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

Launched by JUDITH DIXON-HUGHES · Nov 1, 2019

Keywords

ClinConnect Summary

The PRIMUS 001 trial is a study designed to compare two different combinations of chemotherapy for patients with metastatic pancreatic cancer, which is a type of cancer that has spread beyond the pancreas. In this trial, half of the participants will receive a treatment called FOLFOX-A, while the other half will receive AG. The goal is to see which treatment works better for slowing down the disease. Participants will continue receiving treatment until their cancer progresses, they decide to stop, or if they experience severe side effects.

To be eligible for this trial, participants must be at least 16 years old and have a confirmed diagnosis of pancreatic ductal adenocarcinoma, which is the most common type of pancreatic cancer. They should have measurable cancer that has spread and must not have received chemotherapy for metastatic disease before. Additionally, participants need to meet certain health criteria to ensure they can safely receive the treatments. Those considering joining the trial should know that they will be closely monitored throughout the study and will need to provide consent to participate. This trial is currently recruiting participants, and it’s important for anyone interested to discuss it with their healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient has been enrolled in the Precision-Panc Master Protocol
• • 2. Patient has provided signed information consent for the PRIMUS 001 study
• • 3. Age ≥ 16 years
• • 4. Histologically-confirmed pancreatic ductal adenocarcinoma and its varients
• • 5. Measurable metastatic disease according to RECIST V1.1
• • 6. Eastern Cooperative Oncology Group (ECOG) 0-1 with life expectation of no less than 12 weeks
• • 7. 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
• 8. Adequate liver/bone marrow function as defined by:
• • 1. Neutrophils (ANC) ≥ 1.5 x 109/l
• • 2. Platelets ≥ 100 x 109/l
• • 3. Haemoglobin ≥ 9.0 g/dL
• • 4. White Blood Cells (WBC) ≥ 3 x 109/l
• • 5. Total bilirubin ≤ 1.5 x institutional ULN unless bilirubin rise is due to Gilbert's syndrome
• • 6. Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN ( \<5 ULN in the presence of liver metastases)
• • 7. 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
• 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 metastasis
• • 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 dehydrogenase (DPD) deficiency
• • 10. Pregnant or 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/biochemically-stable organ-confined prostate cancer)
• • 18. Any patient with severe diarrhoea (defined as ≥grade 3 diarrhoea despite maximum supportive measures and exclusion of underlying infection)