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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
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
Progression Free Survival
Progression free survival as measured froim the date of randomisation to progression or death (from any cause)
Time frame: At time of progression (estimated to be between 5 and 7.5 months)
Ojective Response Rate
Based on RECIST version 1.1
Time frame: Measured every 8 weeks by CT scan (most patients will received 3-4 CT scans over 24-32 weeks))
Overall Survival
Survival will be measured from the date of randomisation and include all caused of death
Time frame: 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
Using NCI-CTCAE version 4.03
Time frame: 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
Using NCI-CTCAE version 4.03
Time frame: 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)
patients will complete the EORTC QLQ-C30 questionnaire at clinic
Time frame: 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).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
RECRUITINGNorthern Ireland Cancer Centre
Belfast, United Kingdom
RECRUITINGQueen Elizabeth Hospital
Birmingham, United Kingdom
RECRUITINGRoyal Bournemouth Hospital
Bournemouth, United Kingdom
RECRUITINGBristol Oncology Centre
Bristol, United Kingdom
RECRUITINGAddenbrooke's Hospital
Cambridge, United Kingdom
RECRUITINGCastle Hill Hospital
Cottingham, United Kingdom
RECRUITINGNinewells Hospital
Dundee, United Kingdom
RECRUITINGWestern General
Edinburgh, United Kingdom
RECRUITINGBeatson West of Scotland Cancer Centre
Glasgow, United Kingdom
RECRUITING...and 20 more locations
Peripheral Neuropathy
Measured by GOG-NTX4
Time frame: 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).
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
Time frame: 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).
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
Time frame: Ongoing 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 clinic
Time frame: 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).
Quality of Life (EQ-5D-5L)
patients will complete the EQ-5D-5L questionnaire at clinic
Time frame: 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).