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
- Conditions
- Metastatic Adenocarcinoma of the Pancreas
- Interventions
- Registration Number
- NCT04083235
- Lead Sponsor
- Ipsen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 770
- 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 lesions 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Irinotecan liposome injection + Oxaliplatin + 5-FU/LV Irinotecan Liposomal Injection Irinotecan liposome injection, oxaliplatin, 5 FU/LV, will be administered on Days 1 and 15 of each 28-day cycle (until progression or unacceptable toxicity). Irinotecan liposome injection + Oxaliplatin + 5-FU/LV 5Fluorouracil Irinotecan liposome injection, oxaliplatin, 5 FU/LV, will be administered on Days 1 and 15 of each 28-day cycle (until progression or unacceptable toxicity). Irinotecan liposome injection + Oxaliplatin + 5-FU/LV Leucovorin Irinotecan liposome injection, oxaliplatin, 5 FU/LV, will be administered on Days 1 and 15 of each 28-day cycle (until progression or unacceptable toxicity). Nab-paclitaxel + Gemcitabine Nab-paclitaxel Nab-paclitaxel and gemcitabine will be administered on Days 1, 8 and 15 of each 28-day cycle (until progression or unacceptable toxicity). Irinotecan liposome injection + Oxaliplatin + 5-FU/LV Oxaliplatin Irinotecan liposome injection, oxaliplatin, 5 FU/LV, will be administered on Days 1 and 15 of each 28-day cycle (until progression or unacceptable toxicity). Nab-paclitaxel + Gemcitabine Gemcitabine Nab-paclitaxel and gemcitabine will be administered on Days 1, 8 and 15 of each 28-day cycle (until progression or unacceptable toxicity).
- Primary Outcome Measures
Name Time Method Overall Survival (OS) Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose, end of treatment (EoT) visit, then every 2 months thereafter up to DCO date of 23 July 2022 (maximum of 893 days) The OS was defined as time from the date of randomization to the date of death due to any cause. Participants who did not have a date of death recorded at the time of the final analysis were censored at the last known time that the participant was alive. The median OS was measured using Kaplan-Meier technique.
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS) Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose until EoT visit (maximum of 893 days) PFS was defined as the time from the date of randomization to the first documented disease progression using response evaluation criteria in solid tumors (RECIST) Version 1.1 as per Investigator assessment or death due to any cause. The median PFS was measured using Kaplan-Meier technique.
Overall Response Rate (ORR) Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose until EoT visit, (maximum of 893 days) The ORR was defined as the percentage of participants with a best overall response (BOR) characterized as either a complete response (CR) or partial response (PR) per RECIST Version 1.1. BOR was defined as the best response as recorded from randomization until documented objective disease progression using RECIST Version 1.1. As per RECIST version 1.1, CR is disappearance of all target lesions; PR is \>=30% decrease in the sum of the longest diameter of target lesions; and overall response = CR + PR. The ORR was calculated using Clopper-Pearson method.
Trial Locations
- Locations (199)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Banner Health- MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
Mayo Clinic - Scottsdale
🇺🇸Phoenix, Arizona, United States
Comprehensive Blood And Cancer Center
🇺🇸Bakersfield, California, United States
University of California- Irvine Health Cancer Cente
🇺🇸Costa Mesa, California, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
University of California, Los Angeles (UCLA)
🇺🇸Los Angeles, California, United States
St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare
🇺🇸Orange, California, United States
University of California - Irvine Medical Center
🇺🇸Orange, California, United States
Torrance Memorial Physician Network Cancer Care
🇺🇸Redondo Beach, California, United States
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