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Neoplasms PancreaticPhase 2PRIMUS002NCT04176952

PRIMUS002: Looking at 2 Neo-adjuvant Treatment Regimens for Resectable and Borderline Resectable Pancreatic Cancer

A Phase 2 study testing FOLFOX-A and AG in people with Neoplasms Pancreatic, run by Judith Dixon-Hughes at 3 sites in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

PRIMUS 002 is looking at 2 different chemotherapy regimens in the neo-adjuvant setting for pancreatic cancer. Each treatment will be given for 3 months prior to surgery 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 and AG
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
3 sitesUnited Kingdom
Study dates
5 Mar 2019to 19 Aug 2021
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 and their tissue has been deemed suitable for Next Generation Sequencing analysis (a Precision-Panc Master Protocol identifier will be required at the time of study enrolment)
  • Signed informed consent given for PRIMUS 002 study
  • Age ≥ 16 years
  • Resectable or borderline resectable pancreatic cancer as defined by National Comprehensive Cancer Network criteria following discussion at the Multi Disciplinary Team
  • Measurable Disease as per RECIST 1.1
  • Histological or cytologically proven pancreatic ductal adenocarcinoma (including variants)
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  • Able to undergo biliary drainage using a covered or partially covered self-expanding metal stent if jaundiced
  • Eastern Cooperative Oncology Group performance status 0 and 1
  • Adequate liver/bone marrow function as defined by:
  • Neutrophils (ANC) ≥ 1.5 x 109/l
  • Platelets ≥ 100 x 109/l
  • Haemoglobin ≥ 9.0g/dL
  • White Blood Cells (WBC) ≥ 3 x 109/l
  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) unless bilirubin rise is due to Gilbert's syndrome
  • Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN (or <5 x 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)
  • 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
  • Woman of child bearing potential, and men with female partners of child bearing potential, must agree to use adequate contraceptive measures (see section 7.1.11.1) for the duration of the study and for up to 6 months after the completion of study treatment.
  • Able to comply with protocol requirements and deemed fit for surgical resection, chemotherapy and CRT

Who cannot join

  • Distant metastatic disease
  • History of previous or concurrent malignancy diagnosis (except curatively treated basal cell carcinoma of skin or carcinoma in situ of cervix) in the last 3 years
  • Prior chemotherapy or CRT for pancreatic cancer
  • Known hypersensitivity for any component of any study drug
  • Active infection including Herpes Zoster and chickenpox
  • Uncontrolled congestive heart failure (CHF), or history of myocardial ischemia (MI), unstable angina, stroke, or transient ischemia within previous 6 months.
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  • Serious medical or psychological condition precluding neo-adjuvant treatment and surgical resection
  • New York Heart Association Classification Grade III or IV
  • Liver cirrhosis (except for Child-Pugh A)
  • Major surgery within 28 days prior to trial entry
  • Any patients receiving treatment with brivudin, sorivudin and analogues or patients who have not stopped these drugs at least 4 weeks prior to the start of study treatment
  • Any patient with severe diarrhoea (defined as ≥grade 3 diarrhoea despite maximum supportive measures and exclusion of underlying infection)
  • Patients with known malabsorption
  • Patients with known or suspected dihydropyrimidine dehydrogenase (DPD) deficiency
  • Grade ≥ 2 peripheral neuropathy
  • Administration of any investigational drug within 28 days or 5 half-lives, whichever is longer, prior to receiving the first dose of trial treatment

Trial locations and contacts

3 sites in 1 country.

United Kingdom3 sites

  • Western General

    Edinburgh

  • Beatson West of Scotland Cancer Centre

    Glasgow

  • Royal Free Hospital

    London

Other trials in United Kingdom

About this study

Official title: PRIMUS002: An Umbrella Phase II Study Examining Two Neo-adjuvant Regimens (FOLFOX-A and AG) in Resectable and Borderline Resectable Pancreatic Ductal AdenoCarcinoma (PDAC), Focusing on Biomarker and Liquid Biopsy Development

PRIMUS 002 is looking at 2 different chemotherapy regimens in the neo-adjuvant setting for pancreatic cancer. Each treatment will be given for 3 months prior to surgery

Read the detailed description

This is an integrated, open label, non-randomised, phase II trial of 2 neo-adjuvant regimens (FOLFOX-A and AG) assessing efficacy and toxicity with integrated translational work. The study is powered on testing a proposed DNA damage response deficient biomarker for responsiveness in patients treated with FOLFOX-A; patients being treated with AG are recruited concurrently. The study has a prospective safety assessment of neo-adjuvant chemotherapy and neo-adjuvant chemotherapy followed by chemoradiotherapy consisting of conventional radiotherapy with concomitant capecitabine. This safety assessment will include all patients (FOLFOX-A and AG)

Being tested
FOLFOX-A, AG
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

    • nab-paclitaxel: 150mg/m2 IV over 30 minutes, day 1 (administered first).
    • Oxaliplatin: 85mg/m2, IV over 2 hours, day 1.
    • Folinic acid: 350mg flat dose, IV over 2 hours, day 1.
    • Fluorouracil 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 local practice.)

  • AGDrug

    • nab-paclitaxel: 125mg/m2 IV over 30 minutes on days 1, 8 and 15 (administered first).
    • Gemcitabine 1000mg/m2 IV over 30 minutes on days 1, 8 and 15 (immediately following nab-paclitaxel).
Study groups in NCT04176952
Study groupRoleWhat they receive
FOLFOX-AExperimentalFOLFOX A arm (14-day cycle) * nab-paclitaxel: 150mg/m2 IV over 30 minutes, day 1 (administered first). * Oxaliplatin: 85mg/m2, IV over 2 hours, day 1. * Folinic acid: 350mg flat dose, IV over 2 hours, day 1. * Fluorouracil 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 local practice.) Patients will also receive daily G-CSF as primary prophylaxis against neutropenic events for all cycles. This should be given as per local policy for chemotherapy regimens given every 14 days e.g. it may be started on day 4 for 7 days (preparation and dose should be given as per local policy).
Receives: Drug: FOLFOX-A
Abraxane and GemcitabineActive comparatorNab-Paclitaxel + Gemcitabine (AG) arm (28-day cycle) * nab-paclitaxel: 125mg/m2 IV over 30 minutes on days 1, 8 and 15 (administered first). * Gemcitabine 1000mg/m2 IV over 30 minutes on days 1, 8 and 15 (immediately following nab-paclitaxel).
Receives: Drug: AG

What is being measured

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

  1. Time to progression post FOLFOX-A induction treatment

    date of progression after FOLFOX-A neo-adjuvant chemotherapy as assessed by RECIST 1.1

    Measured: CT scans will take place at baseline, pre chemoradiotherapy and pre surgery, over approximately 6 months

Secondary outcomes (13)

  1. Proving liquid biopsies can be used to define patient subgroups

    a liquid biopsy will be taken and analysed using circulating tumour DNA at different timepoints to see if these can be used to define patient subgroups

    Measured: From date of registration to date of surgery. On average 4 months after registration

  2. Response post neo-adjuvant chemotherapy

    CT scans will be reported to RECIST 1.1 and best response will be evaluated

    Measured: CT scan will be performed at baseline and then post neo-adjuvant chemotherapy (approximately 3 months later)

  3. College of American Pathologists tumour regression grade

    CAP tumour regression grade (grade 0-3 with 0 being no viable residual tumour and 3 being poor to no response) will be assessed post surgery

    Measured: Post surgery which will be approximately 4 months post registration

  4. R0 rate post surgery

    R0 rate will be assessed post surgery

    Measured: Post surgery which will be approximately 4 months post registration

  5. Overall survival

    Overall survival will be assessed in all patients

    Measured: From date of registration until date of death assessed for up to 5 years post registration

  6. Disease free survival

    Disease free survival will be assessed at every follow up visit

    Measured: from date of registration until date of disease recurrence assessed for at least 24 months post registration

  7. Safety and tolerability of study drugs: NCI CTCAE 4.03

    Safety and tolerability will be assessed as per NCI CTCAE 4.03

    Measured: Assessed at every clinic visit during treatment, for approximately 3 months post registration

  8. Safety and tolerability of chemoradiotherapy: NCI CTCAE 4.03

    Safety and tolerability of chemoradiotherapy will be assessed as per NCI CTCAE 4.03

    Measured: Assessed at every chemoradiotherapy visit and pre-surgery (once Chemoradiotherapy added). Chemoradiotherapy will take place 5 days a week for three weeks

  9. Surgical complication rate

    Rate of surgical complication as assessed by NCI CTCAE 4.03

    Measured: Assessed post surgery, approximately 4 months post registration

  10. Neurotoxicity

    Assessed by GOG NTX4 (4 questions graded from 0 (not at all) to 4 (very much). quality of life will be assessed using the GOG NTX4 tool at the following timepoints: Baseline, month 1, month 2, month 3, pre chemoradiotherapy, between fraction 11 and 15 of chemoradiotherapy, pre surgery, at every follow-up visit (6, 9, 12 months post registration then every 6 months)

    Measured: Neurotoxicity will be assessed from registration until study is completed at various timepoints until patient death. Each patient will be followed up for at least 24 months post registration

  11. Quality of life assessed by EORTC QLQ-C30

    quality of life will be assessed using the EORTC QLQ C30 tool at the following timepoints: Baseline, month 1, month 2, month 3, pre chemoradiotherapy, between fraction 11 and 15 of chemoradiotherapy, pre surgery, at every follow-up visit (6, 9, 12 months post registration then every 6 months for a minimum of 24 months). The Quality of life tool is comprised of 28 questions that the patient answers either 1-4 (1 = not at all, 4 = Very much) and 2 questions that are on al scale of 1 - 7 where 1 = very poor and 7 = excellent

    Measured: Quality of life will be assessed from registration until study is completed at various timepoints until patient death. Each patient will be followed up for at least 24 months post registration

  12. Quality of life assessed by EORTC QLQ-PAN26

    quality of life will be assessed using the EORTC QLQ-PAN26 tool at the following timepoints: Baseline, month 1, month 2, month 3, pre chemoradiotherapy, between fraction 11 and 15 of chemoradiotherapy, pre surgery, at every follow-up visit (6, 9, 12 months post registration then every 6 months for a minimum of 24 months). The Quality of life tool is comprised of 26 questions that the patient answers either 1-4 (1 = not at all, 4 = Very much)

    Measured: Quality of life will be assessed from registration until study is completed at various timepoints until patient death. Each patient will be followed up for at least 24 months post registration

  13. Health Economics

    Health economics defined as number of visits to hospital per patient, both as an inpatient and as an outpatient will be assessed at the following timepoints: Baseline, month 1, month 2, month 3, pre chemoradiotherapy, between fraction 11 and 15 of chemoradiotherapy, pre surgery, at every follow-up visit (6, 9, 12 months post registration then every 6 months for a minimum of 24 months)

    Measured: Health economics will be assessed from registration until study is completed at various timepoints until patient death. Each patient will be followed up for at least 24 months post registration

Timeline

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

  1. First posted26 Nov 2019
  2. Study start5 Mar 2019
  3. Primary completion19 Aug 2021
  4. Study completion19 Aug 2021

Why it stopped: Due to funding being withdrawn

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
Non-randomised
Intervention model
Parallel groups
Model description
Patients are registered to receive either FOLFOX-A or AG depending on their age and performance status
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04176952
Sponsor's protocol ID
PRIMUS0022016
Acronym
PRIMUS002
Status last verified
May 2022
First submitted
28 Oct 2019
Last updated
24 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Clinical data will be made available on request once clinical study report has been written and primary publication accepted by peer reviewed journal

Publications

  • Dreyer SB, Bryce A, Froeling F, Jackson S, Santana L, Dickson EJ, Coats M, McKay C, Holroyd D, Biankin AV, Jamieson NB, Chang DK. Clinical and molecular landscape of surgically resected early onset pancreatic cancer. Br J Surg. 2026 May 7;113(5):znag032. doi: 10.1093/bjs/znag032.

    PubMed 42095609

  • Saha A, Wadsley J, Sirohi B, Goody R, Anthony A, Perumal K, Ulahanan D, Collinson F. Can Concurrent Chemoradiotherapy Add Meaningful Benefit in Addition to Induction Chemotherapy in the Management of Borderline Resectable and Locally Advanced Pancreatic Cancer?: A Systematic Review. Pancreas. 2023 Jan 1;52(1):e7-e20. doi: 10.1097/MPA.0000000000002215.

    PubMed 37378896

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FOLFOX-A and AG in people with Neoplasms Pancreatic, run by Judith Dixon-Hughes at 3 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 19 inclusion and 16 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: stopped early, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

The study was stopped early (reason given: Due to funding being withdrawn). Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to progression post FOLFOX-A induction treatment (time frame: CT scans will take place at baseline, pre chemoradiotherapy and pre surgery, over approximately 6 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 NCT04176952, which also lists 2 linked publications.

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 24 May 2022.

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