A randomized phase II study of second line treatment with liposomal irinotecan and S1 versus liposomal irinotecan and 5-fluorouracil in patients with metastatic pancreatic cancer who failed on first line gemcitabine-based chemotherapy
- Conditions
- metastatic pancreatic cancer
- Registration Number
- 2023-509463-24-01
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
To determine the progression free survival (PFS) benefit of nal-IRI combined with S-1, compared with nal-IRI combined with 5-FU/LV, in subjects pre-treated with gemcitabine based chemotherapy for metastatic pancreatic ductal adenocarcinoma, or progression within 6 months of adjuvant gemcitabine treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruitment ended
- Sex
- Not specified
- Target Recruitment
- 146
Able to understand and provide written informed consent
≥ 18 years of age
Histologically or cytologically confirmed adenocarcinoma of pancreas
Documented metastatic disease, according to RECIST 1.1.
Previously treated with gemcitabine or gemcitabine containing therapy, or progression within 6 months of adjuvant gemcitabine based treatment
Adequate hepatic (serum bilirubin total between 0-17 μmol/L, AST between 0-40 U/L, ALT between 0-34 U/L, renal (creatinine between 65-95 μmol/L) and hematological (hemoglobin between 7.5-10 mmol/L, platelets between 150-400 10E9/L, leukocytes between 4.0-10.5 10E9/L) function
Serum total bilirubin ≥1.5 x ULN (biliary drainage is allowed for biliary obstruction)
Current use or any use in last two weeks of strong CYP2A6- enzyme inhibitors, 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).
or male patients: unwilling to use contraception during treatment and 4 months following last dose of Nal-IRI and 6 months after S-1
Contraception required for 6 months following the last dose of S-1
Treatment within 4 weeks with DPD inhibitors, including sorivudine or its chemically related analogues such as brivudine.
Severe renal impairment (CLcr ≤ 30 ml/min)
Inadequate bone marrow reserves as evidenced by: a. ANC ≤ 1,5 x 10 9 /L; or b. Platelet count ≤ 100 x 10 9 /L;
WHO/PS 2 or higher
Any clinically significant disorder impacting the risk-benefit balance negatively per physician’s judgment
Any clinically significant gastrointestinal disorder, including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea > grade 1
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival Progression free survival
- Secondary Outcome Measures
Name Time Method Overall survival Overall survival
Response rate according to RECIST 1.1 Response rate according to RECIST 1.1
Adverse events according to NCI CTC version 4.0 Adverse events according to NCI CTC version 4.0
Quality of life (QLQ-C30) Quality of life (QLQ-C30)
Trial Locations
- Locations (5)
Centro Ricerche Cliniche Di Verona S.r.l.
🇮🇹Verona, Italy
Amsterdam UMC Stichting
🇳🇱Amsterdam, Netherlands
Academisch Ziekenhuis Maastricht
🇳🇱Maastricht, Netherlands
Vall D Hebron Institute Of Oncology
🇪🇸Barcelona, Spain
Medical University Of Vienna
🇦🇹Vienna, Austria
Centro Ricerche Cliniche Di Verona S.r.l.🇮🇹Verona, ItalyDavide MelisiSite contact+39458121111ufficio.protocollo@aovr.veneto.it