Phase III Study of ABI-007(Albumin-bound Paclitaxel) Plus Gemcitabine Versus Gemcitabine in Metastatic Adenocarcinoma of the Pancreas
A Randomized Phase III Study of Weekly ABI-007 Plus Gemcitabine Versus Gemcitabine Alone in Patients With Metastatic Adenocarcinoma of the Pancreas
1 other identifier
interventional
861
10 countries
172
Brief Summary
Phase III Metastatic Pancreatic Cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2009
Typical duration for phase_3
172 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2009
CompletedFirst Posted
Study publicly available on registry
February 16, 2009
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 17, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 9, 2013
CompletedResults Posted
Study results publicly available
December 11, 2013
CompletedNovember 25, 2019
November 1, 2019
3.6 years
February 13, 2009
October 21, 2013
November 7, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
Overall survival was defined as the time from the date of randomization to the date of death from all causes. Participants who did not die were censored at the last known time the participant was alive. Patient survival was summarized using Kaplan-Meier methods.
From randomization to death; until the data cut off 17 Sept 2012. The maximum time in follow up was 37 months.
Secondary Outcomes (2)
Progression-free Survival (PFS) by Independent Radiological Review (IRR)
Randomization until disease progression or death from any cause; Until the data cut off of 17 Sept 2012. The maximum time in follow up was 37 months.
Percentage of Participants Who Achieved an Objective Confirmed Overall Response by Independent Radiological Review (IRR)
Assessment every 4 weeks after initial response; Day 1 to data cut off of 17 Sept 2013; maximum time on study 37 months
Other Outcomes (4)
Participants With Treatment Emergent Adverse Events (AE)
Study drug initiation through 30 days after the last dose of study drug or EOS, whichever is later; Up to 696 days
Number of Participants With Dose Reductions
Maximum time on treatment was 666 days
Number of Participants With Dose Interruptions
Maximum time on treatment was 666 days
- +1 more other outcomes
Study Arms (2)
Albumin-bound paclitaxel (ABI-007)/Gemcitabine
EXPERIMENTALABI-007 125 mg/m2 administered in combination with gemcitabine 1000 mg/m2 weekly for 3 weeks followed by one week of rest.
Gemcitabine
ACTIVE COMPARATORGemcitabine, 1000 mg/m2 administered weekly for 7 weeks followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks followed by a week of rest (Cycle 2 onward).
Interventions
ABI-007 125 mg/m\^2 administered by intravenous infusion
Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks, Day 1 through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks, Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward).
Eligibility Criteria
You may qualify if:
- Participant has definitive histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. The definitive diagnosis of metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the clinical and radiographic data. Participants with islet cell neoplasms are excluded.
- Initial diagnosis of metastatic disease must have occurred ≤6 weeks prior to randomization in the study.
- Patient has one or more metastatic tumors measurable by Computed Tomography (CT) scan or Magnetic resonance imaging (MRI), if patient is allergic to CT contrast media).
- Male or non-pregnant and non-lactating female, and ≥ 18 years of age. If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test Beta-Human Chorionic Gonadotropin (β-hCG) documented 72 hours prior to the first administration of study drug.
- If sexually active, the patient must agree to use contraception considered adequate and appropriate by the Investigator during the period of administration of study drug. In addition, male and female patients must utilize contraception after the end of treatment as recommended in the product's Summary of Product Characteristics or Prescribing Information provided in the study manual.
- Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatment with 5-Fluorouracil (5-FU) or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present. Patients having received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting are not eligible for this study.
- Patient has adequate biological parameters as demonstrated by the following blood counts at Baseline (obtained ≤14 days prior to randomization):
- Absolute neutrophil count (ANC) ≥ 1.5 Ă— 10\^9/L; Platelet count ≥ 100,000/mm\^3 (100 Ă— 10\^9/L); Hemoglobin (Hgb) ≥ 9 g/dL.
- Patient has the following blood chemistry levels at Baseline (obtained ≤14 days prior to randomization):
- Aspartate Transaminase (AST), Serum Glutamic-Oxaloacetic Transaminase (SGOT), Alanine Transaminase ( ALT) Serum Glutamic-Pyruvic Transaminase (SGPT) ≤ 2.5 Ă— upper limit of normal range (ULN), unless liver metastases are clearly present, then ≤ 5 Ă— ULN is allowed Total bilirubin ≤ ULN Serum creatinine within normal limits or calculated clearance ≥ 60 mL/min/1.73 m\^2 for patients with serum creatinine levels above or below the institutional normal value. If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (e.g., using the Cockroft-Gault formula). For patients with a Body Mass Index (BMI) \>30 kg/m\^2, lean body weight should be used instead.
- Patient has acceptable coagulation studies (obtained ≤14 days prior to randomization) as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits (± 15%).
- Patient has no clinically significant abnormalities in urinalysis results (obtained ≤14 days prior to randomization).
- Patient has a Karnofsky performance status (KPS) ≥ 70. Two observers will be required to assess KPS. If discrepant, the one with the lowest assessment will be considered true.
- Patients should be asymptomatic for jaundice prior to Day 1. Significant or symptomatic amounts of ascites should be drained prior to Day 1. Pain symptoms should be stable and should not require modifications in analgesic management prior to Day 1.
- Patient has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form (ICF) prior to participation in any study-related activities.
You may not qualify if:
- Patient has known brain metastases, unless previously treated and well-controlled for at least 3 months (defined as clinically stable, no edema, no steroids and stable in 2 scans at least 4 weeks apart).
- Patient has only locally advanced disease.
- Patient has experienced a ≥10% decrease in KPS between baseline visit and within 72 hours prior to randomization.
- Patient has a ≥20% decrease in serum albumin level between baseline visit and within 72 hours prior to randomization.
- History of malignancy in the last 5 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years.
- Patient uses Coumadin.
- Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
- Patient has known historical or active infection with Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C.
- Patient has undergone major surgery, other than diagnostic surgery (i.e.--surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.
- Patient has a history of allergy or hypersensitivity to any of the study drugs or any of their excipients, or the patient exhibits any of the events outlined in the Contraindications or Special Warnings and Precautions sections of the product or comparator Summary of Product Characteristics (SmPC) or Prescribing Information.
- History of connective tissue disorders (e.g., lupus, scleroderma, arteritis nodosa).
- Patients with a history of interstitial lung disease.
- History of chronic leukemias (e.g., chronic lymphocytic leukemia).
- Patients with high cardiovascular risk, including, but not limited to, recent coronary stenting or myocardial infarction in the past year.
- History of Peripheral Artery Disease (e.g,. claudication, Leo Buerger's disease).
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (193)
UAB Comprenhensive Cancer Center at University of Alabama
Birmingham, Alabama, 35294, United States
Clearview Cancer Institute Oncology Specialities, P.C.
Huntsville, Alabama, 35805, United States
TGEN Clinical Research Services at Scottsdale Healthcare
Scottsdale, Arizona, 85258, United States
Mayo Clinic-Scottsdale
Scottsdale, Arizona, 85259, United States
Northern Arizona Hematology and Oncology Associates-AOA
Sedona, Arizona, 86336, United States
Arizona Cancer Center, University of Arizona
Tucson, Arizona, 85724, United States
Genesis Cancer Center
Hot Springs, Arkansas, 71913, United States
Tower Cancer Research Foundation
Beverly Hills, California, 90211, United States
City of Hope
Duarte, California, 91010, United States
Pacific Shores Medical Group
Long Beach, California, 90813, United States
UCLA
Los Angeles, California, 90024, United States
Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage, California, 92270, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
Rocky Mountain Cancer Center
Denver, Colorado, 80218, United States
University Cancer Institute, LLC
Boynton Beach, Florida, 33426, United States
Collaborative Research Group
Boynton Beach, Florida, 33435, United States
FL Cancer Specialist
Fort Myers, Florida, 33916, United States
Lakeland Regional Cancer Center
Lakeland, Florida, 33805, United States
Ocala Oncology Center
Ocala, Florida, 34471, United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804, United States
Lake County Oncology and Hematology
Tavares, Florida, 32778, United States
Phoebe Putney Cancer Center
Albany, Georgia, 31701, United States
Northeast Georgia Cancer Care, LLC
Athens, Georgia, 30607, United States
Piedmont Hospital Research Institute
Atlanta, Georgia, 30309, United States
Georgia Cancer Specialists
Atlanta, Georgia, 30341, United States
Atlanta Cancer Care
Atlanta, Georgia, 30342, United States
Cancer Care & Hemaotology Specialists of Chicagoland
Arlington Heights, Illinois, 60005, United States
NorthShore University HealthSystem
Evanston, Illinois, 60021, United States
Cancer Care & Hematology Specialists of Chicagoland
Niles, Illinois, 60714, United States
Illinois Cancer Care
Peoria, Illinois, 61615, United States
Orchard Research
Skokie, Illinois, 60076, United States
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Hutchinson Clinic, PA
Hutchinson, Kansas, 67502, United States
Owsley Brown Frazier Cancer Center
Louisville, Kentucky, 40245, United States
Hematology Oncology Clinic
Baton Rouge, Louisiana, 70809, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
Central Maine Medical Center
Lewiston, Maine, 04240, United States
Mercy Hospital Portland, ME
Portland, Maine, 04102, United States
Maine Center for Cancer Medicine
Scarborough, Maine, 04074, United States
Sidney Kimmel Comphrensive Cancer Center, John Hopkins University
Baltimore, Maryland, 21231, United States
Center for Cancer & Blood Disorders
Bethesda, Maryland, 20817, United States
Lahey Clinic
Burlington, Massachusetts, 01805, United States
Cancer Center of Excellence/University of MA Medical School
Worcester, Massachusetts, 01655, United States
St. Mary's/ Duluth Clinic
Duluth, Minnesota, 55805, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55408, United States
University of Minnesota, Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
St. John's Medical Research Institute
Springfield, Missouri, 65807, United States
Saint Louis University
St Louis, Missouri, 63110, United States
The Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, 08003, United States
Hem Onc Associates-NM
Albuquerque, New Mexico, 87106, United States
University of New Mexico
Albuquerque, New Mexico, 87131-0001, United States
New York Oncology Hematology PC
Albany, New York, 12206, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Arena Oncology Associates, PC
Lake Success, New York, 11042, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Piedmont Hematology Oncology
Winston-Salem, North Carolina, 27103, United States
Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
Mid Ohio Oncology/Hematology Inc
Columbus, Ohio, 43219, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Signal Point Clinical Research Center, LLC
Middletown, Ohio, 45042, United States
Cancer Centers of SW OK
Lawton, Oklahoma, 73505, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104, United States
Mercy Physicians of Oklahoma
Oklahoma City, Oklahoma, 73112, United States
Cancer Care Associates- Tulsa
Tulsa, Oklahoma, 74104, United States
St. Mary Medical Center Hem-Onc Group, PC
Langhorne, Pennsylvania, 19047, United States
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, 15232, United States
South Carolina Oncology Associates
Columbia, South Carolina, 29210, United States
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology
Nashville, Tennessee, 37203, United States
Medical City Dallas-US Oncology
Dallas, Texas, 75230-2510, United States
Texas Oncology, PA
Dallas, Texas, 75231-4400, United States
Texas Oncology, PA/ Methodist Charlton Cancer Center
Dallas, Texas, 75237, United States
Texas Oncology Laboratories
Fort Worth, Texas, 76104, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104, United States
The University of Texas Medical School at Houston
Houston, Texas, 77030, United States
Texas Oncology- Plano East
Plano, Texas, 75075, United States
Texas Oncology, PA
Round Rock, Texas, 76885, United States
Texas Oncology-Round Rock
Round Rock, Texas, 78681, United States
South Texas Oncology and Hematology, P.A
San Antonio, Texas, 78229, United States
Texas Oncology, PA
Wichita Falls, Texas, 76310, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Fairfax-Northern Virginia Hematology-Oncology, P.C.
Fairfax, Virginia, 22031, United States
Virginia Cancer Specialist, PC
Fairfax, Virginia, 22031, United States
Virginia Cancer Institute
Richmond, Virginia, 23230, United States
Virginia Commonwealth University
Richmond, Virginia, 23298-0037, United States
Swedish Health Services
Seattle, Washington, 98104, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
Evergreen Hematology & Oncology
Spokane, Washington, 99218, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Bankstown-Lidcombe Hospital
Bankstown, New South Wales, 2200, Australia
Macarthur Cancer Therapy Center
Campbelltown, New South Wales, 2560, Australia
Concord Hospital
Concord, New South Wales, 2139, Australia
St. Vincent's Hospital
Darlinghurst, New South Wales, 2010, Australia
Prince of Wales Hospital
Randwick, New South Wales, 2031, Australia
Newcastle Hospital
Waratah, New South Wales, 2298, Australia
Southern Medical Day Care Centre
Wollongong, New South Wales, 2500, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
Haemotology & Oncology Australasia (HOCA)
Milton, Queensland, 4101, Australia
Haematology Oncology Clinics of Australasia-Gold Coast
Milton, Queensland, 4215, Australia
Adelaide Cancer Centre (T/A Ashford Cancer Ctr)
Ashford, South Australia, 5035, Australia
Flinders Medical Center
Bedford Park, South Australia, 5042, Australia
Calvary North Adelaide Hospital
North Adelaide, South Australia, 5006, Australia
Royal Hobart Hospital
Hobart, Tasmania, 7000, Australia
Medical Oncology Unit, Bendigo Health
Bendigo, Victoria, 3552, Australia
Monash Medical Centre
East Bentleigh, Victoria, 3165, Australia
Western Hospital
Footscray, Victoria, 3011, Australia
Peninsula Oncology Centre
Frankston, Victoria, 3199, Australia
Alfred Hospital
Melbourne, Victoria, 3004, Australia
Border Medical Oncology
Wodonga, Victoria, 3690, Australia
Sir Charles Gairdner Hospital
Nedlands, Perth, Western Australia, 6009, Australia
Krankenhaus der Barmherzigen Schwestern Linz
Linz, 4010, Austria
Landesklinikum St. Pölten
Sankt Pölten, 3100, Austria
Medizinische Universität Wien
Vienna, 1090, Austria
Klinikum Wels-Grieskirchen GmbH
Wels, 4600, Austria
Imelda VZW , Gastro-Enterology
Bonheiden, 2820, Belgium
HĂ´pital Erasme, Gastro-Enterology
Brussels, 1070, Belgium
AZ Groeninge - Campus Sint-Niklaas
Kortrijk, 8500, Belgium
H.-Hartziekenhuis Roeselare-Menen vzw
Roeselare, 8800, Belgium
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
BC Cancer Agency-Vancouver
Vancouver, British Columbia, V5Z 4E6, Canada
The Royal Victoria Hospital-Barrie
Barrie, Ontario, L4M6M2, Canada
Hopital du Sacre-Coeur
Montreal, Quebec, H4J 1C5, Canada
Centre Hospitalier de L'Universite de Montreal St-Luc
Montreal, H2X3J4, Canada
Princess Margaret Hospital
Ontario, M5G 2M9, Canada
Hotel-Dieu de Quebec
Québec, G1R 2J6, Canada
Centre Regional de lutte contre le cancer Paul Papin
Angers, 49933, France
HĂ´pital Saint Antoine
Paris, 75571, France
HĂ´pital Beaujon
Paris, 92118, France
Kliniken Essen-Mitte
Essen, 45136, Germany
Klinikum Freising
Freising, 85354, Germany
Praxis fĂ¼r Innere Medizin, Dr. Oettle Helmut
Friedrichshafen, 88045, Germany
LMU Klinikum der Universität
Munich, 81377, Germany
Klinikum Oldenburg
Oldenburg, 26133, Germany
Universitätsklinikum WĂ¼rzburg
WĂ¼rzburg, 97070, Germany
I.R.C.C.S. "Giovanni Paolo II" - Istituto Oncologico
Bari, 70124, Italy
E. O. Ospedali Galliera, Struttura Complessa Oncologia Medica
Genova, 16128, Italy
Nazionale per la Ricerca sul Cancro
Genova, 16132, Italy
Fondazione Centro San Raffaele del Monte Tabor
Milan, 20132, Italy
Oncologia Medica Falck
Milan, 20162, Italy
Istituto Oncologico Veneto
Padua, 35128, Italy
IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Azienda Ospedaliero universitaria Pisana
Pisa, 56126, Italy
Arcispedale Santa Maria Nuova, UnitĂ Operativa di Oncologia Medica
Reggio Emilia, 42100, Italy
Arcispedale Santa Maria Nuova
Reggio Emilia, 42100, Italy
Istituto Nazionale Tumori "Regina Elena"
Roma, 00144, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
Ospedale Casa Sollievo della Sofferenza IRCCS
San Giovanni Rotondo, Foggia, 71013, Italy
Azienda Ospedaliera Universitaria Integrata di Verona
Verona, 37134, Italy
Med Radiological Centre of the Russian Academy of Med Sciences
Obninsk, Kaluga Oblast, 249036, Russia
Tatarstan Republican Onc Ctr
Kazan', Tatarstan Republic, 420029, Russia
Altai Territorial Oncological Center
Barnaul, 656049, Russia
Chelyabinsk Regional Onc Ctr
Chelyabinsk, 454087, Russia
Ivanovo Regional Oncology Center
Ivanovo, 153013, Russia
Regional Oncological Center # 2
Magnitogorsk, 455001, Russia
Moscow City Clinical Hosp #57 Chemotherapy Dept
Moscow, 105077, Russia
Blokhin Cancer Research Center
Moscow, 115478, Russia
Russian Res Ctr of Radiology under the Fed Agency for Hi-Tech Med Care
Moscow, 117997, Russia
Russian Research Ctr of Surgery n.a. B.V. Petrovskiy under the Russian Academy of Med Sciences
Moscow, 119992, Russia
Central Clinical Hosp of the President of the Russian Federation
Moscow, 121356, Russia
Semashko Central Hosp #2
Moscow, 129128, Russia
Moscow Municipal Onc Hosp #62
Moscow Region, 143423, Russia
Omsk Regional Onc Ctr
Omsk, 610013, Russia
Orenburg Regional Onc Ctr
Orenburg, 460021, Russia
Pyatigorsk Affiliate of Stavropol Regional Onc Ctr
Pyatigorsk, 357500, Russia
Clinical Hosp # 122 n.a. L.G. Sokolov
Saint Petersburg, 194291, Russia
Leningrad Regional Clinical Hosp
Saint Petersburg, 194291, Russia
St. Petersburg State Med Academy n.a.Mechnikov
Saint Petersburg, 195067, Russia
Russian Research Ctr for Radiology and Surgical Technologies
Saint Petersburg, 197758, Russia
St. Petersburg City Onc Ctr
Saint Petersburg, 198255, Russia
Tula Regional Oncology Center
Tula, 300053, Russia
Bashkortostan Republican Onc Ctr
Ufa, 450054, Russia
Yaroslavl Regional Onc Ctr
Yaroslavl, 150054, Russia
Hospital Vall D´Hebron
Barcelona, 08035, Spain
Hospital Clinic i Provincial
Barcelona, 8036, Spain
Hospital Universitario Reina Sofia
CĂ³rdoba, 14004, Spain
Hospital Universitario RamĂ³n y Cajal
Madrid, 28034, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital 12 de Octubre
Madrid, 28041, Spain
Centro Integral OncolĂ³gico Clara Campal
Madrid, 28050, Spain
Hospital Virgen del Rocio
Seville, 41013, Spain
Dnepropetrovsk City Hosp #4
Dnipro, UK, 49102, Ukraine
Donetsk Regional Antitumor Ctr
Donetsk, UK, 83092, Ukraine
Kirovohrad Regional Oncology Center, Department of Chemotherapy
Kirovohrad, UK, 25031, Ukraine
National Institute of Cancer, Department of Tumors of Abdominal Cavity and Retroperitoneum
Kyiv, UK, 03022, Ukraine
Kyiv City Clinical Hospital #10, Center for Hepatic, Bile Duct and Pancreatic Surgery
Kyiv, UK, 3039, Ukraine
Volyn Regional Oncology Center Department of Oncochemotherapy
Lutsk, UK, 43018, Ukraine
Lviv Regional Diagnostics and Treatment and Diagnostics Onc Ctr
Lviv, UK, 79031, Ukraine
O.F. Herbachevskyi Regional Clinical Hospital, Surgery Center
Zhytomyr, UK, 10008, Ukraine
Kharkov Regional Onc Ctr
Kharkiv, 61070, Ukraine
Kherson Regional Onc Ctr
Kherson, 73000, Ukraine
Odessa Regional Onc Ctr
Odesa, 65055, Ukraine
Zaporizhia Medical Academy of Postgraduate Education
Zaporizhia, 69096, Ukraine
Related Publications (16)
Tabernero J, Chiorean EG, Infante JR, Hingorani SR, Ganju V, Weekes C, Scheithauer W, Ramanathan RK, Goldstein D, Penenberg DN, Romano A, Ferrara S, Von Hoff DD. Prognostic factors of survival in a randomized phase III trial (MPACT) of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic pancreatic cancer. Oncologist. 2015 Feb;20(2):143-50. doi: 10.1634/theoncologist.2014-0394. Epub 2015 Jan 12.
PMID: 25582141BACKGROUNDChiorean EG, Von Hoff DD, Tabernero J, El-Maraghi R, Ma WW, Reni M, Harris M, Whorf R, Liu H, Li JS, Manax V, Romano A, Lu B, Goldstein D. Second-line therapy after nab-paclitaxel plus gemcitabine or after gemcitabine for patients with metastatic pancreatic cancer. Br J Cancer. 2016 Jul 12;115(2):188-94. doi: 10.1038/bjc.2016.185. Epub 2016 Jun 28.
PMID: 27351217BACKGROUNDTehfe M, Dowden S, Kennecke H, El-Maraghi R, Lesperance B, Couture F, Letourneau R, Liu H, Romano A. nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine in Patients with Metastatic Pancreatic Adenocarcinoma: Canadian Subgroup Analysis of the Phase 3 MPACT Trial. Adv Ther. 2016 May;33(5):747-59. doi: 10.1007/s12325-016-0327-4. Epub 2016 Apr 16.
PMID: 27085323BACKGROUNDScheithauer W, Ramanathan RK, Moore M, Macarulla T, Goldstein D, Hammel P, Kunzmann V, Liu H, McGovern D, Romano A, Von Hoff DD. Dose modification and efficacy of nab-paclitaxel plus gemcitabine vs. gemcitabine for patients with metastatic pancreatic cancer: phase III MPACT trial. J Gastrointest Oncol. 2016 Jun;7(3):469-78. doi: 10.21037/jgo.2016.01.03.
PMID: 27284481BACKGROUNDVogel A, Rommler-Zehrer J, Li JS, McGovern D, Romano A, Stahl M. Efficacy and safety profile of nab-paclitaxel plus gemcitabine in patients with metastatic pancreatic cancer treated to disease progression: a subanalysis from a phase 3 trial (MPACT). BMC Cancer. 2016 Oct 21;16(1):817. doi: 10.1186/s12885-016-2798-8.
PMID: 27769210BACKGROUNDKunzmann V, Ramanathan RK, Goldstein D, Liu H, Ferrara S, Lu B, Renschler MF, Von Hoff DD. Tumor Reduction in Primary and Metastatic Pancreatic Cancer Lesions With nab-Paclitaxel and Gemcitabine: An Exploratory Analysis From a Phase 3 Study. Pancreas. 2017 Feb;46(2):203-208. doi: 10.1097/MPA.0000000000000742.
PMID: 27841795BACKGROUNDTabernero J, Kunzmann V, Scheithauer W, Reni M, Shiansong Li J, Ferrara S, Djazouli K. nab-Paclitaxel plus gemcitabine for metastatic pancreatic cancer: a subgroup analysis of the Western European cohort of the MPACT trial. Onco Targets Ther. 2017 Feb 2;10:591-596. doi: 10.2147/OTT.S124097. eCollection 2017.
PMID: 28203092BACKGROUNDRamanathan RK, Goldstein D, Korn RL, Arena F, Moore M, Siena S, Teixeira L, Tabernero J, Van Laethem JL, Liu H, McGovern D, Lu B, Von Hoff DD. Positron emission tomography response evaluation from a randomized phase III trial of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone for patients with metastatic adenocarcinoma of the pancreas. Ann Oncol. 2016 Apr;27(4):648-53. doi: 10.1093/annonc/mdw020. Epub 2016 Jan 22.
PMID: 26802153RESULTChiorean EG, Von Hoff DD, Reni M, Arena FP, Infante JR, Bathini VG, Wood TE, Mainwaring PN, Muldoon RT, Clingan PR, Kunzmann V, Ramanathan RK, Tabernero J, Goldstein D, McGovern D, Lu B, Ko A. CA19-9 decrease at 8 weeks as a predictor of overall survival in a randomized phase III trial (MPACT) of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic pancreatic cancer. Ann Oncol. 2016 Apr;27(4):654-60. doi: 10.1093/annonc/mdw006. Epub 2016 Jan 22.
PMID: 26802160RESULTGoldstein D, Von Hoff DD, Moore M, Greeno E, Tortora G, Ramanathan RK, Macarulla T, Liu H, Pilot R, Ferrara S, Lu B. Development of peripheral neuropathy and its association with survival during treatment with nab-paclitaxel plus gemcitabine for patients with metastatic adenocarcinoma of the pancreas: A subset analysis from a randomised phase III trial (MPACT). Eur J Cancer. 2016 Jan;52:85-91. doi: 10.1016/j.ejca.2015.10.017. Epub 2015 Dec 1.
PMID: 26655559RESULTPortal A, Pernot S, Tougeron D, Arbaud C, Bidault AT, de la Fouchardiere C, Hammel P, Lecomte T, Dreanic J, Coriat R, Bachet JB, Dubreuil O, Marthey L, Dahan L, Tchoundjeu B, Locher C, Lepere C, Bonnetain F, Taieb J. Nab-paclitaxel plus gemcitabine for metastatic pancreatic adenocarcinoma after Folfirinox failure: an AGEO prospective multicentre cohort. Br J Cancer. 2015 Sep 29;113(7):989-95. doi: 10.1038/bjc.2015.328. Epub 2015 Sep 15.
PMID: 26372701RESULTGoldstein D, El-Maraghi RH, Hammel P, Heinemann V, Kunzmann V, Sastre J, Scheithauer W, Siena S, Tabernero J, Teixeira L, Tortora G, Van Laethem JL, Young R, Penenberg DN, Lu B, Romano A, Von Hoff DD. nab-Paclitaxel plus gemcitabine for metastatic pancreatic cancer: long-term survival from a phase III trial. J Natl Cancer Inst. 2015 Jan 31;107(2):dju413. doi: 10.1093/jnci/dju413. Print 2015 Feb.
PMID: 25638248RESULTVogel A, Pelzer U, Salah-Eddin AB, Koster W. First-line nab-paclitaxel and gemcitabine in patients with metastatic pancreatic cancer from routine clinical practice. In Vivo. 2014 Nov-Dec;28(6):1135-40.
PMID: 25398812RESULTVon Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16.
PMID: 24131140RESULTVon Hoff DD, Cridebring D, Tian OY, Han H, Bhore R, Franco T, Ondovik MS, Louis CU. Analysis of the Role of Plasma 25-Hydroxyvitamin D Levels in Survival Outcomes in Patients from the Phase III MPACT Trial of Metastatic Pancreatic Cancer. Oncologist. 2021 Apr;26(4):e704-e709. doi: 10.1002/onco.13645. Epub 2021 Jan 11.
PMID: 33345430DERIVEDMcCleary-Wheeler AL, McWilliams R, Fernandez-Zapico ME. Aberrant signaling pathways in pancreatic cancer: a two compartment view. Mol Carcinog. 2012 Jan;51(1):25-39. doi: 10.1002/mc.20827.
PMID: 22162229DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Anne McClain
- Organization
- Celgene Corporation
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Von Hoff, MD
Scottsdale Clinical Research Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2009
First Posted
February 16, 2009
Study Start
March 1, 2009
Primary Completion
September 17, 2012
Study Completion
April 9, 2013
Last Updated
November 25, 2019
Results First Posted
December 11, 2013
Record last verified: 2019-11