pancreatic cancer
Conditions
Interventions
Arm 1:
S1 will be given for 14 consecutive days, twice daily, followed by 2 weeks
rest. Nal-IRI will be administered as an intravenous infusion on day 1 and 15.
Courses of treatment will be repeated
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Able to understand and provide written informed consent >= 18 years of age Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas Documented metastatic disease Previously treated with gemcitabine or gemcitabine containing therapy, or progression within 6 months of adjuvant gemcitabine treatment Adequate hepatic, renal and hematological function
Exclusion criteria
Exclusion criteria: WHO 0-1 Any clinically significant gastrointestinal disorder, including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea > grade 2 Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) in last 6 months NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure. Or known abnormal ECG with clinically significant abnormal findings Active infection or an unexplained fever >38.5°C (excluding tumor fever), which in the physician*s opinion might compromise the patient*s health Current use or any use in last two weeks of strong CYP3A-enzyme inducers/inhibitors and/or strong UGT1A inhibitors Known hypersensitivity to any of the components of liposomal irinotecan (nal-IRI) other liposomal irinotecan formulations, irinotecan, fluoropyrimidines, or leucovorin. Hypersensitivity to any of the active substances (tegafur, gimeracil, and oteracil) Previous treatment with fluoropyrimidine therapy Known dihydropyrimidine dehydrogenase (DPD) deficiency Breast feeding, known pregnancy, positive serum pregnancy test or unwillingness to use a reliable method of birth control, during therapy and for 3 months following the last dose of liposomal irinotecan (nal-IRI). Treatment within 4 weeks with DPD inhibitors, including sorivudine or its chemically related analogues such as brivudine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Run in phase: Dose limiting toxicity (DLT) and Maximal tolerated dose (MTD) of nal-IRI when co-administered with fixed dose S1 in patients with metastatic pancreatic cancer. Phase II part: Efficacy between the treatment arms in terms of progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival Response rate according to RECIST 1.1 Adverse events according to NCI CTC version 4.0 Quality of life | — |
Countries
Netherlands
Outcome results
None listed