Phase III Study of ABI-007(Albumin-bound Paclitaxel) Plus Gemcitabine Versus Gemcitabine in Metastatic Adenocarcinoma of the Pancreas
- Conditions
- Metastatic Pancreatic Cancer
- Interventions
- Registration Number
- NCT00844649
- Lead Sponsor
- Celgene
- Brief Summary
Phase III Metastatic Pancreatic Cancer
- Detailed Description
A Phase III, open-label randomized, multicenter trial to compare ABI-007(Albumin-bound Paclitaxel)in combination with gemcitabine administered weekly to standard treatment (gemcitabine monotherapy) with respect to overall survival, objective tumor response rate and Progression Free Survival (PFS) in patients diagnosed with metastatic adenocarcinoma of the pancreas.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 861
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Albumin-bound paclitaxel (ABI-007)/Gemcitabine Gemcitabine ABI-007 125 mg/m2 administered in combination with gemcitabine 1000 mg/m2 weekly for 3 weeks followed by one week of rest. Albumin-bound paclitaxel (ABI-007)/Gemcitabine Albumin-bound paclitaxel (ABI-007) ABI-007 125 mg/m2 administered in combination with gemcitabine 1000 mg/m2 weekly for 3 weeks followed by one week of rest. Gemcitabine Gemcitabine Gemcitabine, 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).
- Primary Outcome Measures
Name Time Method Overall Survival (OS) From randomization to death; until the data cut off 17 Sept 2012. The maximum time in follow up was 37 months. 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.
- Secondary Outcome Measures
Name Time Method 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. Progression-free survival was defined as the time from the date of randomization to the date of disease progression, or death (any cause) on or prior to the clinical cutoff date, whichever occurred earlier. Participants who did not have disease progression or had not died were censored at the date of the last tumor assessment, on or prior to the clinical cutoff, and the patient was progression free. If a patient began a new anti-cancer treatment prior to documented disease progression (or death), the patient was censored at the date of last assessment when the patient was documented as progression free prior to the intervention. Patients with two or more consecutive missing response assessments prior to a visit with documented progression (or death) were censored at the last date of tumor assessment when the patient was documented to be progression free. PFS was summarized using Kaplan-Meier methods.
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 Objective tumor response was summarized as the percentage of participants who achieved a confirmed complete (CR) or partial response (PR) based on an independent blinded radiology assessment of response using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Using RECIST Version 1.0, participants were to achieve either a complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the investigator assessment of best overall response during study treatment.
Trial Locations
- Locations (191)
Tower Cancer Research Foundation
🇺🇸Beverly Hills, California, United States
Phoebe Putney Cancer Center
🇺🇸Albany, Georgia, United States
Cancer Care & Hematology Specialists of Chicagoland
🇺🇸Niles, Illinois, United States
Piedmont Hospital Research Institute
🇺🇸Atlanta, Georgia, United States
Lakeland Regional Cancer Center
🇺🇸Lakeland, Florida, United States
Georgia Cancer Specialists
🇺🇸Atlanta, Georgia, United States
Mercy Hospital Portland, ME
🇺🇸Portland, Maine, United States
Cancer Care & Hemaotology Specialists of Chicagoland
🇺🇸Arlington Heights, Illinois, United States
Maine Center for Cancer Medicine
🇺🇸Scarborough, Maine, United States
Ocala Oncology Center
🇺🇸Ocala, Florida, United States
Northeast Georgia Cancer Care, LLC
🇺🇸Athens, Georgia, United States
Lake County Oncology and Hematology
🇺🇸Tavares, Florida, United States
The Center for Cancer and Hematologic Disease
🇺🇸Cherry Hill, New Jersey, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
NorthShore University HealthSystem
🇺🇸Evanston, Illinois, United States
Desert Hematology Oncology Medical Group, Inc.
🇺🇸Rancho Mirage, California, United States
Medical City Dallas-US Oncology
🇺🇸Dallas, Texas, United States
Hematology Oncology Clinic
🇺🇸Baton Rouge, Louisiana, United States
Arena Oncology Associates, PC
🇺🇸Lake Success, New York, United States
The Center for Cancer and Blood Disorders
🇺🇸Fort Worth, Texas, United States
Oncology Hematology Care
🇺🇸Cincinnati, Ohio, United States
Mary Bird Perkins Cancer Center
🇺🇸Baton Rouge, Louisiana, United States
St. John's Medical Research Institute
🇺🇸Springfield, Missouri, United States
Flinders Medical Center
🇦🇺Bedford Park, South Australia, Australia
Signal Point Clinical Research Center, LLC
🇺🇸Middletown, Ohio, United States
Chattanooga Oncology Hematology Associates
🇺🇸Chattanooga, Tennessee, United States
Fairfax-Northern Virginia Hematology-Oncology, P.C.
🇺🇸Fairfax, Virginia, United States
New York Oncology Hematology PC
🇺🇸Albany, New York, United States
University of Pittsburg Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Cancer Care Associates- Tulsa
🇺🇸Tulsa, Oklahoma, United States
Hem Onc Associates-NM
🇺🇸Albuquerque, New Mexico, United States
Texas Oncology- Plano East
🇺🇸Plano, Texas, United States
Bankstown-Lidcombe Hospital
🇦🇺Bankstown, New South Wales, Australia
Concord Hospital
🇦🇺Concord, New South Wales, Australia
Virginia Cancer Specialist, PC
🇺🇸Fairfax, Virginia, United States
E. O. Ospedali Galliera, Struttura Complessa Oncologia Medica
🇮🇹Genova, Italy
Hôpital Beaujon
🇫🇷Paris, France
Calvary North Adelaide Hospital
🇦🇺North Adelaide, South Australia, Australia
Centre Hospitalier de L'Universite de Montreal St-Luc
🇨🇦Montreal, Canada
Hotel-Dieu de Quebec
🇨🇦Quebec, Canada
Universitätsklinikum Würzburg
🇩🇪Würzburg, Germany
Kliniken Essen-Mitte
🇩🇪Essen, Germany
Landesklinikum St. Pölten
🇦🇹St. Pölten, Austria
Hospital Clinic i Provincial
🇪🇸Barcelona, Spain
Azienda Ospedaliero universitaria Pisana
🇮🇹Pisa, Italy
Centre Regional de lutte contre le cancer Paul Papin
🇫🇷Angers, France
Adelaide Cancer Centre (T/A Ashford Cancer Ctr)
🇦🇺Ashford, South Australia, Australia
Klinikum Oldenburg
🇩🇪Oldenburg, Germany
LMU Klinikum der Universität
🇩🇪Munich, Germany
Haematology Oncology Clinics of Australasia-Gold Coast
🇦🇺Milton, Queensland, Australia
Praxis für Innere Medizin, Dr. Oettle Helmut
🇩🇪Friedrichshafen, Germany
Hopital du Sacre-Coeur
🇨🇦Montreal, Quebec, Canada
Nazionale per la Ricerca sul Cancro
🇮🇹Genova, Italy
Klinikum Freising
🇩🇪Freising, Germany
Arcispedale Santa Maria Nuova
🇮🇹Reggio Emilia, Italy
Hospital Universitario Reina Sofia
🇪🇸Córdoba, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Hospital Vall D´Hebron
🇪🇸Barcelona, Spain
The University of Texas Medical School at Houston
🇺🇸Houston, Texas, United States
Swedish Health Services
🇺🇸Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Hutchinson Clinic, PA
🇺🇸Hutchinson, Kansas, United States
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Perth, Western Australia, Australia
Indiana University Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
University of Minnesota, Masonic Cancer Center
🇺🇸Minneapolis, Minnesota, United States
South Texas Oncology and Hematology, P.A
🇺🇸San Antonio, Texas, United States
University of Oklahoma Health Science Center
🇺🇸Oklahoma City, Oklahoma, United States
Utah Cancer Specialists
🇺🇸Salt Lake City, Utah, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Virginia Piper Cancer Institute
🇺🇸Minneapolis, Minnesota, United States
Mercy Physicians of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Tennessee Oncology
🇺🇸Nashville, Tennessee, United States
Chelyabinsk Regional Onc Ctr
🇷🇺Chelyabinsk, Russian Federation
Semashko Central Hosp #2
🇷🇺Moscow, Russian Federation
Kirovohrad Regional Oncology Center, Department of Chemotherapy
🇺🇦Kirovohrad, UK, Ukraine
Odessa Regional Onc Ctr
🇺🇦Odessa, Ukraine
IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy
I.R.C.C.S. "Giovanni Paolo II" - Istituto Oncologico
🇮🇹Bari, Italy
Fondazione Centro San Raffaele del Monte Tabor
🇮🇹Milano, Italy
Oncologia Medica Falck
🇮🇹Milano, Italy
Istituto Oncologico Veneto
🇮🇹Padova, Italy
Arcispedale Santa Maria Nuova, Unità Operativa di Oncologia Medica
🇮🇹Reggio Emilia, Italy
Istituto Nazionale Tumori "Regina Elena"
🇮🇹Roma, Italy
Istituto Clinico Humanitas
🇮🇹Rozzano, Italy
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Western Hospital
🇦🇺Footscray, Victoria, Australia
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Border Medical Oncology
🇦🇺Wodonga, Victoria, Australia
Imelda VZW , Gastro-Enterology
🇧🇪Bonheiden, Belgium
Royal Hobart Hospital
🇦🇺Hobart, Tasmania, Australia
Medical Oncology Unit, Bendigo Health
🇦🇺Bendigo, Victoria, Australia
Russian Research Ctr of Surgery n.a. B.V. Petrovskiy under the Russian Academy of Med Sciences
🇷🇺Moscow, Russian Federation
Peninsula Oncology Centre
🇦🇺Frankston, Victoria, Australia
Krankenhaus der Barmherzigen Schwestern Linz
🇦🇹Linz, Austria
Medizinische Universität Wien
🇦🇹Vienna, Austria
Klinikum Wels-Grieskirchen GmbH
🇦🇹Wels, Austria
AZ Groeninge - Campus Sint-Niklaas
🇧🇪Kortrijk, Belgium
H.-Hartziekenhuis Roeselare-Menen vzw
🇧🇪Roeselare, Belgium
Altai Territorial Oncological Center
🇷🇺Barnaul, Russian Federation
Tatarstan Republican Onc Ctr
🇷🇺Kazan, Republic Of Tatarstan, Russian Federation
Blokhin Cancer Research Center
🇷🇺Moscow, Russian Federation
Regional Oncological Center # 2
🇷🇺Magnitogorsk, Russian Federation
Ivanovo Regional Oncology Center
🇷🇺Ivanovo, Russian Federation
Moscow Municipal Onc Hosp #62
🇷🇺Moscow Region, Russian Federation
Clinical Hosp # 122 n.a. L.G. Sokolov
🇷🇺St. Petersburg, Russian Federation
Orenburg Regional Onc Ctr
🇷🇺Orenburg, Russian Federation
Pyatigorsk Affiliate of Stavropol Regional Onc Ctr
🇷🇺Pyatigorsk, Russian Federation
Leningrad Regional Clinical Hosp
🇷🇺St. Petersburg, Russian Federation
Donetsk Regional Antitumor Ctr
🇺🇦Donetsk, UK, Ukraine
Volyn Regional Oncology Center Department of Oncochemotherapy
🇺🇦Lutsk, UK, Ukraine
O.F. Herbachevskyi Regional Clinical Hospital, Surgery Center
🇺🇦Zhytomyr, UK, Ukraine
Zaporizhia Medical Academy of Postgraduate Education
🇺🇦Zaporizhia, Ukraine
Moscow City Clinical Hosp #57 Chemotherapy Dept
🇷🇺Moscow, Russian Federation
Central Clinical Hosp of the President of the Russian Federation
🇷🇺Moscow, Russian Federation
Russian Research Ctr for Radiology and Surgical Technologies
🇷🇺St Petersburg, Russian Federation
St. Petersburg City Onc Ctr
🇷🇺St. Petersburg, Russian Federation
Omsk Regional Onc Ctr
🇷🇺Omsk, Russian Federation
Tula Regional Oncology Center
🇷🇺Tula, Russian Federation
Lviv Regional Diagnostics and Treatment and Diagnostics Onc Ctr
🇺🇦Lviv, UK, Ukraine
National Institute of Cancer, Department of Tumors of Abdominal Cavity and Retroperitoneum
🇺🇦Kyiv, UK, Ukraine
Kyiv City Clinical Hospital #10, Center for Hepatic, Bile Duct and Pancreatic Surgery
🇺🇦Kyiv, UK, Ukraine
Kharkov Regional Onc Ctr
🇺🇦Kharkov, Ukraine
Hospital Virgen del Rocio
🇪🇸Sevilla, Spain
UAB Comprenhensive Cancer Center at University of Alabama
🇺🇸Birmingham, Alabama, United States
Rocky Mountain Cancer Center
🇺🇸Denver, Colorado, United States
University of Colorado Cancer Center
🇺🇸Aurora, Colorado, United States
Center for Cancer & Blood Disorders
🇺🇸Bethesda, Maryland, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Newcastle Hospital
🇦🇺Waratah, New South Wales, Australia
Hôpital Saint Antoine
🇫🇷Paris, France
City of Hope
🇺🇸Duarte, California, United States
Pacific Shores Medical Group
🇺🇸Long Beach, California, United States
UCLA
🇺🇸Los Angeles, California, United States
University Cancer Institute, LLC
🇺🇸Boynton Beach, Florida, United States
Atlanta Cancer Care
🇺🇸Atlanta, Georgia, United States
Central Maine Medical Center
🇺🇸Lewiston, Maine, United States
Sidney Kimmel Comphrensive Cancer Center, John Hopkins University
🇺🇸Baltimore, Maryland, United States
Cancer Center of Excellence/University of MA Medical School
🇺🇸Worcester, Massachusetts, United States
Lahey Clinic
🇺🇸Burlington, Massachusetts, United States
St. Mary's/ Duluth Clinic
🇺🇸Duluth, Minnesota, United States
TGEN Clinical Research Services at Scottsdale Healthcare
🇺🇸Scottsdale, Arizona, United States
Clearview Cancer Institute Oncology Specialities, P.C.
🇺🇸Huntsville, Alabama, United States
Northern Arizona Hematology and Oncology Associates-AOA
🇺🇸Sedona, Arizona, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Mayo Clinic-Scottsdale
🇺🇸Scottsdale, Arizona, United States
Collaborative Research Group
🇺🇸Boynton Beach, Florida, United States
Arizona Cancer Center, University of Arizona
🇺🇸Tucson, Arizona, United States
Genesis Cancer Center
🇺🇸Hot Springs, Arkansas, United States
Mid Ohio Oncology/Hematology Inc
🇺🇸Columbus, Ohio, United States
FL Cancer Specialist
🇺🇸Fort Myers, Florida, United States
Illinois Cancer Care
🇺🇸Peoria, Illinois, United States
Orchard Research
🇺🇸Skokie, Illinois, United States
Kettering Medical Center
🇺🇸Kettering, Ohio, United States
Cancer Centers of SW OK
🇺🇸Lawton, Oklahoma, United States
South Carolina Oncology Associates
🇺🇸Columbia, South Carolina, United States
St. Mary Medical Center Hem-Onc Group, PC
🇺🇸Langhorne, Pennsylvania, United States
Texas Oncology, PA
🇺🇸Wichita Falls, Texas, United States
Texas Oncology Laboratories
🇺🇸Fort Worth, Texas, United States
Texas Oncology, PA/ Methodist Charlton Cancer Center
🇺🇸Dallas, Texas, United States
Macarthur Cancer Therapy Center
🇦🇺Campbelltown, New South Wales, Australia
Prince of Wales Hospital
🇦🇺Randwick, New South Wales, Australia
Southern Medical Day Care Centre
🇦🇺Wollongong, New South Wales, Australia
St. Vincent's Hospital
🇦🇺Darlinghurst, New South Wales, Australia
Royal Brisbane and Women's Hospital
🇦🇺Herston, Queensland, Australia
Monash Medical Centre
🇦🇺East Bentleigh, Victoria, Australia
Hôpital Erasme, Gastro-Enterology
🇧🇪Brussels, Belgium
Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada
Princess Margaret Hospital
🇨🇦Ontario, Canada
Ospedale Casa Sollievo della Sofferenza IRCCS
🇮🇹San Giovanni Rotondo, Foggia, Italy
Azienda Ospedaliera Universitaria Integrata di Verona
🇮🇹Verona, Italy
Med Radiological Centre of the Russian Academy of Med Sciences
🇷🇺Obninsk, Kaluga Region, Russian Federation
Russian Res Ctr of Radiology under the Fed Agency for Hi-Tech Med Care
🇷🇺Moscow, Russian Federation
St. Petersburg State Med Academy n.a.Mechnikov
🇷🇺St Petersburg, Russian Federation
Bashkortostan Republican Onc Ctr
🇷🇺Ufa, Russian Federation
Yaroslavl Regional Onc Ctr
🇷🇺Yaroslavl, Russian Federation
Centro Integral Oncológico Clara Campal
🇪🇸Madrid, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Dnepropetrovsk City Hosp #4
🇺🇦Dnepropetrovsk, UK, Ukraine
Kherson Regional Onc Ctr
🇺🇦Kherson, Ukraine
Evergreen Hematology & Oncology
🇺🇸Spokane, Washington, United States
Haemotology & Oncology Australasia (HOCA)
🇦🇺Milton, Queensland, Australia
Saint Louis University
🇺🇸Saint Louis, Missouri, United States
Texas Oncology-Round Rock
🇺🇸Round Rock, Texas, United States
Florida Hospital Cancer Institute
🇺🇸Orlando, Florida, United States
Owsley Brown Frazier Cancer Center
🇺🇸Louisville, Kentucky, United States
Piedmont Hematology Oncology
🇺🇸Winston-Salem, North Carolina, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Virginia Cancer Institute
🇺🇸Richmond, Virginia, United States
BC Cancer Agency-Vancouver
🇨🇦Vancouver, British Columbia, Canada
The Royal Victoria Hospital-Barrie
🇨🇦Barrie, Ontario, Canada