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Brief Title: Phase III Study of ABI-007(Albumin-bound Paclitaxel) Plus Gemcitabine Versus Gemcitabine in Metastatic Adenocarcinoma of the Pancreas
Official Title: A Randomized Phase III Study of Weekly ABI-007 Plus Gemcitabine Versus Gemcitabine Alone in Patients With Metastatic Adenocarcinoma of the Pancreas
Study ID: NCT00844649
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
UAB Comprenhensive Cancer Center at University of Alabama, Birmingham, Alabama, United States
Clearview Cancer Institute Oncology Specialities, P.C., Huntsville, Alabama, United States
TGEN Clinical Research Services at Scottsdale Healthcare, Scottsdale, Arizona, United States
Mayo Clinic-Scottsdale, Scottsdale, Arizona, United States
Northern Arizona Hematology and Oncology Associates-AOA, Sedona, Arizona, United States
Arizona Cancer Center, University of Arizona, Tucson, Arizona, United States
Genesis Cancer Center, Hot Springs, Arkansas, United States
Tower Cancer Research Foundation, Beverly Hills, California, United States
City of Hope, Duarte, California, United States
Pacific Shores Medical Group, Long Beach, California, United States
UCLA, Los Angeles, California, United States
Desert Hematology Oncology Medical Group, Inc., Rancho Mirage, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Rocky Mountain Cancer Center, Denver, Colorado, United States
University Cancer Institute, LLC, Boynton Beach, Florida, United States
Collaborative Research Group, Boynton Beach, Florida, United States
FL Cancer Specialist, Fort Myers, Florida, United States
Lakeland Regional Cancer Center, Lakeland, Florida, United States
Ocala Oncology Center, Ocala, Florida, United States
Florida Hospital Cancer Institute, Orlando, Florida, United States
Lake County Oncology and Hematology, Tavares, Florida, United States
Phoebe Putney Cancer Center, Albany, Georgia, United States
Northeast Georgia Cancer Care, LLC, Athens, Georgia, United States
Piedmont Hospital Research Institute, Atlanta, Georgia, United States
Georgia Cancer Specialists, Atlanta, Georgia, United States
Atlanta Cancer Care, Atlanta, Georgia, United States
Cancer Care & Hemaotology Specialists of Chicagoland, Arlington Heights, Illinois, United States
NorthShore University HealthSystem, Evanston, Illinois, United States
Cancer Care & Hematology Specialists of Chicagoland, Niles, Illinois, United States
Illinois Cancer Care, Peoria, Illinois, United States
Orchard Research, Skokie, Illinois, United States
Indiana University Simon Cancer Center, Indianapolis, Indiana, United States
Hutchinson Clinic, PA, Hutchinson, Kansas, United States
Owsley Brown Frazier Cancer Center, Louisville, Kentucky, United States
Hematology Oncology Clinic, Baton Rouge, Louisiana, United States
Mary Bird Perkins Cancer Center, Baton Rouge, Louisiana, United States
Central Maine Medical Center, Lewiston, Maine, United States
Mercy Hospital Portland, ME, Portland, Maine, United States
Maine Center for Cancer Medicine, Scarborough, Maine, United States
Sidney Kimmel Comphrensive Cancer Center, John Hopkins University, Baltimore, Maryland, United States
Center for Cancer & Blood Disorders, Bethesda, Maryland, United States
Lahey Clinic, Burlington, Massachusetts, United States
Cancer Center of Excellence/University of MA Medical School, Worcester, Massachusetts, United States
St. Mary's/ Duluth Clinic, Duluth, Minnesota, United States
Virginia Piper Cancer Institute, Minneapolis, Minnesota, United States
University of Minnesota, Masonic Cancer Center, Minneapolis, Minnesota, United States
Saint Louis University, Saint Louis, Missouri, United States
St. John's Medical Research Institute, Springfield, Missouri, United States
The Center for Cancer and Hematologic Disease, Cherry Hill, New Jersey, United States
Hem Onc Associates-NM, Albuquerque, New Mexico, United States
University of New Mexico, Albuquerque, New Mexico, United States
New York Oncology Hematology PC, Albany, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Arena Oncology Associates, PC, Lake Success, New York, United States
SUNY Upstate Medical University, Syracuse, New York, United States
Piedmont Hematology Oncology, Winston-Salem, North Carolina, United States
Oncology Hematology Care, Cincinnati, Ohio, United States
Mid Ohio Oncology/Hematology Inc, Columbus, Ohio, United States
Kettering Medical Center, Kettering, Ohio, United States
Signal Point Clinical Research Center, LLC, Middletown, Ohio, United States
Cancer Centers of SW OK, Lawton, Oklahoma, United States
University of Oklahoma Health Science Center, Oklahoma City, Oklahoma, United States
Mercy Physicians of Oklahoma, Oklahoma City, Oklahoma, United States
Cancer Care Associates- Tulsa, Tulsa, Oklahoma, United States
St. Mary Medical Center Hem-Onc Group, PC, Langhorne, Pennsylvania, United States
University of Pittsburg Medical Center, Pittsburgh, Pennsylvania, United States
South Carolina Oncology Associates, Columbia, South Carolina, United States
Chattanooga Oncology Hematology Associates, Chattanooga, Tennessee, United States
Tennessee Oncology, Nashville, Tennessee, United States
Medical City Dallas-US Oncology, Dallas, Texas, United States
Texas Oncology, PA, Dallas, Texas, United States
Texas Oncology, PA/ Methodist Charlton Cancer Center, Dallas, Texas, United States
Texas Oncology Laboratories, Fort Worth, Texas, United States
The Center for Cancer and Blood Disorders, Fort Worth, Texas, United States
The University of Texas Medical School at Houston, Houston, Texas, United States
Texas Oncology- Plano East, Plano, Texas, United States
Texas Oncology, PA, Round Rock, Texas, United States
Texas Oncology-Round Rock, Round Rock, Texas, United States
South Texas Oncology and Hematology, P.A, San Antonio, Texas, United States
Texas Oncology, PA, Wichita Falls, Texas, United States
Utah Cancer Specialists, Salt Lake City, Utah, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Fairfax-Northern Virginia Hematology-Oncology, P.C., Fairfax, Virginia, United States
Virginia Cancer Specialist, PC, Fairfax, Virginia, United States
Virginia Cancer Institute, Richmond, Virginia, United States
Virginia Commonwealth University, Richmond, Virginia, United States
Swedish Health Services, Seattle, Washington, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Evergreen Hematology & Oncology, Spokane, Washington, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Bankstown-Lidcombe Hospital, Bankstown, New South Wales, Australia
Macarthur Cancer Therapy Center, Campbelltown, New South Wales, Australia
Concord Hospital, Concord, New South Wales, Australia
St. Vincent's Hospital, Darlinghurst, New South Wales, Australia
Prince of Wales Hospital, Randwick, New South Wales, Australia
Newcastle Hospital, Waratah, New South Wales, Australia
Southern Medical Day Care Centre, Wollongong, New South Wales, Australia
Royal Brisbane and Women's Hospital, Herston, Queensland, Australia
Haemotology & Oncology Australasia (HOCA), Milton, Queensland, Australia
Haematology Oncology Clinics of Australasia-Gold Coast, Milton, Queensland, Australia
Adelaide Cancer Centre (T/A Ashford Cancer Ctr), Ashford, South Australia, Australia
Flinders Medical Center, Bedford Park, South Australia, Australia
Calvary North Adelaide Hospital, North Adelaide, South Australia, Australia
Royal Hobart Hospital, Hobart, Tasmania, Australia
Medical Oncology Unit, Bendigo Health, Bendigo, Victoria, Australia
Monash Medical Centre, East Bentleigh, Victoria, Australia
Western Hospital, Footscray, Victoria, Australia
Peninsula Oncology Centre, Frankston, Victoria, Australia
Alfred Hospital, Melbourne, Victoria, Australia
Border Medical Oncology, Wodonga, Victoria, Australia
Sir Charles Gairdner Hospital, Nedlands, Perth, Western Australia, Australia
Krankenhaus der Barmherzigen Schwestern Linz, Linz, , Austria
Landesklinikum St. Pölten, St. Pölten, , Austria
Medizinische Universität Wien, Vienna, , Austria
Klinikum Wels-Grieskirchen GmbH, Wels, , Austria
Imelda VZW , Gastro-Enterology, Bonheiden, , Belgium
Hôpital Erasme, Gastro-Enterology, Brussels, , Belgium
AZ Groeninge - Campus Sint-Niklaas, Kortrijk, , Belgium
H.-Hartziekenhuis Roeselare-Menen vzw, Roeselare, , Belgium
Tom Baker Cancer Centre, Calgary, Alberta, Canada
BC Cancer Agency-Vancouver, Vancouver, British Columbia, Canada
The Royal Victoria Hospital-Barrie, Barrie, Ontario, Canada
Hopital du Sacre-Coeur, Montreal, Quebec, Canada
Centre Hospitalier de L'Universite de Montreal St-Luc, Montreal, , Canada
Princess Margaret Hospital, Ontario, , Canada
Hotel-Dieu de Quebec, Quebec, , Canada
Centre Regional de lutte contre le cancer Paul Papin, Angers, , France
Hôpital Saint Antoine, Paris, , France
Hôpital Beaujon, Paris, , France
Kliniken Essen-Mitte, Essen, , Germany
Klinikum Freising, Freising, , Germany
Praxis für Innere Medizin, Dr. Oettle Helmut, Friedrichshafen, , Germany
LMU Klinikum der Universität, Munich, , Germany
Klinikum Oldenburg, Oldenburg, , Germany
Universitätsklinikum Würzburg, Würzburg, , Germany
I.R.C.C.S. "Giovanni Paolo II" - Istituto Oncologico, Bari, , Italy
E. O. Ospedali Galliera, Struttura Complessa Oncologia Medica, Genova, , Italy
Nazionale per la Ricerca sul Cancro, Genova, , Italy
Fondazione Centro San Raffaele del Monte Tabor, Milano, , Italy
Oncologia Medica Falck, Milano, , Italy
Istituto Oncologico Veneto, Padova, , Italy
IRCCS Policlinico San Matteo, Pavia, , Italy
Azienda Ospedaliero universitaria Pisana, Pisa, , Italy
Arcispedale Santa Maria Nuova, Unità Operativa di Oncologia Medica, Reggio Emilia, , Italy
Arcispedale Santa Maria Nuova, Reggio Emilia, , Italy
Istituto Nazionale Tumori "Regina Elena", Roma, , Italy
Istituto Clinico Humanitas, Rozzano, , Italy
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
Tatarstan Republican Onc Ctr, Kazan, Republic Of Tatarstan, Russian Federation
Altai Territorial Oncological Center, Barnaul, , Russian Federation
Chelyabinsk Regional Onc Ctr, Chelyabinsk, , Russian Federation
Ivanovo Regional Oncology Center, Ivanovo, , Russian Federation
Regional Oncological Center # 2, Magnitogorsk, , Russian Federation
Moscow Municipal Onc Hosp #62, Moscow Region, , Russian Federation
Moscow City Clinical Hosp #57 Chemotherapy Dept, Moscow, , Russian Federation
Blokhin Cancer Research Center, Moscow, , Russian Federation
Russian Res Ctr of Radiology under the Fed Agency for Hi-Tech Med Care, Moscow, , Russian Federation
Russian Research Ctr of Surgery n.a. B.V. Petrovskiy under the Russian Academy of Med Sciences, Moscow, , Russian Federation
Central Clinical Hosp of the President of the Russian Federation, Moscow, , Russian Federation
Semashko Central Hosp #2, Moscow, , Russian Federation
Omsk Regional Onc Ctr, Omsk, , Russian Federation
Orenburg Regional Onc Ctr, Orenburg, , Russian Federation
Pyatigorsk Affiliate of Stavropol Regional Onc Ctr, Pyatigorsk, , Russian Federation
St. Petersburg State Med Academy n.a.Mechnikov, St Petersburg, , Russian Federation
Russian Research Ctr for Radiology and Surgical Technologies, St Petersburg, , Russian Federation
Clinical Hosp # 122 n.a. L.G. Sokolov, St. Petersburg, , Russian Federation
Leningrad Regional Clinical Hosp, St. Petersburg, , Russian Federation
St. Petersburg City Onc Ctr, St. Petersburg, , Russian Federation
Tula Regional Oncology Center, Tula, , Russian Federation
Bashkortostan Republican Onc Ctr, Ufa, , Russian Federation
Yaroslavl Regional Onc Ctr, Yaroslavl, , Russian Federation
Hospital Vall D´Hebron, Barcelona, , Spain
Hospital Clinic i Provincial, Barcelona, , Spain
Hospital Universitario Reina Sofia, Córdoba, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital 12 de Octubre, Madrid, , Spain
Centro Integral Oncológico Clara Campal, Madrid, , Spain
Hospital Virgen del Rocio, Sevilla, , Spain
Dnepropetrovsk City Hosp #4, Dnepropetrovsk, UK, Ukraine
Donetsk Regional Antitumor Ctr, Donetsk, UK, Ukraine
Kirovohrad Regional Oncology Center, Department of Chemotherapy, Kirovohrad, 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
Volyn Regional Oncology Center Department of Oncochemotherapy, Lutsk, UK, Ukraine
Lviv Regional Diagnostics and Treatment and Diagnostics Onc Ctr, Lviv, UK, Ukraine
O.F. Herbachevskyi Regional Clinical Hospital, Surgery Center, Zhytomyr, UK, Ukraine
Kharkov Regional Onc Ctr, Kharkov, , Ukraine
Kherson Regional Onc Ctr, Kherson, , Ukraine
Odessa Regional Onc Ctr, Odessa, , Ukraine
Zaporizhia Medical Academy of Postgraduate Education, Zaporizhia, , Ukraine
Name: Daniel Von Hoff, MD
Affiliation: Scottsdale Clinical Research Institute
Role: PRINCIPAL_INVESTIGATOR