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AMR PH GL 2007 CL001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00547651
First received: October 18, 2007
Last updated: March 26, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Small Cell Lung Cancer
Drug: Amrubicin
Drug: Topotecan
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • 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. [ Time Frame: Until death from any cause ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To further characterize the clinical benefit of amrubicin compared with topotecan in terms of objective response rate [ Time Frame: Until death ] [ Designated as safety issue: No ]
  • To further characterize the clinical benefit of amrubicin compared with topotecan in terms of progression-free survival. [ Time Frame: Until death ] [ Designated as safety issue: No ]
  • To further characterize the clinical benefit of amrubicin compared with topotecan in terms of duration of response [ Time Frame: Until death ] [ Designated as safety issue: No ]
  • To further characterize the clinical benefit of amrubicin compared with topotecan in terms of time to tumor progression [ Time Frame: Until death ] [ Designated as safety issue: No ]
  • To further characterize the clinical benefit of amrubicin compared with topotecan in terms of safety [ Time Frame: Until death ] [ Designated as safety issue: Yes ]
  • To further characterize the clinical benefit of amrubicin compared with topotecan in terms of quality of life [ Time Frame: Until death ] [ Designated as safety issue: No ]

Enrollment: 637
Study Start Date: September 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Amrubicin
Amrubicin
Drug: 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
Other Name: amrubidin hydrochloride, Calsed, CNF3140
Active Comparator: Topotecan
Topotecan
Drug: 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 Name: Topotecan hydrochloride, Hycamtin

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547651

  Hide Study Locations
Locations
United States, Alabama
Northwest Alabama Cancer Center
Muscle Shoals, Alabama, United States, 35661
United States, Arizona
Arizona Oncology Associates
Tucson, Arizona, United States, 85704
United States, Arkansas
Little Rock Hematology Oncology Associates
Little Rock, Arkansas, United States, 72205
United States, California
Cancer Care Associates of Fresno Medical Group, Inc.
Fresno, California, United States, 93720
Cedars-Sinai Outpatient Cancer Center
Los Angeles, California, United States, 90048
United States, Colorado
University of Colorado Health Science Centre
Aurora, Colorado, United States, 80045
Rocky Mountain Cancer Center - Midtown (Main)
Denver, Colorado, United States, 80218
United States, Florida
Advanced Medical Specialties
Miami, Florida, United States, 33176
Ocala Oncology Center
Ocala, Florida, United States, 34474
Cancer Centers of Florida, P.A.
Ocoee, Florida, United States, 34761
Florida Oncology Associates
Orange Park, Florida, United States, 32073
Sacred Heart Medical Oncology
Pensacola, Florida, United States, 32504
United States, Georgia
Medical Oncology Associates of Augusta
Augusta, Georgia, United States, 30809
United States, Illinois
Joliet Oncology-Hematology Associates, Ltd.
Joliet, Illinois, United States, 60435
Cancer & Hematology Specialists of Chicago (Main)
Niles, Illinois, United States, 60714
Illinois Cancer Care
Peoria, Illinois, United States, 61615
Cancer Care at Blessing Hospital
Quincy, Illinois, United States, 62301
United States, Indiana
Central Indiana Cancer Centers
Indianapolis, Indiana, United States, 46227
Hope Center
Terre Haute, Indiana, United States, 47802
United States, Kansas
Kansas City Cancer Center (Main)
Overland Park, Kansas, United States, 66210
Cancer Center of Kansas
Wichita, Kansas, United States, 67214
United States, Louisiana
Jayne Gurtler MD, Laura Brizn MD, Angelo Russo MD, and Janet Burroff MD, APMC
Metairie, Louisiana, United States, 70006
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Maine
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, United States, 04074
United States, Maryland
Sinai Hospital of Baltimore, Inc.
Baltimore, Maryland, United States, 21215
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
Alliance Hematology Oncology, P.A. (Main)
Westminster, Maryland, United States, 21157
United States, Michigan
Kalamazoo Hematology and Oncology
Kalamazoo, Michigan, United States, 49048
Michigan Hematology & Oncology Institute
Southgate, Michigan, United States, 48195
United States, Minnesota
University of Minnesota Medical Center, Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Missouri Cancer Associates
Columbia, Missouri, United States, 65201
St. Joseph Oncology, Inc.
St. Joseph, Missouri, United States, 64507
United States, Nevada
Comprehensive Care Centers of Nevada (Main)
Las Vegas, Nevada, United States, 89169
United States, New York
New York Oncology Hematology, P.C.
Latham, New York, United States, 12110-0610
SUNY Upstate Medical University - Regional Oncology Center
Syracuse, New York, United States, 13210
United States, North Carolina
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Regional Cancer Care
Durham, North Carolina, United States, 27704
Cancer Centers of North Carolina (Main)
Raleigh, North Carolina, United States, 27607
Piedmont Hematology Oncology Associates
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Greater Dayton Cancer Center (Main)
Kettering, Ohio, United States, 45409
United States, Oklahoma
Cancer Care Associates
Oklahoma City, Oklahoma, United States, 73112
Cancer Care Associates
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Willamette Valley Cancer Center (Main)
Eugene, Oregon, United States, 97401-8122
United States, Pennsylvania
Medical Oncology Associates
Kingston, Pennsylvania, United States, 18704
Thomas Jefferson Memorial Hospital
Philadelphia, Pennsylvania, United States, 19107
UPMC Cancer Pavilion
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Cancer Centers of the Carolinas (Main)
Greenville, South Carolina, United States, 29615
United States, Tennessee
The Sarah Cannon Research Institute/TN Oncology
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Oncology, P.A.
Amarillo, Texas, United States, 79106
Coastal Bend Cancer Center
Corpus Christi, Texas, United States, 78463
Texas Cancer Center at Medical City (Main)
Dallas, Texas, United States, 75230-2510
Texas Oncology, P.A. (Main)
Dallas, Texas, United States, 75246
West Texas Cancer Center-Texas Oncology
Odessa, Texas, United States, 79761
Texas Oncology, P.A.
Webster, Texas, United States, 77598-4420
Texoma Cancer Center
Wichita Falls, Texas, United States, 76310
United States, Virginia
Fairfax Northern Virginia Hematology/Oncology
Fairfax, Virginia, United States, 22031
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Blue Ridge Cancer Care
Roanoke, Virginia, United States, 24019
United States, Washington
Northwest Cancer Specialists - Vancouver (Main)
Vancouver, Washington, United States, 98684
United States, Wisconsin
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Australia, New South Wales
Royal North Shore Hospital
St. Leonards, New South Wales, Australia, 2065
New South Wales Southern Medical Day Care Centre
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
The Princess Alexandra Hospital, Dept of Respiratory Medicine
Woolloongabba, Queensland, Australia
Australia, South Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Australia
The Queen Elizabeth Hospital
Woodville South, Australia, SA 5011
Austria
Allgemeines Krankenhaus der Stadt Linz, Abteilung fur Atem und Lungenkrankheiten
Linz, Austria, 4020
Klinikum Weis-Grieskirchen GmbH
Wels, Austria, 4600
Allegemeines Krankenhaus Wien, Univ. Klinik fur Innere, Medizin I
Wien, Austria, 1090
Krankenhaus Hietzing, 5 Med. Abteilung mit Onkologie
Wien, Austria, 1130
Belgium
UZ Brussel, Medical Oncology and Hematology
Brussel, Belgium, 1090
Centre Hospitalier Notre-Dame et Reine Fabiola
Charleroi, Belgium, 6000
Universitair Ziekenhuis Antwerpen, Dept. Respiratory Diseases
Edegem, Belgium, 2650
UZ Gasthuisberg, UZ Leuven
Leuven, Belgium, 3000
C.H.U. Sart-Tilman
Liege, Belgium, 4000
Bulgaria
III-rd Internal Department, District Dispensary for Oncology diseases with stationary(DDOncDIU)
Plovdiv, Bulgaria, 4004
DDOncDIU Sofia District
Sofia, Bulgaria, 1233
MHAT "Tsaritsa Yoanna"
Sofia, Bulgaria, 1504
University Multiprofile Hospital for Active Treatment "Sveta Marina"
Varna, Bulgaria, 9010
Canada, British Columbia
Fraser Valley Cancer Centre-Surrey Memorial Hospital
Surrey, British Columbia, Canada
Canada, Ontario
London Regional Cancer Centre
London, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Humber River Regional Hospital
Weston, Ontario, Canada
Canada, Quebec
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
Czech Republic
Fakultni Nemocnice Ostrava
Ostrava-Poruba, Czech Republic
Fakultní Thomayerova nemocnice s poliklinikou
Praha, Czech Republic, 140 59
Faculty Hospital Motol
Praha 5, Czech Republic, 15006
Masarykova nemocnice v Ústí nad Labem
Ústí nad Labem, Czech Republic, 401 13
Denmark
Rikshospitalet, Finsen Center
Copenhagen, Denmark, 2100
Herlev Hospital, Onkologisk afdeling R
Herlev, Denmark, 2730
Odense Universitetshospital,Onkologisk afdeling R
Odense C, Denmark, 5000
France
Centre François Baclesse
Caen Cedex 5, France, 14076
Hôpital de la Croix-Rousse
Lyon Cedex 04, France, 69317
CHU Montpellier - Unité de Cancérologie Thoracique
Montpellier Cedex, France, 34295
Institut Gustave Roussy
Villejuif, France, 94805
Germany
Zentralklinik Bad Berka GmbH
Bad Berka, Germany
Charité Universitätsmedizin Berlin
Berlin, Germany, 12200
Universitätsklinikum Essen Innere Klinik und Poliklinik
Essen, Germany, 45122
Asklepios Fachkliniken Muenchen Gauting
Gauting, Germany, 82131
Krankenhaus Grosshansdorf, Zentrum fur Pneumologie und Thoraxchirurgie
Grosshansdorf, Germany, 22927
Staedtisches Krankenhaus Martha-Maria Halle-Doelau
Halle (Saale), Germany, 6120
Thoraxklinik am Universitätsklinikum Heidelberg AG
Heidelberg, Germany, 69126
St. Vincentius-Kliniken Karlsruhe, Hamatologie, Med Onkologie und Immunologie
Karlsruhe, Germany, 76137
Katholisches Klinikum Mainz, St. Hildegardis Krankenhaus
Mainz, Germany, 55131
Klinikum Mannheim GmbH, Chirugische Klinik, Thorakale Onkologie
Mannheim, Germany, 68167
Hungary
Országos Korányi Tbc és Pulmonológiai Intézet
Budapest, Hungary, 1529
Semmelweis University of Medicine
Budapest, Hungary, 1125
DEODEC
Debrecen, Hungary, 4032
Matrai Gyogyintezet
Matrahaza, Hungary, 3233
County Hospital Baranya
Pecs, Hungary, 7623
Erzsébet Hospital Sopron
Sopron, Hungary, 9400
Italy
Policlinico di Modena - University of Modena & Reggio Emilia, Dept Oncology & Hematology
Modena, Italy, 41100
Ospedale S. Maria della Misericordia
Perugia, Italy, 06132
Azienda Ospedaliera San Camillo Forlanini
Roma, Italy, 00151
Ospedale S.S. Trinita
Sora, Italy, 03039
Netherlands
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis
Amsterdam, Netherlands, 1066 CX
VU University Medical Center Amsterdam
Amsterdam, Netherlands, 1081 HV
University Medical Center Groningen
Groningen, Netherlands, 9700 RB
Elkerliek Ziekenhuis, Locatie Helmond
Helmond, Netherlands, 5700 AB
Erasmus MC - Daniel den Hoed
Rotterdam, Netherlands, 3075 EA
Poland
Specjalistyczny Zespol Chorob Pluc i Gruzlicy w Bystrej
Bystra, Poland, 43-360
Akademickie Centrum Kliniczne
Gdansk, Poland, 80-211
Zespol nr 1 Szpitala im. St. Leszczynskiego
Katowice, Poland, 40-074
Klinika Nowotworow Ukladowych i Uogolnionych Centrum Onkologii, Instytut im. Marii Sklodowskiej-Curie
Kraków, Poland, 31-115
Centrum Onkologii Ziemi Lubelskiej
Lublin, Poland, 20-090
Wielkopolskie Centrum Pulmonologii i Tarakochirurgii Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
Poznan, Poland, 60-569
Szpital Specjalistyczny w Prabutach
Prabuty, Poland, 82550
Wojewódzki Szpital Chorób Pluc im Alojzego Pawelca w Wodzislawiu Slaskim
Wodzislaw Slaski, Poland, 44-300
Spain
Hospital Universitario Germans Trias i Pujol
Barcelona, Spain, 08916
Duran i Reynals Institut Catala d'Oncologia
L'Hospitalet de Llobregat, Spain, 08907
Fundación Jiménez Díaz. Universidad Autónoma de Madrid
Madrid, Spain, 28040
Hospital Universitario Virgin de la Victoria
Malaga, Spain, 29010
Hospital General Universitario de Valencia
Valencia, Spain, 46014
Switzerland
Kantonsspital Aarau
Aarau, Switzerland, 5011
Kantonsspital Graubünden
Chur, Switzerland, 7000
Universitätsspital Zürich
Zurich, Switzerland, 8091
United Kingdom
Edinburgh Cancer Research Centre
Edinburgh, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Christie Hospital NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
The Royal Marsden NHS Foundation Trust
Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Markus Renschler, M.D. Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00547651     History of Changes
Other Study ID Numbers: AMR PH GL 2007 CL001
Study First Received: October 18, 2007
Last Updated: March 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
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

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Amrubicin
Topotecan
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 27, 2014