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

Who is this study for? Patients with metastatic pancreatic cancer
Status: Recruiting
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:

• 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

• 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

Locations
Other Locations
United Kingdom
Aberdeen Royal Infirmary
RECRUITING
Aberdeen
Northern Ireland Cancer Centre
RECRUITING
Belfast
Queen Elizabeth Hospital
RECRUITING
Birmingham
Royal Bournemouth Hospital
RECRUITING
Bournemouth
Bristol Oncology Centre
RECRUITING
Bristol
Addenbrooke's Hospital
RECRUITING
Cambridge
Castle Hill Hospital
RECRUITING
Cottingham
Ninewells Hospital
RECRUITING
Dundee
Western General
RECRUITING
Edinburgh
Beatson West of Scotland Cancer Centre
RECRUITING
Glasgow
Huddersfield Royal Infirmary
RECRUITING
Huddersfield
Raigmore Hospital
RECRUITING
Inverness
St James's University Hospital
RECRUITING
Leeds
The Clatterbridge Cancer Centre
RECRUITING
Liverpool
Guy's Hospital
RECRUITING
London
Imperial College Healthcare Trust
RECRUITING
London
Royal Free London Hospital
RECRUITING
London
Royal Marsden Hospital
RECRUITING
London
St Bart's Hospital
RECRUITING
London
St George's Hospital
RECRUITING
London
University College London Hospital
RECRUITING
London
The Christie, Manchester
RECRUITING
Manchester
Milton Keynes General Hospital
RECRUITING
Milton Keynes
Freeman Hospital
RECRUITING
Newcastle
Nottingham University Hospital
RECRUITING
Nottingham
Churchill Hospital
RECRUITING
Oxford
Poole Hospital
RECRUITING
Poole
Weston Park
RECRUITING
Sheffield
University of Southampton Hospital
RECRUITING
Southampton
Singleton Hospital
RECRUITING
Swansea
Contact Information
Primary
Sarah Bradley
sarah.bradley@glasgow.ac.uk
01413017540
Backup
Judith Dixon-Hughes
judith.dixon@glasgow.ac.uk
01413302718
Time Frame
Start Date: 2017-11-28
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 500
Treatments
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 and day 2 (for a total dose of 2400mg/m2 over 46 hours (or 48 hours as per standard practice))
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)
Related Therapeutic Areas
Sponsors
Leads: Judith Dixon-Hughes
Collaborators: NHS Greater Glasgow and Clyde, University of Glasgow

This content was sourced from clinicaltrials.gov