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
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.
• 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