PRIMUS001: A study looking at two different treatments for pancreatic cancer that has spread to other parts of the body
Trial ID: ISRCTN75002153
Other - Phase 2 - No longer available
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-of-folfox-a-chemotherapy-for-cancer-of-the-pancreas-that-has-spread-primus-001
Conditions
- Metastatic pancreatic cancer
- Cancer
- Metastatic pancreatic cancer
Interventions
- Nab-paclitaxel, gemcitabine, oxaliplatin, folinic acid, 5-fluorouracil
Eligibility
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
- 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
Sponsor
NHS Greater Glasgow and Clyde
Source: https://www.isrctn.com/
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