Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Oxaliplatin

Leucovorin

Fluorouracil

Levoleucovorin

Folic Acid

Folinic Acid

Folate

Vitamin B9

* 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))

* 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)

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

FOLFOX-A

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

Gemcitabe and Abraxane

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

G-CSF

Sarah Bradley

Judith Dixon-Hughes

Angela Cheyne

Ishtiaq Zubairi

Marie Shannon

Martin Eatock

Catie Guerreiro

Yuk Ting Ma

Christina Fynn

Tamas Hickish

Sharon Short

Stephen Falk

Rhosyll Gabriel

Pippa Corrie

Magda Kolodziej

Anthony Maraveyas

Helen Cumming

Asa Dahle Smith

Olga Demyanov

Alan Christie

Ray Syed

Janet Graham

Zuleikha Mulla

Emma Rathbone

Laura McLennan

Walter Mmeka

Sarah Wetherop

Fiona Collinson

Lorraine Broadfoot

Daniel Palmer

Christina Armoogum

Debashis Sarker

Sarah Stimpson

Harpreet Wasan

Jennifer Fraser-Fish

Roopinder Gillmore

Andrea Turner

Naureen Starling

Sultana Begum

David Propper

Chandni Patel

Anna-Mary Young

Isabelle Brown

Daniel Hochhauser

Sophie Walker

Juan Valle

Chloe Green

Wasiru Saka

Hazel Maines

Jane Margetts

Kerri Jenkins

Arora Arvind

Sheeba Vuppusetty

Kinnari Patel

Rachel Barnsley

Rachel Plant

Cyper Allan

Jonathan Wadsley

Liane Armstrong

Andrew Bateman

Karen Phillips

Steve Kihara

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.

Patients will be randomised to each of the treatments 1:1

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

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

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

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

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

patients will complete the EORTC QLQ-C30 questionnaire at clinic

Resource use will be assessed during the course of the study

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

Spots Global Cancer Trial Database for gemcitabe and abraxane