A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil / Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment
Trial Status: Active
The purpose of this study is to look at the efficacy and safety of Irinotecan liposome injection in combination with other approved drugs used for cancer therapy, namely 5 fluorouracil / leucovorin (5FU / LV) plus oxaliplatin compared to nab-paclitaxel + gemcitabine treatment in improving the overall survival of patients not previously treated for metastatic pancreatic cancer.
- Histological or cytologically confirmed adenocarcinoma of the pancreas that has not been previously treated in the metastatic setting.
- Initial diagnosis of metastatic disease must have occurred ≤6 weeks prior to screening.
- Subject has one or more metastatic tumours measurable by computed tomography (CT) scan (or magnetic resonance imaging (MRI), if the subject is allergic to CT contrast media) according to RECIST Version 1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Subject has adequate biological parameters as demonstrated by the following blood counts:(a) Absolute neutrophil count (ANC) ≥2000/mm3 without the use of hemopoietic growth factors within the last 7 days prior to randomisation (b) Platelet count ≥100,000/mm3 (c) Haemoglobin (Hgb) ≥9 g/dL obtained ≤14 days prior to randomisation.
- Adequate hepatic function as evidenced by: (a) Serum total bilirubin ≤1.5x ULN (biliary drainage is allowed for biliary obstruction), and (b) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5x upper limit of normal (ULN) (≤5x ULN is acceptable if liver metastases are present).
- Adequate renal function as evidenced by creatinine clearance ≥30 mL/min.
- Adequate coagulation studies (obtained ≤14 days prior to randomisation) as demonstrated by prothrombin time and partial thromboplastin time within normal limits (≤1.5xULN ).
- Prior treatment of pancreatic cancer in the metastatic setting with surgery, radiotherapy, chemotherapy or investigational therapy
- Prior treatment of pancreatic adenocarcinoma with chemotherapy in the adjuvant setting, except those where at least 12 months have elapsed since completion of the last dose and no persistent treatment-related toxicities are present.
- Subject has only localised advanced disease.
- Documented serum albumin <3 g/dL
- Known history of central nervous system (CNS) metastases.
- Clinically significant gastrointestinal disorder
- History of any second malignancy in the last 2 years
- Concurrent illnesses that would be a relative contraindication to trial participation
- Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1
- Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma
- Known low or absent dihydropyrimidine dehydrogenase (DPD) activity
University of Alabama at Birmingham Cancer Center
Mayo Clinic in Arizona
City of Hope Comprehensive Cancer Center
Translational Research In Oncology - US Inc
Contact: Zev Aryeh Wainberg
UCLA / Jonsson Comprehensive Cancer Center
Contact: Ruth Gonzalez
UC Irvine Health / Chao Family Comprehensive Cancer Center
University of Kentucky / Markey Cancer Center
Beth Israel Deaconess Medical Center
Wayne State University / Karmanos Cancer Institute
University of Minnesota / Masonic Cancer Center
Mayo Clinic in Rochester
Siteman Cancer Center at Washington University
Roswell Park Cancer Institute
Memorial Sloan Kettering Cancer Center
Contact: Alice Zervoudakis
Ohio State University Comprehensive Cancer Center
University of Oklahoma Health Sciences Center
OHSU Knight Cancer Institute
University of Pittsburgh Cancer Institute (UPCI)
Ben Taub General Hospital
M D Anderson Cancer Center
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
Contact: Sonia Lisa Creighton
Trial Phase Phase III
Trial Type Treatment
- Primary ID D-US-60010-001
- Secondary IDs NCI-2020-00207, 2018-003585-14
- Clinicaltrials.gov ID NCT04083235