Randomised study for second line treatment with nal-IRI and S1 in pancreatic cancer.

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 120

Inclusion Criteria

1. Able to understand and provide written informed consent
2. = 18 years of age
3. Histologically or cytologically confirmed adenocarcinoma of pancreas
4. Documented metastatic disease, according to RECIST 1.1.
5. Previously treated with gemcitabine or gemcitabine containing therapy, or progression within 6 months of adjuvant gemcitabine based treatment
6. Adequate hepatic, renal and hematological function
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

Serum total bilirubin =1.5 x ULN (biliary drainage is allowed for biliary obstruction)
2. Severe renal impairment (CLcr = 30 ml/min)
3. Inadequate bone marrow reserves as evidenced by:
a. ANC = 1,5 x 10 9 /L; or
b. Platelet count = 100 x 10 9 /L;
4. WHO/PS 2 or higher
Any clinically significant disorder impacting the risk-benefit balance negatively per physician’s judgment
6. Any clinically significant gastrointestinal disorder, including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea > grade 1
7. Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) in last 6 months
8. NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure. Or known abnormal ECG with clinically significant abnormal findings
9. Active infection or an unexplained fever >38.5°C (excluding tumor fever), which in the physician’s opinion might compromise the patient’s health
10. Current use or any use in last two weeks of strong CYP3A-enzyme inducers/inhibitors and/or strong UGT1A inhibitors
11. Known hypersensitivity to any of the components of liposomal irinotecan (Nal-IRI) other liposomal irinotecan formulations, irinotecan, fluoropyrimidines, or leucovorin.
12. Hypersensitivity to any of the active substances (tegafur, gimeracil, and oteracil)
13. Previous treatment with fluoropyrimidine therapy
14. Known dihydropyrimidine dehydrogenase (DPD) deficiency
15. 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).
16. Treatment within 4 weeks with DPD inhibitors, including sorivudine or its chemically related analogues such as brivudine.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.<br>Phase II part: Efficacy between the treatment arms in terms of progression free survival.;Secondary Objective: Overall survival<br>Response rate according to RECIST 1.1<br>Adverse events according to NCI CTC version 4.0<br>Quality of life;Primary end point(s): 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.<br>Phase II part: Efficacy between the treatment arms in terms of progression free survival.;Timepoint(s) of evaluation of this end point: Evaluation with CTscan/ MRI will take place every 2 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Overall survival<br>Response rate according to RECIST 1.1<br>Adverse events according to NCI CTC version 4.0<br>Quality of life;Timepoint(s) of evaluation of this end point: Evaluation with CTscan/ MRI will take place every 2 months<br>Adverse events will be evaluated every 2 weeks<br>Quality of life will be evaluated every 2 months

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