AMR PH GL 2007 CL001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy
NCT ID: NCT00547651
Last Updated: 2019-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
637 participants
INTERVENTIONAL
2007-09-01
2011-05-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Amrubicin
Amrubicin
Amrubicin
Amrubicin for injection is supplied as 50-mg vials. Patients will receive 40 mg/m2 amrubicin as a 5-minute infusion once daily for 3 consecutive days starting on Day 1 of a 21-day course
Topotecan
Topotecan
Topotecan
Topotecan for injection is supplied as 4-mg vials. Patients will receive 1.5 mg/m2 as a 30-minute infusion once daily for 5 consecutive days starting on Day 1 of a 21-day course
Interventions
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Amrubicin
Amrubicin for injection is supplied as 50-mg vials. Patients will receive 40 mg/m2 amrubicin as a 5-minute infusion once daily for 3 consecutive days starting on Day 1 of a 21-day course
Topotecan
Topotecan for injection is supplied as 4-mg vials. Patients will receive 1.5 mg/m2 as a 30-minute infusion once daily for 5 consecutive days starting on Day 1 of a 21-day course
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* SCLC that is either sensitive (defined as a response including stable disease to first-line platinum-based chemotherapy, with subsequent progression \>/= 90 days after completing first-line chemotherapy) or refractory (defined as best response to first-line platinum-based chemotherapy or progression \< 90 days after completing first-line chemotherapy);
* Extensive or limited disease; patients with limited disease who are candidates for local or regional salvage radiation therapy must have been offered such treatment prior to participation in this study;
* Radiographically documented progression after first-line treatment with platinum-based chemotherapy;
* No more than 1 prior chemotherapy regimen;
* At least 18 years of age;
* ECOG performance status of 0 - 1
Exclusion Criteria
* Prior anthracycline, topotecan, or irinotecan treatment.
* Prior anthracycline or topotecan treatment.
* Patients with know history of seropositive human immunodeficiency virus (HIV) or patients who are receiving immunosuppressive medications that would increase the risk of serious neutropenic complications
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Markus Renschler, M.D.
Role: STUDY_DIRECTOR
Celgene Corporation
Locations
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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
Allegemeines Krankenhaus Wien, Univ. Klinik fur Innere, Medizin I
Vienna, , Austria
Krankenhaus Hietzing, 5 Med. Abteilung mit Onkologie
Vienna, , Austria
Klinikum Weis-Grieskirchen GmbH
Wels, , Austria
UZ Brussel, Medical Oncology and Hematology
Brussels, , 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
Liège, , 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
Fakultní Thomayerova nemocnice s poliklinikou
Prague, , Czechia
Faculty Hospital Motol
Prague, , 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, , France
Hôpital de la Croix-Rousse
Lyon, , France
CHU Montpellier - Unité de Cancérologie Thoracique
Montpellier, , 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, , 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
Mátraháza, , Hungary
County Hospital Baranya
Pécs, , 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
Krakow, , 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
Wodzisław Śląski, , 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
Málaga, , 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
Countries
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References
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von Pawel J, Jotte R, Spigel DR, O'Brien ME, Socinski MA, Mezger J, Steins M, Bosquee L, Bubis J, Nackaerts K, Trigo JM, Clingan P, Schutte W, Lorigan P, Reck M, Domine M, Shepherd FA, Li S, Renschler MF. Randomized phase III trial of amrubicin versus topotecan as second-line treatment for patients with small-cell lung cancer. J Clin Oncol. 2014 Dec 10;32(35):4012-9. doi: 10.1200/JCO.2013.54.5392. Epub 2014 Nov 10.
Other Identifiers
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AMR PH GL 2007 CL001
Identifier Type: -
Identifier Source: org_study_id
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