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Clinical Trial Record

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

2017-11-28

2025-12-31

2026-01-31

500

Study Overview

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

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.

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.

  • Neoplasms Pancreatic
  • DRUG: FOLFOX-A
  • DRUG: Gemcitabe and Abraxane
  • DRUG: G-CSF
  • PRIMUS0012016

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2019-10-25  

N/A  

2024-02-07  

2019-11-01  

N/A  

2024-02-08  

2019-11-05  

N/A  

2024-02  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: 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

DRUG: FOLFOX-A

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

DRUG: 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
ACTIVE_COMPARATOR: 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)

DRUG: Gemcitabe and Abraxane

  • Patients will receive gemcitabine and nab-paclitaxel 3 weeks out of 4
Primary Outcome MeasuresMeasure DescriptionTime Frame
Progression Free SurvivalProgression 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 Outcome MeasuresMeasure DescriptionTime Frame
Ojective Response RateBased on RECIST version 1.1Measured every 8 weeks by CT scan (most patients will received 3-4 CT scans over 24-32 weeks))
Overall SurvivalSurvival will be measured from the date of randomisation and include all caused of deathFrom 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 treatmentUsing NCI-CTCAE version 4.03At 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 treatmentUsing NCI-CTCAE version 4.03At 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)patients will complete the EORTC QLQ-C30 questionnaire at clinicEvery 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).
Peripheral NeuropathyMeasured by GOG-NTX4Every 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).
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 seenResource use will be assessed during the course of the studyAt 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).
Biomarker Discovery and DevelopmentThis 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 dependentOngoing during study. Recruitment will take 46 months and patients will be followed-up for up to 5 years post randomisation
Quality of Life (EORTC QLQ-PAN26)patients will complete the EORTC QLQ-PAN26 questionnaire at clinicEvery 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).
Quality of Life (EQ-5D-5L)patients will complete the EQ-5D-5L questionnaire at clinicEvery 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).

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Sarah Bradley

Phone Number: 01413017540

Email: sarah.bradley@glasgow.ac.uk

Study Contact Backup

Name: Judith Dixon-Hughes

Phone Number: 01413302718

Email: judith.dixon@glasgow.ac.uk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
16 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Patient has been enrolled in the Precision-Panc Master Protocol 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
    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
    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 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • NHS Greater Glasgow and Clyde
  • University of Glasgow
  • PRINCIPAL_INVESTIGATOR: Janet Graham, NHS Greater Glasgow and Clyde

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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