Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study) (apact)
Pancreatic Neoplasms, Digestive System Neoplasms, Neoplasms by Site
About this trial
This is an interventional treatment trial for Pancreatic Neoplasms focused on measuring Resectable pancreatic cancer, resected, resectable PDA, adenocarcinoma, surgically resected, adjuvant, Abraxane, nab-paclitaxel, ABI-007, gemcitabine, Gemzar, Phase 3
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1). Subjects with neuroendocrine (and mixed type) tumors are excluded.
- Pancreatic cancer surgical staging: Tumor (T) 1-3, Lymph Node (LN) N0-1, Metastasis (M) 0.
- Subject should be able to start treatment no later than 12 weeks postsurgery.
- ≥18 years of age at the time of signing the informed consent form (ICF).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Acceptable hematology parameters:
- Absolute neutrophil count (ANC) ≥1500 cell/mm^3
- Platelet count ≥100,000/mm^3
- Hemoglobin (Hgb) ≥9 g/dL
Acceptable blood chemistry levels:
- Aspartate aminotransferase (AST)/ serum glutamic oxaloacetic transaminase (SGOT) and alanine transaminase (ALT)/ serum glutamic -pyruvic transaminase (SGPT) ≤2.5 × upper limit of normal range (ULN)
- Total bilirubin ≤ upper limit of normal (participants with Gilbert's syndrome can have bilirubin of up to 1.5 x ULN)
- Alkaline phosphatase ≤ 2.5 x ULN
- Serum creatinine within upper limits of normal or calculated clearance ≥50 mL/min/1.73 m^2. If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (eg, using the Cockroft-Gault formula). For subjects with a body mass index (BMI) >30 kg/m2, lean body weight should be used instead
- Cancer antigen (CA)19-9 <100 U/mL assessed within 14 days of randomization
- Acceptable coagulation studies as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits (±15%)
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma
- Presence of or history of metastatic pancreatic adenocarcinoma
- Any other malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, or nonmelanomatous skin cancer (all treatment of which should have been completed 6 months prior to randomization)
- Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment
- Known infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or subject receiving immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications
- History of allergy or hypersensitivity to nab-paclitaxel or gemcitabine or any of their excipients
Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the subject's safety or the study data integrity. These include, but are not limited to:
- History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa)
- History of interstitial lung disease, slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies
- History of the following within 6 months prior to Cycle 1 Day 1: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or electrocardiogram (ECG) abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder
Sites / Locations
- Local Institution - 043
- Mayo Clinic - Arizona
- UCSD Moores Cancer Center
- University of Southern California
- Local Institution - 044
- UC Davis Cancer Center
- Local Institution - 001
- University of California, San Francisco Cutaneous Oncology and Melanoma Center
- University of California Los Angeles
- University of Colorado Cancer Center
- Local Institution - 059
- Rocky Mountain Cancer Centers, LLP [Denver-Midtown]
- Yale Cancer Center
- Local Institution - 022
- Lynn Cancer Institute
- Florida Cancer Institute Cancer Spec
- Local Institution - 031
- Gainesville Heme Oncology Associates
- Local Institution - 011
- University of Florida
- University of Miami and Sylvester Cancer Center
- Florida Hospital Cancer Institute
- Local Institution - 039
- H Lee Moffitt Cancer Center
- Georgia Cancer Specialist
- University of Chicago Medical Center
- Northshore University Healthsystem Research Institute
- Illinois Cancer Specialists
- University of Louisville
- Ochsner Clinic Foundation
- Ochsner Medical Center - Jefferson Highway
- Massachusetts General Hospital
- Beth Israel-Deaconess Medical Center
- Local Institution - 040
- Dana Farber Cancer Institute
- Local Institution - 045
- Local Institution - 036
- University of Michigan
- Karmanos Cancer Center Wayne State University
- Local Institution - 021
- Mayo Clinic
- Local Institution - 048
- Nebraska Methodist Hospital
- Local Institution - 064
- MSKCC Basking Ridge
- Saint Barnabas Medical Center
- Local Institution - 025
- Roswell Park Cancer Institute
- Memorial Sloan-Kettering Cancer Center
- Memorial Sloan Kettering Cancer Center West Harrison
- NYU Langone Medical Center
- Local Institution - 008
- Memorial Sloan-Kettering Cancer Center - NYC
- Columbia University Medical Center
- Local Institution - 032
- Local Institution - 013
- University of Rochester Cancer Center, James P. Wilmot Cancer Center
- Local Institution - 066
- MSKCC at Mercy Medical Center Mercy RockvilleCenter
- MSKCC at Phelps Memorial Hospital Center. Phelps Sleepy Hollow
- State University of New York Upstate Medical Center
- Local Institution - 051
- Wake Forest Univ. Health Sciences Outpatient Comprehensive Cancer Center
- Local Institution - 030
- Oncology Hematology Care, Inc.
- University of Cincinnati Medical CenterDivsion of Hematology OncologyThe Barrett Center
- Case Western Reserve Center
- Local Institution - 047
- Cleveland Clinic - Taussig Cancer Institute
- Cleveland Clinic Foundation IRB
- Cleveland Clinic Foundation
- Local Institution - 020
- Local Institution - 054
- Local Institution - 005
- Ohio State University Medical Center
- Local Institution - 049
- University of Oklahoma Peggy and Charles Stephenson Cancer Center
- Local Institution - 019
- Oregon Health and Science University OHSU
- Local Institution - 016
- Thomas Jefferson University
- Fox Chase Cancer Center
- Local Institution - 027
- UPMC Cancer Pavillion
- Chattanooga Oncology Hematology Care
- Local Institution - 023
- Local Institution - 004
- Sarah Cannon Research Inst
- Local Institution - 002
- Vanderbilt- Ingram Cancer Center
- Texas Oncology
- Baylor Sammons Cancer Center
- Local Institution - 062
- Local Institution - 010
- UT Southwestern Medical Center
- Local Institution - 050
- The Center for Cancer and Blood Disorders - Fort Worth
- Baylor College of Medicine
- Local Institution - 041
- Texas Oncology, P.A. - Tyler
- Local Institution - 038
- University of Virginia
- Local Institution - 003
- Seattle Cancer Care Alliance - Seattle
- Virginia Mason Cancer Center
- Local Institution - 014
- University of Wisconsin - Madison Cancer Center
- Canberra Hospital
- Local Institution - 505
- Local Institution - 501
- Local Institution - 507
- Northern Cancer Institute
- Local Institution - 504
- ICON Cancer Center
- Local Institution - 502
- Local Institution - 506
- Local Institution - 508
- St John of God Subiaco Hospital
- Monash Medical Centre Moorabbin Campus
- Saint Vincent's Hospital
- Austin Hospital
- Local Institution - 509
- Royal Brisbane and Women's Hospital
- Cabrini Hospital
- Local Institution - 503
- Local Institution - 500
- Prince of Wales Hospital
- The Queen Elizabeth Hospital
- Local Institution - 205
- Medical University of Graz
- Local Institution - 203
- Medical University Innsbruck
- Hospital of Elisabethinen Linz
- Local Institution - 206
- Local Institution - 204
- Salzburger Landkliniken St. Johanns-Spital
- Klinikum Wels-Grieskirchen GmbH
- Local Institution - 0207
- Hospital Wiener Neustadt
- Local Institution - 202
- Local Institution - 200
- Medizinische Universitat Wien
- Kaiser-Franz-Josef Spital
- Local Institution - 201
- Hopital Erasme
- Local Institution - 211
- UZ Antwerpen
- Local Institution - 213
- UZ Gent
- Local Institution - 210
- UZ Leuven
- Local Institution - 102
- Tom Baker Cancer Center
- Local Institution - 101
- Sunnybrook Health Sciences Centre
- Local Institution - 100
- Princess Margaret Hospital
- Centre Hospitalier de L'Universite de Montreal St-Luc
- Local Institution - 104
- Jewish General Hospital
- Local Institution - 103
- Fakultni nemocnice Hradec Kralove
- Local Institution - 220
- Krajska nemocnice Liberec, a.s.
- Krajska nemocnice T. Bati a.s.
- Local Institution - 221
- Hæmatologisk afd. B Aalborg Sygehus Syd
- Local Institution - 231
- Herlev Hospital
- Local Institution - 232
- Local Institution - 230
- Onk.Dep., Odense Universitets hospital
- Local Institution - 240
- Helsingin yliopistollinen keskussairaala
- Local Institution - 241
- Tampereen yliopistollinen sairaala
- Local Institution - 242
- Turku University Hospital
- Center Hospitalier Universitaire d' Angers
- Local Institution - 253
- Hopital Henri Mondor
- CHRU de Lille France
- Local Institution - 257
- Hopital Edouard Herriot - Hepato-gastroenterologie
- Local Institution - 258
- Hopital prive Jean Mermoz
- Local Institution - 252
- Hopital Europeen Georges Pompidou
- Local Institution - 250
- Hopital Saint Antoine
- Hopital Pitie Salpetriere
- Local Institution - 259
- CHU La Miletrie
- Local Institution - 251
- Local Institution - 256
- Pole Des Specialites Medicales, Hopital Purpan
- Klinikum Weiden
- Local Institution - 280
- Charite - Universitätsmedizin Berlin
- Local Institution - 272
- Local Institution - 278
- Universitatsklinikum Carl Gustav Carus an der TU Dresden
- Kliniken Essen-Mitte
- Local Institution - 277
- Universitatsklinkum Frankfurt
- Local Institution - 284
- Praxis Internistischer Onkologie und Hamatologie Frechen
- Local Institution - 275
- Praxis für Innere Medizin, Dr.Oettle Helmut
- Ernst-Moritz-Arndt-Universität Greifswald
- Local Institution - 279
- Local Institution - 273
- Universitaetsklinik Hamburg - Eppendorf
- Local Institution - 281
- Praxis Internistischer Onkologie und Hamatologie Koln
- Local Institution - 274
- Universitatsklinik Magdeburg
- Klinikum der Johannes Gutenberg Uniervsitaet ,Haematologie
- Local Institution - 283
- Klinikum der Universitat Munchen-Grosshadern
- Local Institution - 282
- Klinikum Neuperlach
- Local Institution - 276
- Local Institution - 0271
- University of Tubingen
- Local Institution - 270
- Universitatsklinikum Würzburg
- Local Institution - 601
- Queen Mary Hospital
- Tuen Mun Hospital
- Local Institution - 602
- Prince of Wales Hospital the Chinese University of Hong Kong
- Fovarosi Szent Istvan es Szent Laszlo Korhaz es Rendelointezet
- Local Institution - 293
- Local Institution - 291
- Uzsoki Utcai Korhaz
- Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
- Local Institution - 290
- Local Institution - 292
- Petz Aladar Megyei Oktato Korhaz,II. Belgyogyaszat
- Local Institution - 295
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szent-Gyorgyi Albert TE AOK Borgyogy
- Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
- Local Institution - 311
- Cork University Hospital
- Local Institution - 310
- St Vincent's University Hospital
- Local Institution - 329
- Local Institution - 325
- Ospedali Riuniti Umberto I GM Lancisi
- Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
- Local Institution - 330
- Azienda Ospedaliero-Universitaria Careggi
- Local Institution - 328
- Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)
- Local Institution - 331
- Local Institution - 321
- Ospedale San Raffaele S.r.l.
- Azienda Ospedaliera Niguarda Ca Granda
- Local Institution - 322
- Azienda Ospedaliero-Universitaria Pisana
- Local Institution - 324
- Arcispedale Santa Maria Nuova
- Local Institution - 333
- Local Institution - 323
- Local Institution - 327
- Policlinico Universitario Agostino Gemelli
- Istituto Nazionale Tumori Regina Elena
- Istituto Clinico Humanitas
- Local Institution - 326
- IRCCS Casa Sollievo della Sofferenza
- Local Institution - 332
- Azienda Ospedaliera S Maria di Terni
- Azienda Ospedaliera Universitaria Integrata di Verona
- Local Institution - 320
- Local Institution - 641
- Seoul National University Hospital
- Local Institution - 642
- Samsung Medical Center
- Asan Medical Center
- Local Institution - 640
- Academisch Medisch Centrum Amsterdam
- Local Institution - 400
- Catharina Hospital
- Local Institution - 403
- Isala Klinieken
- Local Institution - 402
- Centro Hospitalar de Lisboa Central - Hospital de Santo António dos Capuchos
- Local Institution - 340
- Hospital Da Luz
- Local Institution - 341
- Hospital de Sao Joao
- Local Institution - 342
- Local Institution - 610
- National University Hospital
- Local Institution - 611
- National Cancer Center
- Local Institution - 371
- Local Institution - 360
- Clinic Barcelona Hospital Universitari
- Local Institution - 363
- Instituto Catalan de Oncologia-Hospital Duran
- Local Institution - 370
- Hospital Universitari Vall d'Hebron
- Hospital General Gregorio Maranon
- Local Institution - 367
- Local Institution - 362
- Ramon y Cajal Univeresity Hospital
- Hospital Clinico San Carlos
- Local Institution - 372
- Hospital 12 de Octubre
- Local Institution - 365
- Centro Integral
- Local Institution - 361
- Hospital General Carlos Haya
- Local Institution - 369
- Complejo Hospitalario de Navarra
- Local Institution - 368
- Hospital Universitario Marques de Valdecilla
- Hospital Clinico Universitario De Santiago De Compostela
- Local Institution - 366
- Hospital Virgen del Rocio
- Local Institution - 364
- Local Institution - 620
- Taichung Veterans General Hospital
- Local Institution - 625
- National Cheng Kung University Hospital
- Local Institution - 623
- Taipei Veterans General Hospital
- Tri-Service General Hospital
- Local Institution - 622
- Chang Gung Medical Foundation-Linkou Branch
- Local Institution - 624
- Local Institution - 621
- National Taiwan University Hospital
- Addenbrookes Hospital
- Local Institution - 382
- Glasgow Royal Infirmary
- Local Institution - 380
- Weston Park Hospital
- Local Institution - 381
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
nab-Paclitaxel 125 mg/m^2 plus gemcitabine 1000 mg/m2
Gemcitabine 1000 mg/m^2
Participants received nab-Paclitaxel 125 mg/m^2 administered as an intravenous (IV) infusion over 30 to 40 minutes, followed by gemcitabine 1000 mg/m^2 as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.
Participants received gemcitabine 1000 mg/m^2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.