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)
Oncology Consultants
🇺🇸Houston, Texas, United States
Miami Cancer Institute
🇺🇸Miami, Florida, United States
University of Oklahoma - Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Mayo Clinic - Scottsdale
🇺🇸Phoenix, Arizona, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Kaiser Permanente - Northwest
🇺🇸Portland, Oregon, United States
Mayo Clinic - Rochester
🇺🇸Rochester, Minnesota, United States
Instituto Nacional Do Cancer (INCA)
🇧🇷Rio de Janeiro, Brazil
Alberta Health Services Cross Cancer Institute
🇨🇦Edmonton, Canada
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
🇺🇸Omaha, Nebraska, United States
Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Florida Cancer Specialists - Fort Myers
🇺🇸Sarasota, Florida, United States
Florida Cancer Specialists - Panhandle
🇺🇸Tallahassee, Florida, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Edward Hospital - Elmhurst
🇺🇸Elmhurst, Illinois, United States
Florida Cancer Specialists - East
🇺🇸West Palm Beach, Florida, United States
Illinois CancerCare - Peoria
🇺🇸Peoria, Illinois, United States
Carle Cancer Center
🇺🇸Urbana, Illinois, United States
University of Kentucky Markey Cancer Center
🇺🇸Lexington, Kentucky, United States
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
The West Cancer Center
🇺🇸Memphis, Tennessee, United States
Houston Methodist Research Institute
🇺🇸Houston, Texas, United States
Texas Oncology - Tyler
🇺🇸Tyler, Texas, United States
Virginia Cancer Specialists
🇺🇸Fairfax, Virginia, United States
Froedtert Hospital and the Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Australia
Centre Antoine-Lacassagne
🇫🇷Nice, France
Hopital Saint Louis
🇫🇷Paris, France
Centre Hospitalier Universitaire de Poitiers - Poitiers University Hospital
🇫🇷Poitiers Cedex, France
Strasbourg Oncologie Liberale
🇫🇷Strasbourg, France
Slk-Kliniken
🇩🇪Heilbronn, Germany
Agios Savvas Anticancer Hospital
🇬🇷Athens, Greece
Dél-pesti Centrumkórház - Szent László Kórház telephely
🇭🇺Budapest, Hungary
Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika
🇭🇺Budapest, Hungary
CHA Bundang Medical Center
🇰🇷Gyeonggi-do, Korea, Republic of
Seoul St. Mary's Hospital, The Catholic University of Korea
🇰🇷Seoul, Korea, Republic of
Champalimaud Cancer Center
🇵🇹Lisbon, Portugal
Hospital General Universitario de Elche
🇪🇸Alicante, Spain
Hospital Universitario de Badajoz
🇪🇸Badajoz, Spain
Hospital Germans Trias i Pujol
🇪🇸Badalona, Spain
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Spain
Sarah Cannon and HCA Research Institute
🇺🇸Nashville, Tennessee, United States
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Florida Cancer Specialists - St. Petersburg
🇺🇸Tampa, Florida, United States
Toledo Clinic Cancer Center
🇺🇸Toledo, Ohio, United States
Fort Wayne Medical Oncology and Hematology
🇺🇸Fort Wayne, Indiana, United States
The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James)
🇺🇸Columbus, Ohio, United States
Banner Health- MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
University of California- Irvine Health Cancer Cente
🇺🇸Costa Mesa, California, United States
Comprehensive Blood And Cancer Center
🇺🇸Bakersfield, California, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
University of California - Irvine Medical Center
🇺🇸Orange, California, United States
St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare
🇺🇸Orange, California, United States
University of California, Los Angeles (UCLA)
🇺🇸Los Angeles, California, United States
Torrance Memorial Physician Network Cancer Care
🇺🇸Redondo Beach, California, United States
Sutter Health Sacramento
🇺🇸Sacramento, California, United States
Presbyterian Intercommunity Hospital (PIH)
🇺🇸Whittier, California, United States
UC Health Memorial Hospital
🇺🇸Colorado Springs, Colorado, United States
Mount Sinai Medical Center of Florida, Inc.
🇺🇸Miami Beach, Florida, United States
Rocky Mountain Cancer Center
🇺🇸Denver, Colorado, United States
Pikeville Medical Center
🇺🇸Pikeville, Kentucky, United States
Siouxland Hematology - Oncology Associates, LLP
🇺🇸Sioux City, Iowa, United States
Hematology Oncology Clinic
🇺🇸Baton Rouge, Louisiana, United States
Willis-Knighton Cancer Center
🇺🇸Shreveport, Louisiana, United States
Maine Center for Cancer Medicine
🇺🇸Scarborough, Maine, United States
Beth Israel Deaconess
🇺🇸Boston, Massachusetts, United States
Maryland Oncology Hematology
🇺🇸Silver Spring, Maryland, United States
Cancer and Hematology Centers of Western Michigan
🇺🇸Grand Rapids, Michigan, United States
Health Partners Institute
🇺🇸Minneapolis, Minnesota, United States
Frontier Cancer Center
🇺🇸Billings, Montana, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Clinical Research Alliance, Inc
🇺🇸Lake Success, New York, United States
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
University of Rochester
🇺🇸Rochester, New York, United States
Messino Cancer Center
🇺🇸Asheville, North Carolina, United States
Oncology Associates of Oregon
🇺🇸Eugene, Oregon, United States
Compass Oncology - Rose Quarter Cancer Center
🇺🇸Portland, Oregon, United States
Greenville Hospital System
🇺🇸Greenville, South Carolina, United States
Oregon Health & Science University (OHSU)
🇺🇸Portland, Oregon, United States
Chattanooga Oncology Hematology Care - Tennessee Oncology
🇺🇸Chattanooga, Tennessee, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Texas Oncology - Wichita Falls
🇺🇸Wichita Falls, Texas, United States
Utah Cancer Specialists
🇺🇸Salt Lake City, Utah, United States
Blue Ridge Cancer Care
🇺🇸Wytheville, Virginia, United States
Bankstown-Lidcombe Hospital
🇦🇺Bankstown, Australia
Medizinische Universitaet Graz
🇦🇹Graz, Austria
Monash Medical Centre
🇦🇺Clayton, Australia
St John of God Subiaco Hospital
🇦🇺Subiaco, Australia
Ordensklinikum Linz GmbH Barmherzige Schwestern
🇦🇹Linz, Austria
Queen Elizabeth Hospital
🇦🇺Woodville South, Australia
SCRI-CCCIT Gemeinnutzige Gmbh- Gemeinnutzige Salzburger Landeskliniken Betriebsgesmbh
🇦🇹Salzburg, Austria
Medical University of Vienna
🇦🇹Vienna, Austria
Onze-Lieve-Vrouwziekenhuis
🇧🇪Aalst, Belgium
ASBL Grand Hôpital de Charleroi (GHdC), Site Notre Dame
🇧🇪Charleroi, Belgium
Universitair Ziekenhuis Antwerpen (UZA)
🇧🇪Edegem, Belgium
Hospital centre Jolimont
🇧🇪Haine-Saint-Paul, Belgium
University Hospital (UZ) Leuven
🇧🇪Leuven, Belgium
University Hospital Gent
🇧🇪Gent, Belgium
University Hospital Mont-Godinne
🇧🇪Yvoir, Belgium
Fundação Pio XII - Hospital de Câncer de Barretos
🇧🇷Barretos, Brazil
Centro Regional Integrado de Oncologia (CRIO)
🇧🇷Ceara, Brazil
Centro de Pesquisas Oncológicas - CEPON
🇧🇷Florianópolis, Brazil
Hospital de Caridade de Ijui
🇧🇷Ijuí, Brazil
Instituto de Oncologia do Parana - IOP
🇧🇷Curitiba, Brazil
Clinica Neoplasias Litoral
🇧🇷Itajaí, Brazil
Centro de Pesquisas Clinicas de Natal - CPCLIN
🇧🇷Natal, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
🇧🇷Porto Alegre, Brazil
Hospital Bruno Born
🇧🇷Lajeado, Brazil
CIP Centro Integrado de Pesquisas do Hospital de Base
🇧🇷São José Do Rio Preto, Brazil
Instituto do Cancer do Estado de São Paulo (ICESP)
🇧🇷São Paulo, Brazil
Centre Hospitalier Universitaire de Sherbrooke
🇨🇦Sherbrooke, Canada
McGill University Faculty of Medicine - Royal Victoria Hospital
🇨🇦Montréal, Canada
Hôpital Edouard Herriot
🇫🇷Lyon, France
Masarykuv onkologicky ustav
🇨🇿Brno, Czechia
University Hospital Olomouc, Department of Oncology
🇨🇿Olomouc, Czechia
Fakultni nemocnice Hradec Kralove
🇨🇿Hradec Králové, Czechia
CHRU de Tours - Hôpital Trousseau
🇫🇷Chambray-lès-Tours, France
Thomayerova Nemocnice
🇨🇿Praha, Czechia
Centre Oscar Lambret
🇫🇷Lille, France
Theagenion Hospital
🇬🇷Thessaloníki, Greece
Centre Leon Berard
🇫🇷Lyon, France
Hopital Prive Jean Mermoz
🇫🇷Lyon, France
Facharztzentrum Eppendorf
🇩🇪Hamburg, Germany
CHU Bordeaux - Hopital Haut-Leveque
🇫🇷Pessac, France
Charité - Universitaetsmedizin Berlin
🇩🇪Berlin, Germany
St. Josef-Hospital
🇩🇪Bochum, Germany
Klinikum Esslingen GmbH
🇩🇪Esslingen, Germany
Studiengesellschaft BSF
🇩🇪Halle, Germany
Krankenhaus Nordwest
🇩🇪Frankfurt, Germany
Martin Luther Universitat Halle-Wittenberg
🇩🇪Halle, Germany
Asklepios Klinik Altona
🇩🇪Hamburg, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Marienkrankenhaus Hamburg
🇩🇪Hamburg, Germany
Krankenhaus St. Franziskus - Kliniken Maria Hilf GmbH
🇩🇪Mönchengladbach, Germany
General Hospital of Athens - Laiko
🇬🇷Athens, Greece
Universitaetsklinikum Ulm
🇩🇪Ulm, Germany
National and Kapodistrian University of Athens
🇬🇷Athens, Greece
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Germany
University General Hospital of Ioannina
🇬🇷Ioánnina, Greece
Országos Onkológiai Intézet
🇭🇺Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont
🇭🇺Debrecen, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz
🇭🇺Kaposvár, Hungary
Rambam Health Care Campus
🇮🇱Haifa, Israel
Soroka Medical Center
🇮🇱Beer Sheva, Israel
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelointézet
🇭🇺Szolnok, Hungary
Policlinico S. Orsola-Malpighi
🇮🇹Bologna, Italy
AUSL di Piacenza-Ospedale Guglielmo Da Saliceto
🇮🇹Piacenza, Italy
Istituto Europeo di Oncologia
🇮🇹Milano, Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
🇮🇹Meldola, Italy
Azienda Ospedaliero-Universitaria di Modena
🇮🇹Modena, Italy
Azienda Ospedaliero Universitaria Pisana
🇮🇹Pisa, Italy
Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma
🇮🇹Verona, Italy
AOU Ospedali Riuniti di Ancona
🇮🇹Torrette, Italy
Inje University Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
Hospital de Braga
🇵🇹Braga, Portugal
National Cancer Center
🇰🇷Goyang-si, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Centro Hospitalar Universitario de Lisboa Norte - Hospital de Santa Maria
🇵🇹Lisboa, Portugal
Unidade Local de Saude Matosinhos E.P.E. Hospital Pedro Hispano
🇵🇹Senhora da Hora, Portugal
Centro Hospitalar de Vila Nova de Gaia/Espinho EPE
🇵🇹Vila Nova de Gaia, Portugal
Kursk Regional Clinical Oncology Dispensary
🇷🇺Kursk, Russian Federation
Evimed LLC
🇷🇺Chelyabinsk, Russian Federation
Main Military Clinical Hospital named after N.N. Burdenko
🇷🇺Moscow, Russian Federation
Hospital Quironsalud Barcelona
🇪🇸Barcelona, Spain
Federal State Budgetary Institution - Russian Scientific Center of Radiology and Surgical Technologies n.a. academician A.M.Granov
🇷🇺Saint-Petersburg, Russian Federation
Hospital de la Santa Creu i Sant Pau Barcelona
🇪🇸Barcelona, Spain
Volga District Medical Centre
🇷🇺Novgorod, Russian Federation
Corporacio Sanitaria Parc Tauli - Hospital de Sabadell
🇪🇸Barcelona, Spain
Hospital Clinic Barcelona
🇪🇸Barcelona, Spain
Hospital Vall D Hebron
🇪🇸Barcelona, Spain
Institut Catala d'Oncologia - L'Hospitalet
🇪🇸Barcelona, Spain
Complejo Hospitalario de Navarra
🇪🇸Pamplona, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Regional Universitario de Malaga
🇪🇸Málaga, Spain
Centro Integral Oncologico Clara Campal
🇪🇸Madrid, Spain
Guy's and St. Thomas' NHS Foundation Trust
🇬🇧London, United Kingdom
Royal Marsden Foundation Trust
🇬🇧London, United Kingdom
Hospital Universitario Marques de Valdecilla
🇪🇸Santander, Spain
Imperial College Healthcare NHS Trust
🇬🇧London, United Kingdom
Cancer Research UK - Christie Hospital Foundation NHS Trust - Dept of Medical Oncology
🇬🇧Manchester, United Kingdom
Nottingham City Hospital
🇬🇧Nottingham, United Kingdom
Fiona Stanley Hospital
🇦🇺Murdoch, Australia
The Center for Cancer and Blood Disorders
🇺🇸Fort Worth, Texas, United States
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Instituto COI
🇧🇷Rio De Janeiro, Brazil
Hospital Alemão Oswaldo Cruz
🇧🇷São Paulo, Brazil
Instituto Brasileiro de Controle do Cancer - IBCC (Sao Paulo)
🇧🇷San Paolo, Brazil
Klinikum Mannheim
🇩🇪Mannheim, Germany
Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves
🇪🇸Granada, Spain
Limited Liability Company- Clinica Druzhkovyh
🇷🇺Kazan, Russian Federation
Research Medical Center
🇺🇸Kansas City, Missouri, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Texas Oncology - Austin
🇺🇸Austin, Texas, United States
Queen Elizabeth II Health Sciences Centre
🇨🇦Halifax, Canada