PRIMUS002: Looking at 2 Neo-adjuvant Treatment Regimens for Resectable and Borderline Resectable Pancreatic Cancer

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

PRIMUS 002 is looking at 2 different chemotherapy regimens in the neo-adjuvant setting for pancreatic cancer. Each treatment will be given for 3 months prior to surgery

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Judith Dixon-Hughes
• Collaborators: NHS Greater Glasgow and Clyde; University of Glasgow
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel

Criteria

Inclusion Criteria:

1. Patient has been enrolled in the Precision-Panc Master Protocol and their tissue has been deemed suitable for Next Generation Sequencing analysis (a Precision-Panc Master Protocol identifier will be required at the time of study enrolment)

2. Signed informed consent given for PRIMUS 002 study

3. Age ≥ 16 years

4. Resectable or borderline resectable pancreatic cancer as defined by National Comprehensive Cancer Network criteria following discussion at the Multi Disciplinary Team

5. Measurable Disease as per RECIST 1.1

6. Histological or cytologically proven pancreatic ductal adenocarcinoma (including variants)

7. Able to undergo biliary drainage using a covered or partially covered self-expanding metal stent if jaundiced

8. Eastern Cooperative Oncology Group performance status 0 and 1

9. Adequate liver/bone marrow function as defined by:

1. Neutrophils (ANC) ≥ 1.5 x 109/l

2. Platelets ≥ 100 x 109/l

3. Haemoglobin ≥ 9.0g/dL

4. White Blood Cells (WBC) ≥ 3 x 109/l

5. Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) unless bilirubin rise is due to Gilbert's syndrome

6. Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN (or <5 x 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)

10. 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

11. Woman of child bearing potential, and men with female partners of child bearing potential, must agree to use adequate contraceptive measures (see section 7.1.11.1) for the duration of the study and for up to 6 months after the completion of study treatment.

12. Able to comply with protocol requirements and deemed fit for surgical resection, chemotherapy and CRT

Exclusion Criteria:

1. Distant metastatic disease

2. History of previous or concurrent malignancy diagnosis (except curatively treated basal cell carcinoma of skin or carcinoma in situ of cervix) in the last 3 years

3. Prior chemotherapy or CRT for pancreatic cancer

4. Known hypersensitivity for any component of any study drug

5. Active infection including Herpes Zoster and chickenpox

6. Uncontrolled congestive heart failure (CHF), or history of myocardial ischemia (MI), unstable angina, stroke, or transient ischemia within previous 6 months.

7. Serious medical or psychological condition precluding neo-adjuvant treatment and surgical resection

8. New York Heart Association Classification Grade III or IV

9. Liver cirrhosis (except for Child-Pugh A)

10. Major surgery within 28 days prior to trial entry

11. Any patients receiving treatment with brivudin, sorivudin and analogues or patients who have not stopped these drugs at least 4 weeks prior to the start of study treatment

12. Any patient with severe diarrhoea (defined as ≥grade 3 diarrhoea despite maximum supportive measures and exclusion of underlying infection)

13. Patients with known malabsorption

14. Patients with known or suspected dihydropyrimidine dehydrogenase (DPD) deficiency

15. Grade ≥ 2 peripheral neuropathy

16. Administration of any investigational drug within 28 days or 5 half-lives, whichever is longer, prior to receiving the first dose of trial treatment