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Neoplasms PancreaticPhase 2NCT04151277

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

A Phase 2 study testing FOLFOX-A, Gemcitabe and Abraxane and G-CSF in people with Neoplasms Pancreatic, run by Judith Dixon-Hughes at 30 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Neoplasms Pancreatic
What is being tested?
FOLFOX-A, Gemcitabe and Abraxane and G-CSF
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
30 sitesUnited Kingdom
Study dates
28 Nov 2017to 31 Jan 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • 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 Cancer Research UK (CRUK) Clinical Trials Unit (CTU) if this is the case) 12. Patient must be biomarker positive as fed back after central Precision-Panc diagnostic testing

Who cannot join

  • 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
Show all 18Show fewer
  • 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
  • Any patients receiving treatment with brivudin, sorivudin and analogues
  • 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)
  • Any patient with severe diarrhoea (defined as ≥grade 3 diarrhoea despite maximum supportive measures and exclusion of underlying infection)

Trial locations and contacts

30 sites in 1 country.

Sarah Bradley contact

01413017540

sarah.bradley@glasgow.ac.uk

Judith Dixon-Hughes contact

01413302718

judith.dixon@glasgow.ac.uk

30 sites in 1 country

United Kingdom30 sites, 30 recruiting

  • Aberdeen Royal Infirmary

    Aberdeen

    Angela Cheyne, angela.cheyne@nhs.net

    Ishtiaq Zubairi

    Recruiting

  • Northern Ireland Cancer Centre

    Belfast

    Marie Shannon, Marie.Shannon@belfasttrust.hscni.net

    Martin Eatock

    Recruiting

  • Queen Elizabeth Hospital

    Birmingham

    Catie Guerreiro, Catia.Guerreiro@uhb.nhs.uk

    Yuk Ting Ma

    Recruiting

  • Royal Bournemouth Hospital

    Bournemouth

    Christina Fynn, Christina.Penny@rbch.nhs.uk

    Tamas Hickish

    Recruiting

  • Bristol Oncology Centre

    Bristol

    Sharon Short, Sharon.Short@UHBristol.nhs.uk

    Stephen Falk

    Recruiting

  • Addenbrooke's Hospital

    Cambridge

    Rhosyll Gabriel, rhosyll.gabriel@addenbrookes.nhs.uk

    Pippa Corrie

    Recruiting

  • Castle Hill Hospital

    Cottingham

    Magda Kolodziej, magdalena.kolodziej@hey.nhs.uk

    Anthony Maraveyas

    Recruiting

  • Ninewells Hospital

    Dundee

    Helen Cumming, helencumming@nhs.net

    Asa Dahle Smith

    Recruiting

  • Western General

    Edinburgh

    Olga Demyanov

    Alan Christie

    Recruiting

  • Beatson West of Scotland Cancer Centre

    Glasgow

    Ray Syed, Rasheeq.Syed@glasgow.ac.uk

    Janet Graham

    Recruiting

  • Huddersfield Royal Infirmary

    Huddersfield, HD3 3EA

    Zuleikha Mulla, zuleikha.mulla@cht.nhs.uk

    Emma Rathbone

    Recruiting

  • Raigmore Hospital

    Inverness

    Laura McLennan

    Walter Mmeka

    Recruiting

  • St James's University Hospital

    Leeds

    Sarah Wetherop, sarah.wetherop@nhs.net

    Fiona Collinson

    Recruiting

  • The Clatterbridge Cancer Centre

    Liverpool, CH63 4JY

    Lorraine Broadfoot, lorraine.broadfoot@nhs.net

    Daniel Palmer

    Recruiting

  • Guy's Hospital

    London

    Christina Armoogum

    Debashis Sarker

    Recruiting

  • Imperial College Healthcare Trust

    London

    Sarah Stimpson, sarah.stimpson@nhs.net

    Harpreet Wasan

    Recruiting

  • Royal Free London Hospital

    London

    Jennifer Fraser-Fish, j.fraser-fish@nhs.net

    Roopinder Gillmore

    Recruiting

  • Royal Marsden Hospital

    London

    Andrea Turner, Andrea.Turner@rmh.nhs.uk

    Naureen Starling

    Recruiting

  • St Bart's Hospital

    London

    Sultana Begum, sultana.begum16@nhs.net

    David Propper

    Recruiting

  • St George's Hospital

    London

    Chandni Patel, Chandni.Patel@stgeorges.nhs.uk

    Anna-Mary Young

    Recruiting

  • University College London Hospital

    London

    Isabelle Brown, isabelle.brown@nhs.net

    Daniel Hochhauser

    Recruiting

  • The Christie, Manchester

    Manchester

    Sophie Walker, Sophie.Walker@christie.nhs.uk

    Juan Valle

    Recruiting

  • Milton Keynes General Hospital

    Milton Keynes

    Chloe Green, chloe.green@mkuh.nhs.uk

    Wasiru Saka

    Recruiting

  • Freeman Hospital

    Newcastle

    Hazel Maines, Hazel.Maines@nuth.nhs.uk

    Jane Margetts

    Recruiting

  • Nottingham University Hospital

    Nottingham

    Kerri Jenkins, Kerri.Jenkins@nuh.nhs.uk

    Arora Arvind

    Recruiting

  • Churchill Hospital

    Oxford

    Sheeba Vuppusetty, sheeba.vuppusetty@ohu.nhs.uk

    Kinnari Patel

    Recruiting

  • Poole Hospital

    Poole

    Rachel Barnsley, rachel.barnsley@poole.nhs.uk

    Rachel Plant

    Recruiting

  • Weston Park

    Sheffield

    Cyper Allan, c.allan@sheffield.ac.uk

    Jonathan Wadsley

    Recruiting

  • University of Southampton Hospital

    Southampton

    Liane Armstrong, liane.armstrong@uhs.nhs.uk

    Andrew Bateman

    Recruiting

  • Singleton Hospital

    Swansea

    Karen Phillips, karen.phillips6@wales.nhs.uk

    Steve Kihara

    Recruiting

Other trials in United Kingdom

About this study

Official 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

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.

Read the detailed 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.

Being tested
FOLFOX-A, Gemcitabe and Abraxane, G-CSF
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FOLFOX-ADrug

    Patients will recieve nab-paclitaxel, oxaliplatin, Folinic Acid and 5-FU in a 14 day cycle

  • Gemcitabe and AbraxaneDrug

    Patients will receive gemcitabine and nab-paclitaxel 3 weeks out of 4

  • G-CSFDrug

    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

Study groups in NCT04151277
Study groupRoleWhat they receive
FOLFOX-AExperimental* 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))
Receives: Drug: FOLFOX-A; Drug: G-CSF
Abraxane and GemcitabineActive 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)
Receives: Drug: Gemcitabe and Abraxane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival

    Progression free survival as measured froim the date of randomisation to progression or death (from any cause)

    Measured: At time of progression (estimated to be between 5 and 7.5 months)

Secondary outcomes (10)

  1. Ojective Response Rate

    Based on RECIST version 1.1

    Measured: Measured every 8 weeks by CT scan (most patients will received 3-4 CT scans over 24-32 weeks))

  2. Overall Survival

    Survival will be measured from the date of randomisation and include all caused of death

    Measured: 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

  3. Safety and Tolerability of FOLFOX-A treatment

    Using NCI-CTCAE version 4.03

    Measured: 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)

  4. Safety and Tolerability of AG treatment

    Using NCI-CTCAE version 4.03

    Measured: 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)

  5. Quality of Life (EORTC QLQ-C30)

    patients will complete the EORTC QLQ-C30 questionnaire at clinic

    Measured: 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).

  6. Peripheral Neuropathy

    Measured by GOG-NTX4

    Measured: Every 4 weeks while on treatment, at end of treatment visit and at follow-up visits (6, 9, 12, 18, 24, 36, 48 and 60 months post randomisation).

  7. Health Economics as defined to hospital resource use i.e how many nights the patient has spent in hospital and how may times they have attended hospital since the last time they were seen

    Resource use will be assessed during the course of the study

    Measured: At each study visit. Patient will be followed up for up to 5 years post randomistation (6, 9, 12, 18, 24, 36, 48 and 60 months post randomisation).

  8. Biomarker Discovery and Development

    This will be ongoing as part of the study. This will use trial material but will be extrinsic to the trials outcomes. The biomarker will be specificed and locked down before the first interim analysis that is biomarker dependent

    Measured: Ongoing during study. Recruitment will take 46 months and patients will be followed-up for up to 5 years post randomisation

  9. Quality of Life (EORTC QLQ-PAN26)

    patients will complete the EORTC QLQ-PAN26 questionnaire at clinic

    Measured: 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).

  10. Quality of Life (EQ-5D-5L)

    patients will complete the EQ-5D-5L questionnaire at clinic

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2019
  2. Study start28 Nov 2017
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be randomised to each of the treatments 1:1
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04151277
Sponsor's protocol ID
PRIMUS0012016
Status last verified
Feb 2024
First submitted
25 Oct 2019
Last updated
8 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FOLFOX-A, Gemcitabe and Abraxane and G-CSF in people with Neoplasms Pancreatic, run by Judith Dixon-Hughes at 30 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sarah Bradley (01413017540, sarah.bradley@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (time frame: At time of progression (estimated to be between 5 and 7.5 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04151277.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.

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