Metastatic pancreatic cancer Cancer Metastatic pancreatic cancer
Conditions
Interventions
Patients will call the CTU to randomise the patients and they will be randomised on a 1:1 basis with 50% receiving AG and 50% FOLFOX-A. Minimisation will be used to allocate patients between the trea
Sponsors
NHS Greater Glasgow and Clyde
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Patient has been enrolled in the Precision Panc Master Protocol and their tissue has been deemed suitable for NGS analysis 2. Patient has provided signed information consent for the PRIMUS 001 study 3. Age 16 years and over 4. Histologically-confirmed metastatic pancreatic ductal adenocarcinoma and its varients, with measurable metastatic lesion(s) according to RECIST 1.1. 5. Eastern Cooperative Oncology Group (ECOG) 0-1 with life expectation of no less than 12 weeks. 6. 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. 7. Adequate liver/bone marrow function as defined by: 7.1. Neutrophils (ANC) = 1.5 x 109/l 7.2. Platelets = 100 x 109/l 7.3. Haemoglobin = 9.0 g/dL 7.4. WBC = 3 x 109/l 7.5. Total bilirubin = 1.5 x institutional ULN unless bilirubin rise is due to Gilbert’s syndrome 7.6. Aspartate transaminase (AST) and alanine aminotransferase (ALT) = 2.5 x ULN (and <5 ULN in the presence of liver metastases) 7.7. Estimated creatinine clearance = 60 mL/min (as calculated by Cockcroft and Gault or Wright formula or measured by EDTA clearance) 8. 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 9. Woman of child bearing potential, and men with female partners of child bearing potential, must agree to use adequate contraceptive measures (see section 8.1.8.1) for the duration of the study and for up to 6 months after the completion of study treatment. 10. 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 CRUK CTU if this is the case): 11. Patient must be biomarker positive as fed back after central Precision-PANC diagnostic testing
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 12/03/2024: 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 metastatsis or mental illness 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 (DPD) deficiency 10. Pregnant of 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 3 years (other than treated squamous/basal cell skin cancer, treated early-stage cervical cancer or treated/biochemically-stable, organ-confined prostate cancer) 19. Any patient with severe diarrhoea (defined as =grade 3 diarrhoea despite maximum supportive measures and exclusion of underlying infection _____ Previous 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 metastatsis or mental illness 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 (DPD) deficiency 10. Pregnant of 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/bio 18. Chemically-stable, organ-confined prostate cancer) 19. Any patient with severe diarrhoea (defined as =grade 3 diarrhoea despite maximum supportive measures and exclusion of underlying infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival as measured by IV contrast enhanced CT scan every 8 weeks from the date of randomisation to progression or death (from any cause), whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Objective response rate based on RECIST v1.1 will be measured by contrast enchanged CT scan every 8 weeks until disease progression 2. Overall survival will be recorded at each study visit up to 60 months post randomisation 3. Safety and tolerability will be assessed using NCI-CTCAE v4. Adverse events will be collected at each treatment visit and the end of treatment visit. 4. Quality of life will be assessed using EORTC QLQ-C30, QLQ PAN26, ED-5D-5L monthly while on treatment and then at each follow up visit 5. Peripheral neuropathy will be assessed by the GOG-NTX4 questionnaire monthly while on treatment and then at each follow up visit 6. Health Economics: Resource use will be assessed by the EQ-5d-5L monthly while on treatment and then at each follow up visit. Information will also be collected regarding any inpatients stays in hospital during the course of the study | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactLaura Cunningham
Outcome results
None listed