Spots Global Cancer Trial Database for AMR PH GL 2007 CL001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy
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Trial Identification
Brief Title: AMR PH GL 2007 CL001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy
Official Title: AMR PH GL 2007 CL001 Phase 3 A Randomized, Open-Label, Multinational Phase 3 Trial Comparing Amrubicin Versus Topotecan in Patients With Extensive or Limited and Sensitive or Refractory Small Cell Lung Cancer After Failure of First-Line Chemotherapy
Study ID: NCT00547651
Conditions
Study Description
Brief Summary: This study drug (Amrubicin) is believed to work by stopping the tumor cells in your body from growing. The purpose of this study is to evaluate the effect of amrubicin compared to topotecan in the treatment of small cell lung cancer.
Detailed Description: Small cell lung cancer represents approximately 13% of the cancers of the lung and presents as extensive stage disease in 60% to 70% of patients. Sites of metastases include bone (35%), liver (25%), bone marrow (20%), brain (10%), extrathoracic lymph nodes (5%), and subcutaneous masses (5%). Small-cell lung cancer has prominent markers of neuroendocrine differentiation. The staging classification for SCLC is the 2-stage Veterans Administration Lung Study Group system that categorizes patients as having limited or extensive disease. Limited stage SCLC is disease confined to 1 hemithorax with or without adjacent mediastinal and/or supraclavicular lymph node involvement, but without a pleural effusion. This extent of disease can be included in a tolerable radiation field. Extensive-disease SCLC is any disease beyond the definition of limited-stage disease. There are few proven treatment options for SCLC patients who fail first-line chemotherapy. New treatment strategies must be evaluated. The need to discover active agents with better toxicity profiles continues to be of great importance. Amrubicin may be an effective treatment for this population.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Northwest Alabama Cancer Center, Muscle Shoals, Alabama, United States
Arizona Oncology Associates, Tucson, Arizona, United States
Little Rock Hematology Oncology Associates, Little Rock, Arkansas, United States
Cancer Care Associates of Fresno Medical Group, Inc., Fresno, California, United States
Cedars-Sinai Outpatient Cancer Center, Los Angeles, California, United States
University of Colorado Health Science Centre, Aurora, Colorado, United States
Rocky Mountain Cancer Center - Midtown (Main), Denver, Colorado, United States
Advanced Medical Specialties, Miami, Florida, United States
Ocala Oncology Center, Ocala, Florida, United States
Cancer Centers of Florida, P.A., Ocoee, Florida, United States
Florida Oncology Associates, Orange Park, Florida, United States
Sacred Heart Medical Oncology, Pensacola, Florida, United States
Medical Oncology Associates of Augusta, Augusta, Georgia, United States
Joliet Oncology-Hematology Associates, Ltd., Joliet, Illinois, United States
Cancer & Hematology Specialists of Chicago (Main), Niles, Illinois, United States
Illinois Cancer Care, Peoria, Illinois, United States
Cancer Care at Blessing Hospital, Quincy, Illinois, United States
Central Indiana Cancer Centers, Indianapolis, Indiana, United States
Hope Center, Terre Haute, Indiana, United States
Kansas City Cancer Center (Main), Overland Park, Kansas, United States
Cancer Center of Kansas, Wichita, Kansas, United States
Jayne Gurtler MD, Laura Brizn MD, Angelo Russo MD, and Janet Burroff MD, APMC, Metairie, Louisiana, United States
Tulane University Health Sciences Center, New Orleans, Louisiana, United States
Maine Center for Cancer Medicine and Blood Disorders, Scarborough, Maine, United States
Sinai Hospital of Baltimore, Inc., Baltimore, Maryland, United States
Center for Cancer and Blood Disorders, Bethesda, Maryland, United States
Alliance Hematology Oncology, P.A. (Main), Westminster, Maryland, United States
Kalamazoo Hematology and Oncology, Kalamazoo, Michigan, United States
Michigan Hematology & Oncology Institute, Southgate, Michigan, United States
University of Minnesota Medical Center, Cancer Center, Minneapolis, Minnesota, United States
Missouri Cancer Associates, Columbia, Missouri, United States
St. Joseph Oncology, Inc., Saint Joseph, Missouri, United States
Comprehensive Care Centers of Nevada (Main), Las Vegas, Nevada, United States
New York Oncology Hematology, P.C., Latham, New York, United States
SUNY Upstate Medical University - Regional Oncology Center, Syracuse, New York, United States
Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
Regional Cancer Care, Durham, North Carolina, United States
Cancer Centers of North Carolina (Main), Raleigh, North Carolina, United States
Piedmont Hematology Oncology Associates, Winston-Salem, North Carolina, United States
Gabrail Cancer Center, Canton, Ohio, United States
Greater Dayton Cancer Center (Main), Kettering, Ohio, United States
Cancer Care Associates, Oklahoma City, Oklahoma, United States
Cancer Care Associates, Tulsa, Oklahoma, United States
Willamette Valley Cancer Center (Main), Eugene, Oregon, United States
Medical Oncology Associates, Kingston, Pennsylvania, United States
Thomas Jefferson Memorial Hospital, Philadelphia, Pennsylvania, United States
UPMC Cancer Pavilion, Pittsburgh, Pennsylvania, United States
Cancer Centers of the Carolinas (Main), Greenville, South Carolina, United States
The Sarah Cannon Research Institute/TN Oncology, Nashville, Tennessee, United States
Texas Oncology, P.A., Amarillo, Texas, United States
Coastal Bend Cancer Center, Corpus Christi, Texas, United States
Texas Cancer Center at Medical City (Main), Dallas, Texas, United States
Texas Oncology, P.A. (Main), Dallas, Texas, United States
West Texas Cancer Center-Texas Oncology, Odessa, Texas, United States
Texas Oncology, P.A., Webster, Texas, United States
Texoma Cancer Center, Wichita Falls, Texas, United States
Fairfax Northern Virginia Hematology/Oncology, Fairfax, Virginia, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Blue Ridge Cancer Care, Roanoke, Virginia, United States
Northwest Cancer Specialists - Vancouver (Main), Vancouver, Washington, United States
Marshfield Clinic, Marshfield, Wisconsin, United States
Royal North Shore Hospital, St. Leonards, New South Wales, Australia
New South Wales Southern Medical Day Care Centre, Wollongong, New South Wales, Australia
The Princess Alexandra Hospital, Dept of Respiratory Medicine, Woolloongabba, Queensland, Australia
Flinders Medical Centre, Bedford Park, South Australia, Australia
The Queen Elizabeth Hospital, Woodville South, , Australia
Allgemeines Krankenhaus der Stadt Linz, Abteilung fur Atem und Lungenkrankheiten, Linz, , Austria
Klinikum Weis-Grieskirchen GmbH, Wels, , Austria
Allegemeines Krankenhaus Wien, Univ. Klinik fur Innere, Medizin I, Wien, , Austria
Krankenhaus Hietzing, 5 Med. Abteilung mit Onkologie, Wien, , Austria
UZ Brussel, Medical Oncology and Hematology, Brussel, , Belgium
Centre Hospitalier Notre-Dame et Reine Fabiola, Charleroi, , Belgium
Universitair Ziekenhuis Antwerpen, Dept. Respiratory Diseases, Edegem, , Belgium
UZ Gasthuisberg, UZ Leuven, Leuven, , Belgium
C.H.U. Sart-Tilman, Liege, , Belgium
III-rd Internal Department, District Dispensary for Oncology diseases with stationary(DDOncDIU), Plovdiv, , Bulgaria
DDOncDIU Sofia District, Sofia, , Bulgaria
MHAT "Tsaritsa Yoanna", Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment "Sveta Marina", Varna, , Bulgaria
Fraser Valley Cancer Centre-Surrey Memorial Hospital, Surrey, British Columbia, Canada
London Regional Cancer Centre, London, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Humber River Regional Hospital, Weston, Ontario, Canada
Royal Victoria Hospital, Montreal, Quebec, Canada
Fakultni Nemocnice Ostrava, Ostrava-Poruba, , Czechia
Faculty Hospital Motol, Praha 5, , Czechia
Fakultní Thomayerova nemocnice s poliklinikou, Praha, , Czechia
Masarykova nemocnice v Ústí nad Labem, Ústí nad Labem, , Czechia
Rikshospitalet, Finsen Center, Copenhagen, , Denmark
Herlev Hospital, Onkologisk afdeling R, Herlev, , Denmark
Odense Universitetshospital,Onkologisk afdeling R, Odense C, , Denmark
Centre François Baclesse, Caen Cedex 5, , France
Hôpital de la Croix-Rousse, Lyon Cedex 04, , France
CHU Montpellier - Unité de Cancérologie Thoracique, Montpellier Cedex, , France
Institut Gustave Roussy, Villejuif, , France
Zentralklinik Bad Berka GmbH, Bad Berka, , Germany
Charité Universitätsmedizin Berlin, Berlin, , Germany
Universitätsklinikum Essen Innere Klinik und Poliklinik, Essen, , Germany
Asklepios Fachkliniken Muenchen Gauting, Gauting, , Germany
Krankenhaus Grosshansdorf, Zentrum fur Pneumologie und Thoraxchirurgie, Grosshansdorf, , Germany
Staedtisches Krankenhaus Martha-Maria Halle-Doelau, Halle (Saale), , Germany
Thoraxklinik am Universitätsklinikum Heidelberg AG, Heidelberg, , Germany
St. Vincentius-Kliniken Karlsruhe, Hamatologie, Med Onkologie und Immunologie, Karlsruhe, , Germany
Katholisches Klinikum Mainz, St. Hildegardis Krankenhaus, Mainz, , Germany
Klinikum Mannheim GmbH, Chirugische Klinik, Thorakale Onkologie, Mannheim, , Germany
Semmelweis University of Medicine, Budapest, , Hungary
Országos Korányi Tbc és Pulmonológiai Intézet, Budapest, , Hungary
DEODEC, Debrecen, , Hungary
Matrai Gyogyintezet, Matrahaza, , Hungary
County Hospital Baranya, Pecs, , Hungary
Erzsébet Hospital Sopron, Sopron, , Hungary
Policlinico di Modena - University of Modena & Reggio Emilia, Dept Oncology & Hematology, Modena, , Italy
Ospedale S. Maria della Misericordia, Perugia, , Italy
Azienda Ospedaliera San Camillo Forlanini, Roma, , Italy
Ospedale S.S. Trinita, Sora, , Italy
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis, Amsterdam, , Netherlands
VU University Medical Center Amsterdam, Amsterdam, , Netherlands
University Medical Center Groningen, Groningen, , Netherlands
Elkerliek Ziekenhuis, Locatie Helmond, Helmond, , Netherlands
Erasmus MC - Daniel den Hoed, Rotterdam, , Netherlands
Specjalistyczny Zespol Chorob Pluc i Gruzlicy w Bystrej, Bystra, , Poland
Akademickie Centrum Kliniczne, Gdansk, , Poland
Zespol nr 1 Szpitala im. St. Leszczynskiego, Katowice, , Poland
Klinika Nowotworow Ukladowych i Uogolnionych Centrum Onkologii, Instytut im. Marii Sklodowskiej-Curie, Kraków, , Poland
Centrum Onkologii Ziemi Lubelskiej, Lublin, , Poland
Wielkopolskie Centrum Pulmonologii i Tarakochirurgii Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii, Poznan, , Poland
Szpital Specjalistyczny w Prabutach, Prabuty, , Poland
Wojewódzki Szpital Chorób Pluc im Alojzego Pawelca w Wodzislawiu Slaskim, Wodzislaw Slaski, , Poland
Hospital Universitario Germans Trias i Pujol, Barcelona, , Spain
Duran i Reynals Institut Catala d'Oncologia, L'Hospitalet de Llobregat, , Spain
Fundación Jiménez Díaz. Universidad Autónoma de Madrid, Madrid, , Spain
Hospital Universitario Virgin de la Victoria, Malaga, , Spain
Hospital General Universitario de Valencia, Valencia, , Spain
Kantonsspital Aarau, Aarau, , Switzerland
Kantonsspital Graubünden, Chur, , Switzerland
Universitätsspital Zürich, Zurich, , Switzerland
Edinburgh Cancer Research Centre, Edinburgh, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Christie Hospital NHS Foundation Trust, Manchester, , United Kingdom
The Royal Marsden NHS Foundation Trust, Surrey, , United Kingdom
Contact Details
Name: Markus Renschler, M.D.
Affiliation: Celgene Corporation
Role: STUDY_DIRECTOR
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