PRIMUS001: A study looking at two different treatments for pancreatic cancer that has spread to other parts of the body
| ISRCTN | ISRCTN75002153 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75002153 |
| EudraCT/CTIS number | 2016-004155-67 |
| IRAS number | 221370 |
| ClinicalTrials.gov number | NCT04151277 |
| Secondary identifying numbers | PRIMUS0012016, IRAS 221370 |
- Submission date
- 30/05/2017
- Registration date
- 31/05/2017
- Last edited
- 08/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Contact information
Ms Sarah Bradley
Scientific
Scientific
University of Glasgow Clinical Trials Unit, Level 0
Beatson West of Scotland Cancer Centre
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom
| Phone | +44 (0)141 301 7540 |
|---|---|
| Sarah.Bradley@glasgow.ac.uk |
Ms Sarah Bradley
Public
Public
University of Glasgow Clinical Trials Unit, Level 0
Beatson West of Scotland Cancer Centre
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom
| Phone | +44 (0)141 301 7540 |
|---|---|
| sarah.bradley@glasgow.ac.uk |
Study information
| Study design | Multi-centre randomised open label two arm phase II trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | 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 |
| Study acronym | PRIMUS 001 |
| Study objectives | That FOLFOX-A will increase progression free survival in metastatic pancreatic cancer patients over AG |
| Ethics approval(s) |
Approved 03/08/2017, West of Scotland REC (Dykebar Hospital, Glasgow, PA2 7DE, United Kingdom; +44 141 314 0211; Ruth.Hood2@ggc.scot.nhs.uk), ref: 17/WS/0142 |
| Health condition(s) or problem(s) studied | Metastatic pancreatic cancer |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Nab-paclitaxel, gemcitabine, oxaliplatin, folinic acid, 5-fluorouracil |
| Primary outcome measure | Progression free survival as measured by IV contrast enhanced CT scan every 8 weeks from the date of randomisation to progression or death (from any cause), whichever occurs first. |
| Secondary outcome measures | 1. Objective response rate based on RECIST v1.1 will be measured by contrast enchanged CT scan every 8 weeks until disease progression 2. Overall survival will be recorded at each study visit up to 60 months post randomisation 3. Safety and tolerability will be assessed using NCI-CTCAE v4. Adverse events will be collected at each treatment visit and the end of treatment visit. 4. Quality of life will be assessed using EORTC QLQ-C30, QLQ PAN26, ED-5D-5L monthly while on treatment and then at each follow up visit 5. Peripheral neuropathy will be assessed by the GOG-NTX4 questionnaire monthly while on treatment and then at each follow up visit 6. Health Economics: Resource use will be assessed by the EQ-5d-5L monthly while on treatment and then at each follow up visit. Information will also be collected regarding any inpatients stays in hospital during the course of the study |
| Overall study start date | 01/04/2017 |
| Completion date | 31/07/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 460 |
| Key inclusion criteria | 1. Patient has been enrolled in the Precision Panc Master Protocol and their tissue has been deemed suitable for NGS analysis 2. Patient has provided signed information consent for the PRIMUS 001 study 3. Age 16 years and over 4. Histologically-confirmed metastatic pancreatic ductal adenocarcinoma and its varients, with measurable metastatic lesion(s) according to RECIST 1.1. 5. Eastern Cooperative Oncology Group (ECOG) 0-1 with life expectation of no less than 12 weeks. 6. 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. 7. Adequate liver/bone marrow function as defined by: 7.1. Neutrophils (ANC) ≥ 1.5 x 109/l 7.2. Platelets ≥ 100 x 109/l 7.3. Haemoglobin ≥ 9.0 g/dL 7.4. WBC ≥ 3 x 109/l 7.5. Total bilirubin ≤ 1.5 x institutional ULN unless bilirubin rise is due to Gilbert’s syndrome 7.6. Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN (and <5 ULN in the presence of liver metastases) 7.7. Estimated creatinine clearance ≥ 60 mL/min (as calculated by Cockcroft and Gault or Wright formula or measured by EDTA clearance) 8. Negative serum 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 9. Woman of child bearing potential, and men with female partners of child bearing potential, must agree to use adequate contraceptive measures (see section 8.1.8.1) for the duration of the study and for up to 6 months after the completion of study treatment. 10. Compliant, and can be followed up regularly The following additional inclusion criteria is ONLY required if recommended by the independent Data Monitoring Committee after interim review of study data (sites will have been informed by the CRUK CTU if this is the case): 11. Patient must be biomarker positive as fed back after central Precision-PANC diagnostic testing |
| Key exclusion criteria | Current exclusion criteria as of 12/03/2024: 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 metastatsis or mental illness 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 (DPD) deficiency 10. Pregnant of 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 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 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 metastatsis or mental illness 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 (DPD) deficiency 10. Pregnant of 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/bio 18. 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 |
| Date of first enrolment | 01/09/2017 |
| Date of final enrolment | 31/12/2024 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
Beatson West of Scotland Cancer Centre
1053 Great Western Road
Glasgow
G20 9JG
United Kingdom
Glasgow
G20 9JG
United Kingdom
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Cambridge
CB2 0QQ
United Kingdom
Bristol Haematology and Oncology Centre
Horfield Road
Bristol
BS2 8ED
United Kingdom
Bristol
BS2 8ED
United Kingdom
The Christie NHS Foundation Trust
550 Wilmslow Road
Manchester
M20 4BX
United Kingdom
Manchester
M20 4BX
United Kingdom
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
London
SE1 9RT
United Kingdom
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
DD1 9SY
United Kingdom
Northern Ireland Cancer Centre
Belfast City Hospital
10 Jubilee Road
Belfast
BT9 7AB
United Kingdom
10 Jubilee Road
Belfast
BT9 7AB
United Kingdom
Royal Marsden Hospital
Downs Road
Sutton
SM2 5PT
United Kingdom
Sutton
SM2 5PT
United Kingdom
St George's Hospital
Blackshaw Road
London
SW17 0QT
United Kingdom
London
SW17 0QT
United Kingdom
University College Hospital
235 Euston Road
Bloomsbury
London
NW1 2PG
United Kingdom
Bloomsbury
London
NW1 2PG
United Kingdom
University Hospital Southampton
Tremona Road
Southampton
So16 6YD
United Kingdom
Southampton
So16 6YD
United Kingdom
Castle Hill Hospital
Castle Road
Cottingham
HU16 5JQ
United Kingdom
Cottingham
HU16 5JQ
United Kingdom
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LE
United Kingdom
Headington
Oxford
OX3 7LE
United Kingdom
Clatterbridge Cancer Centre - Aintree
Aintree Clatterbridge Cancer Centre
Lower Lane
Fazakerley
Liverpool
L9 7AL
United Kingdom
Lower Lane
Fazakerley
Liverpool
L9 7AL
United Kingdom
Huddersfield Royal Infirmary
25 Acre Street
Lindley
Huddersfield
HD3 3EA
United Kingdom
Lindley
Huddersfield
HD3 3EA
United Kingdom
Milton Keynes General Hospital
Milton Keynes Hospital
Standing Way
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
Standing Way
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
Norfolk and Norwich Hospital
Colney Lane
Colney
Norwich
NR4 7UY
United Kingdom
Colney
Norwich
NR4 7UY
United Kingdom
Nottingham University Hospitals NHS Trust - Queen's Medical Centre Campus
Nottingham University Hospital
Derby Road
Nottingham
NG7 2UH
United Kingdom
Derby Road
Nottingham
NG7 2UH
United Kingdom
University Hospitals Dorset NHS Foundation Trust
Longfleet Road
Poole
BH15 2JB
United Kingdom
Poole
BH15 2JB
United Kingdom
Queen Elizabeth Hospital
Mindelsohn Way
Edgbaston
Birmingham
B15 2TH
United Kingdom
Edgbaston
Birmingham
B15 2TH
United Kingdom
Raigmore Hospital
Old Perth Rd
Inverness
IV2 3UJ
United Kingdom
Inverness
IV2 3UJ
United Kingdom
Royal Cornwall Hospitals & West Cornwall Hospital
Royal Cornwall Hospitals NHS Trust
Treliske Hospital
Treliske
Truro
TR1 3LJ
United Kingdom
Treliske Hospital
Treliske
Truro
TR1 3LJ
United Kingdom
Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom
London
NW3 2QG
United Kingdom
The Royal Marsden Hospital
Fulham Road
London
SW3 6JJ
United Kingdom
London
SW3 6JJ
United Kingdom
Singleton Hospital
Sketty Lane
Sketty
Swansea
SA2 8QA
United Kingdom
Sketty
Swansea
SA2 8QA
United Kingdom
St Bartholomews Hospital
New Road
Rochester
ME1 1DS
United Kingdom
Rochester
ME1 1DS
United Kingdom
St James's University Hospital NHS Trust
St James's University Hospital
Gledow Wing
Beckett Street
Leeds
LS9 7TF
United Kingdom
Gledow Wing
Beckett Street
Leeds
LS9 7TF
United Kingdom
Velindre Cancer Centre
Velindre Road
Cardiff
CF14 2TL
United Kingdom
Cardiff
CF14 2TL
United Kingdom
Western General Hospital
Crewe Road South
Edinburgh
Lothian
EH4 2XU
United Kingdom
Edinburgh
Lothian
EH4 2XU
United Kingdom
Weston Park Hospital Cancer Centre
Whitham Road
Broomhall
Sheffield
S10 2SJ
United Kingdom
Broomhall
Sheffield
S10 2SJ
United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust
Walsgrave General Hospital
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Sponsor information
NHS Greater Glasgow and Clyde
Hospital/treatment centre
Hospital/treatment centre
West Glasgow Ambulatory Care Hospital
Dalnair Street
Glasgow
G3 8SJ
Scotland
United Kingdom
| Phone | +44 1412 321818 |
|---|---|
| Joanne.McGarry@ggc.scot.nhs.uk | |
"ROR" |
https://ror.org/05kdz4d87 |
Funders
Funder type
Charity
Cancer Research UK
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Celgene
Private sector organisation / For-profit companies (industry)
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Celgene Corporation
- Location
- United States of America
Results and Publications
| Intention to publish date | 31/01/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request. Caroline.Kelly@glasgow.ac.uk |
Editorial Notes
08/04/2024: ClinicalTrials.gov number added.
12/03/2024: The following changes were made to the trial record:
1. The ethics approval was added.
2. The exclusion criteria were changed.
3. The study participating centres Imperial College Healthcare NHS Trust, Walsgrave General Hospital, Freeman Hospital, Royal Bournemouth Hospital Bcsc were removed and University Hospitals Coventry and Warwickshire NHS Trust was added.
06/11/2023: The following changes were made:
1. IRAS number added.
2. Drug/device/biological/vaccine names added.
3. The target number of participants was changed from 500 to 460.
4. Castle Hill Hospital, Churchill Hospital, Clatterbridge Cancer Centre - Aintree, Walsgrave General Hospital, Freeman Hospital, Huddersfield Royal Infirmary, Milton Keynes General Hospital, Norfolk and Norwich Hospital, Nottingham University Hospitals NHS Trust - Queen's Medical Centre Campus, University Hospitals Dorset NHS Foundation Trust, Queen Elizabeth Hospital, Raigmore Hospital, Royal Bournemouth Hospital Bcsc, Royal Cornwall Hospitals & West Cornwall Hospital, Royal Free Hospital, The Royal Marsden Hospital, Singleton Hospital, St Bartholomews Hospital, St James's University Hospital NHS Trust, Velindre Cancer Centre, Western General Hospital, and Weston Park Hospital Cancer Centre study participating centres were added.
5. Wales was added to the Countries of recruitment.
08/07/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 28/02/2022 to 31/12/2024.
2. The overall trial end date was changed from 01/09/2023 to 31/07/2025.
3. The intention to publish date was changed from 01/08/2024 to 31/01/2026.
09/04/2020: Due to current public health guidance, recruitment for this study has been paused.
20/11/2019: The first public contact's details have been deleted.
19/11/2019: The following changes have been made:
1. The recruitment end date has been changed from 30/06/2021 to 28/02/2022.
2. The overall trial end date has been changed from 01/01/2023 to 01/09/2023.
3. The intention to publish date has been changed from 01/12/2023 to 01/08/2024.
4. A second public contact has been added.
14/05/2018: Cancer Research UK lay summary link added to plain English summary field
16/01/2018: Internal review.
16/10/2017: Internal review.
