpool, CH63 4JY, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Janet Graham
NHS Greater Glasgow and Clyde
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Project Manager
Study Record Dates
First Submitted
October 25, 2019
First Posted
November 5, 2019
Study Start
November 28, 2017
Primary Completion
December 31, 2025
Study Completion
January 31, 2026
Last Updated
February 8, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- After publication of study
- Access Criteria
- On Request to Trial Management Group
At the end of the study, once the study report has been written and published, the anonymised clinical data will be available via request to Trial Management Group