Clinical trial NCT00547651: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Small Cell Lung Cancer
Keywords: Small Cell Lung Cancer
Lung Cancer
Limited Disease Sensitive Small Cell Lung Cancer
Extensive Disease Sensitive Small Cell Lung Cancer
Limited Disease Refractory Small Cell Lung Cancer
Extensive Disease Refractory Small Cell Lung Cancer
Refractory Small Cell Lung Cancer
Sensitive Small Cell Lung Cancer
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2007-10-22
Enrollment: 637
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Histological or cytological diagnosis of SCLC at study entry according to the International Association for the Study of Lung Cancer (IASLC) histopathologic classification. Mixed or combined subtypes according to the IASLC are not allowed;
* 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:

* Chest radiotherapy with curative intent to the primary disease complex \</= 28 days prior to first dose; CNS radiotherapy \</= 21 days prior to first dose; radiotherapy to all other areas \</= 7 days prior to first dose;
* 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

Primary outcomes:
measure: The primary objective is to demonstrate superiority in overall survival of amrubicin compared with topotecan hydrochloride in patients with small cell lung cancer (SCLC) after failure of first-line chemotherapy.
timeFrame: Until death from any cause
Secondary outcomes:
measure: To further characterize the clinical benefit of amrubicin compared with topotecan in terms of objective response rate
timeFrame: Until death
measure: To further characterize the clinical benefit of amrubicin compared with topotecan in terms of progression-free survival.
timeFrame: Until death
measure: To further characterize the clinical benefit of amrubicin compared with topotecan in terms of duration of response
timeFrame: Until death
measure: To further characterize the clinical benefit of amrubicin compared with topotecan in terms of time to tumor progression
timeFrame: Until death
measure: To further characterize the clinical benefit of amrubicin compared with topotecan in terms of safety
timeFrame: Until death
measure: To further characterize the clinical benefit of amrubicin compared with topotecan in terms of quality of life
timeFrame: Until death
Other outcomes:
Locations:
city: Muscle Shoals
country: United States
facility: Northwest Alabama Cancer Center
state: Alabama
city: Tucson
country: United States
facility: Arizona Oncology Associates
state: Arizona
city: Little Rock
country: United States
facility: Little Rock Hematology Oncology Associates
state: Arkansas
city: Fresno
country: United States
facility: Cancer Care Associates of Fresno Medical Group, Inc.
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Outpatient Cancer Center
state: California
city: Aurora
country: United States
facility: University of Colorado Health Science Centre
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Center - Midtown (Main)
state: Colorado
city: Miami
country: United States
facility: Advanced Medical Specialties
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Ocoee
country: United States
facility: Cancer Centers of Florida, P.A.
state: Florida
city: Orange Park
country: United States
facility: Florida Oncology Associates
state: Florida
city: Pensacola
country: United States
facility: Sacred Heart Medical Oncology
state: Florida
city: Augusta
country: United States
facility: Medical Oncology Associates of Augusta
state: Georgia
city: Joliet
country: United States
facility: Joliet Oncology-Hematology Associates, Ltd.
state: Illinois
city: Niles
country: United States
facility: Cancer & Hematology Specialists of Chicago (Main)
state: Illinois
city: Peoria
country: United States
facility: Illinois Cancer Care
state: Illinois
city: Quincy
country: United States
facility: Cancer Care at Blessing Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Central Indiana Cancer Centers
state: Indiana
city: Terre Haute
country: United States
facility: Hope Center
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Cancer Center (Main)
state: Kansas
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Metairie
country: United States
facility: Jayne Gurtler MD, Laura Brizn MD, Angelo Russo MD, and Janet Burroff MD, APMC
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: Scarborough
country: United States
facility: Maine Center for Cancer Medicine and Blood Disorders
state: Maine
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore, Inc.
state: Maryland
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders
state: Maryland
city: Westminster
country: United States
facility: Alliance Hematology Oncology, P.A. (Main)
state: Maryland
city: Kalamazoo
country: United States
facility: Kalamazoo Hematology and Oncology
state: Michigan
city: Southgate
country: United States
facility: Michigan Hematology & Oncology Institute
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center, Cancer Center
state: Minnesota
city: Columbia
country: United States
facility: Missouri Cancer Associates
state: Missouri
city: Saint Joseph
country: United States
facility: St. Joseph Oncology, Inc.
state: Missouri
city: Las Vegas
country: United States
facility: Comprehensive Care Centers of Nevada (Main)
state: Nevada
city: Latham
country: United States
facility: New York Oncology Hematology, P.C.
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University - Regional Oncology Center
state: New York
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center
state: North Carolina
city: Durham
country: United States
facility: Regional Cancer Care
state: North Carolina
city: Raleigh
country: United States
facility: Cancer Centers of North Carolina (Main)
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Hematology Oncology Associates
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Kettering
country: United States
facility: Greater Dayton Cancer Center (Main)
state: Ohio
city: Oklahoma City
country: United States
facility: Cancer Care Associates
state: Oklahoma
city: Tulsa
country: United States
facility: Cancer Care Associates
state: Oklahoma
city: Eugene
country: United States
facility: Willamette Valley Cancer Center (Main)
state: Oregon
city: Kingston
country: United States
facility: Medical Oncology Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson Memorial Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Cancer Pavilion
state: Pennsylvania
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas (Main)
state: South Carolina
city: Nashville
country: United States
facility: The Sarah Cannon Research Institute/TN Oncology
state: Tennessee
city: Amarillo
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Corpus Christi
country: United States
facility: Coastal Bend Cancer Center
state: Texas
city: Dallas
country: United States
facility: Texas Cancer Center at Medical City (Main)
state: Texas
city: Dallas
country: United States
facility: Texas Oncology, P.A. (Main)
state: Texas
city: Odessa
country: United States
facility: West Texas Cancer Center-Texas Oncology
state: Texas
city: Webster
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Wichita Falls
country: United States
facility: Texoma Cancer Center
state: Texas
city: Fairfax
country: United States
facility: Fairfax Northern Virginia Hematology/Oncology
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Roanoke
country: United States
facility: Blue Ridge Cancer Care
state: Virginia
city: Vancouver
country: United States
facility: Northwest Cancer Specialists - Vancouver (Main)
state: Washington
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
city: St. Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Wollongong
country: Australia
facility: New South Wales Southern Medical Day Care Centre
state: New South Wales
city: Woolloongabba
country: Australia
facility: The Princess Alexandra Hospital, Dept of Respiratory Medicine
state: Queensland
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital
city: Linz
country: Austria
facility: Allgemeines Krankenhaus der Stadt Linz, Abteilung fur Atem und Lungenkrankheiten
city: Wels
country: Austria
facility: Klinikum Weis-Grieskirchen GmbH
city: Wien
country: Austria
facility: Allegemeines Krankenhaus Wien, Univ. Klinik fur Innere, Medizin I
city: Wien
country: Austria
facility: Krankenhaus Hietzing, 5 Med. Abteilung mit Onkologie
city: Brussel
country: Belgium
facility: UZ Brussel, Medical Oncology and Hematology
city: Charleroi
country: Belgium
facility: Centre Hospitalier Notre-Dame et Reine Fabiola
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen, Dept. Respiratory Diseases
city: Leuven
country: Belgium
facility: UZ Gasthuisberg, UZ Leuven
city: Liege
country: Belgium
facility: C.H.U. Sart-Tilman
city: Plovdiv
country: Bulgaria
facility: III-rd Internal Department, District Dispensary for Oncology diseases with stationary(DDOncDIU)
city: Sofia
country: Bulgaria
facility: DDOncDIU Sofia District
city: Sofia
country: Bulgaria
facility: MHAT "Tsaritsa Yoanna"
city: Varna
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment "Sveta Marina"
city: Surrey
country: Canada
facility: Fraser Valley Cancer Centre-Surrey Memorial Hospital
state: British Columbia
city: London
country: Canada
facility: London Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Weston
country: Canada
facility: Humber River Regional Hospital
state: Ontario
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
city: Ostrava-Poruba
country: Czechia
facility: Fakultni Nemocnice Ostrava
city: Praha 5
country: Czechia
facility: Faculty Hospital Motol
city: Praha
country: Czechia
facility: Fakultní Thomayerova nemocnice s poliklinikou
city: Ústí nad Labem
country: Czechia
facility: Masarykova nemocnice v Ústí nad Labem
city: Copenhagen
country: Denmark
facility: Rikshospitalet, Finsen Center
city: Herlev
country: Denmark
facility: Herlev Hospital, Onkologisk afdeling R
city: Odense C
country: Denmark
facility: Odense Universitetshospital,Onkologisk afdeling R
city: Caen Cedex 5
country: France
facility: Centre François Baclesse
city: Lyon Cedex 04
country: France
facility: Hôpital de la Croix-Rousse
city: Montpellier Cedex
country: France
facility: CHU Montpellier - Unité de Cancérologie Thoracique
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Essen
country: Germany
facility: Universitätsklinikum Essen Innere Klinik und Poliklinik
city: Gauting
country: Germany
facility: Asklepios Fachkliniken Muenchen Gauting
city: Grosshansdorf
country: Germany
facility: Krankenhaus Grosshansdorf, Zentrum fur Pneumologie und Thoraxchirurgie
city: Halle (Saale)
country: Germany
facility: Staedtisches Krankenhaus Martha-Maria Halle-Doelau
city: Heidelberg
country: Germany
facility: Thoraxklinik am Universitätsklinikum Heidelberg AG
city: Karlsruhe
country: Germany
facility: St. Vincentius-Kliniken Karlsruhe, Hamatologie, Med Onkologie und Immunologie
city: Mainz
country: Germany
facility: Katholisches Klinikum Mainz, St. Hildegardis Krankenhaus
city: Mannheim
country: Germany
facility: Klinikum Mannheim GmbH, Chirugische Klinik, Thorakale Onkologie
city: Budapest
country: Hungary
facility: Semmelweis University of Medicine
city: Budapest
country: Hungary
facility: Országos Korányi Tbc és Pulmonológiai Intézet
city: Debrecen
country: Hungary
facility: DEODEC
city: Matrahaza
country: Hungary
facility: Matrai Gyogyintezet
city: Pecs
country: Hungary
facility: County Hospital Baranya
city: Sopron
country: Hungary
facility: Erzsébet Hospital Sopron
city: Modena
country: Italy
facility: Policlinico di Modena - University of Modena & Reggio Emilia, Dept Oncology & Hematology
city: Perugia
country: Italy
facility: Ospedale S. Maria della Misericordia
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
city: Sora
country: Italy
facility: Ospedale S.S. Trinita
city: Amsterdam
country: Netherlands
facility: Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis
city: Amsterdam
country: Netherlands
facility: VU University Medical Center Amsterdam
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Helmond
country: Netherlands
facility: Elkerliek Ziekenhuis, Locatie Helmond
city: Rotterdam
country: Netherlands
facility: Erasmus MC - Daniel den Hoed
city: Bystra
country: Poland
facility: Specjalistyczny Zespol Chorob Pluc i Gruzlicy w Bystrej
city: Gdansk
country: Poland
facility: Akademickie Centrum Kliniczne
city: Katowice
country: Poland
facility: Zespol nr 1 Szpitala im. St. Leszczynskiego
city: Kraków
country: Poland
facility: Klinika Nowotworow Ukladowych i Uogolnionych Centrum Onkologii, Instytut im. Marii Sklodowskiej-Curie
city: Lublin
country: Poland
facility: Centrum Onkologii Ziemi Lubelskiej
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Pulmonologii i Tarakochirurgii Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
city: Prabuty
country: Poland
facility: Szpital Specjalistyczny w Prabutach
city: Wodzislaw Slaski
country: Poland
facility: Wojewódzki Szpital Chorób Pluc im Alojzego Pawelca w Wodzislawiu Slaskim
city: Barcelona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
city: L'Hospitalet de Llobregat
country: Spain
facility: Duran i Reynals Institut Catala d'Oncologia
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz. Universidad Autónoma de Madrid
city: Malaga
country: Spain
facility: Hospital Universitario Virgin de la Victoria
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden
city: Zurich
country: Switzerland
facility: Universitätsspital Zürich
city: Edinburgh
country: United Kingdom
facility: Edinburgh Cancer Research Centre
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Foundation Trust
city: Surrey
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
Study officials:
affiliation: Celgene Corporation
name: Markus Renschler, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.