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Small Cell Lung CancerPhase 3NCT00547651

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

A Phase 3 study testing Amrubicin and Topotecan in people with Small Cell Lung Cancer, run by Celgene at 140 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
Amrubicin and Topotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
637 participants
Where
140 sitesin 17 countries
Study dates
1 Sep 2007to 1 May 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

140 sites in 17 countries.

140 sites in 17 countries

United States61 sites

  • Texas Oncology, P.A.

    Amarillo, Texas, 79106

  • Medical Oncology Associates of Augusta

    Augusta, Georgia, 30809

  • University of Colorado Health Science Centre

    Aurora, Colorado, 80045

  • Sinai Hospital of Baltimore, Inc.

    Baltimore, Maryland, 21215

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • Coastal Bend Cancer Center

    Corpus Christi, Texas, 78463

  • Texas Cancer Center at Medical City (Main)

    Dallas, Texas, 75230-2510

  • Texas Oncology, P.A. (Main)

    Dallas, Texas, 75246

  • Rocky Mountain Cancer Center - Midtown (Main)

    Denver, Colorado, 80218

  • Regional Cancer Care

    Durham, North Carolina, 27704

  • Willamette Valley Cancer Center (Main)

    Eugene, Oregon, 97401-8122

  • Fairfax Northern Virginia Hematology/Oncology

    Fairfax, Virginia, 22031

  • Cancer Care Associates of Fresno Medical Group, Inc.

    Fresno, California, 93720

  • Cancer Centers of the Carolinas (Main)

    Greenville, South Carolina, 29615

  • Central Indiana Cancer Centers

    Indianapolis, Indiana, 46227

  • Joliet Oncology-Hematology Associates, Ltd.

    Joliet, Illinois, 60435

  • Kalamazoo Hematology and Oncology

    Kalamazoo, Michigan, 49048

  • Greater Dayton Cancer Center (Main)

    Kettering, Ohio, 45409

  • Medical Oncology Associates

    Kingston, Pennsylvania, 18704

  • Comprehensive Care Centers of Nevada (Main)

    Las Vegas, Nevada, 89169

  • New York Oncology Hematology, P.C.

    Latham, New York, 12110-0610

  • Little Rock Hematology Oncology Associates

    Little Rock, Arkansas, 72205

  • Cedars-Sinai Outpatient Cancer Center

    Los Angeles, California, 90048

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Jayne Gurtler MD, Laura Brizn MD, Angelo Russo MD, and Janet Burroff MD, APMC

    Metairie, Louisiana, 70006

  • Advanced Medical Specialties

    Miami, Florida, 33176

  • University of Minnesota Medical Center, Cancer Center

    Minneapolis, Minnesota, 55455

  • Northwest Alabama Cancer Center

    Muscle Shoals, Alabama, 35661

  • The Sarah Cannon Research Institute/TN Oncology

    Nashville, Tennessee, 37203

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • Cancer & Hematology Specialists of Chicago (Main)

    Niles, Illinois, 60714

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Ocala Oncology Center

    Ocala, Florida, 34474

  • Cancer Centers of Florida, P.A.

    Ocoee, Florida, 34761

  • West Texas Cancer Center-Texas Oncology

    Odessa, Texas, 79761

  • Cancer Care Associates

    Oklahoma City, Oklahoma, 73112

  • Florida Oncology Associates

    Orange Park, Florida, 32073

  • Kansas City Cancer Center (Main)

    Overland Park, Kansas, 66210

  • Sacred Heart Medical Oncology

    Pensacola, Florida, 32504

  • Illinois Cancer Care

    Peoria, Illinois, 61615

  • Thomas Jefferson Memorial Hospital

    Philadelphia, Pennsylvania, 19107

  • UPMC Cancer Pavilion

    Pittsburgh, Pennsylvania, 15232

  • Cancer Care at Blessing Hospital

    Quincy, Illinois, 62301

  • Cancer Centers of North Carolina (Main)

    Raleigh, North Carolina, 27607

  • Blue Ridge Cancer Care

    Roanoke, Virginia, 24019

  • St. Joseph Oncology, Inc.

    Saint Joseph, Missouri, 64507

  • Maine Center for Cancer Medicine and Blood Disorders

    Scarborough, Maine, 04074

  • Michigan Hematology & Oncology Institute

    Southgate, Michigan, 48195

  • SUNY Upstate Medical University - Regional Oncology Center

    Syracuse, New York, 13210

  • Hope Center

    Terre Haute, Indiana, 47802

  • Arizona Oncology Associates

    Tucson, Arizona, 85704

  • Cancer Care Associates

    Tulsa, Oklahoma, 74136

  • Northwest Cancer Specialists - Vancouver (Main)

    Vancouver, Washington, 98684

  • Texas Oncology, P.A.

    Webster, Texas, 77598-4420

  • Alliance Hematology Oncology, P.A. (Main)

    Westminster, Maryland, 21157

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

  • Texoma Cancer Center

    Wichita Falls, Texas, 76310

  • Piedmont Hematology Oncology Associates

    Winston-Salem, North Carolina, 27103

Other trials in United States

Germany10 sites

  • Zentralklinik Bad Berka GmbH

    Bad Berka

  • Charité Universitätsmedizin Berlin

    Berlin, 12200

  • Universitätsklinikum Essen Innere Klinik und Poliklinik

    Essen, 45122

  • Asklepios Fachkliniken Muenchen Gauting

    Gauting, 82131

  • Krankenhaus Grosshansdorf, Zentrum fur Pneumologie und Thoraxchirurgie

    Großhansdorf, 22927

  • Staedtisches Krankenhaus Martha-Maria Halle-Doelau

    Halle, 6120

  • Thoraxklinik am Universitätsklinikum Heidelberg AG

    Heidelberg, 69126

  • St. Vincentius-Kliniken Karlsruhe, Hamatologie, Med Onkologie und Immunologie

    Karlsruhe, 76137

  • Katholisches Klinikum Mainz, St. Hildegardis Krankenhaus

    Mainz, 55131

  • Klinikum Mannheim GmbH, Chirugische Klinik, Thorakale Onkologie

    Mannheim, 68167

Other trials in Germany

Poland8 sites

  • Specjalistyczny Zespol Chorob Pluc i Gruzlicy w Bystrej

    Bystra, 43-360

  • Akademickie Centrum Kliniczne

    Gdansk, 80-211

  • Zespol nr 1 Szpitala im. St. Leszczynskiego

    Katowice, 40-074

  • Klinika Nowotworow Ukladowych i Uogolnionych Centrum Onkologii, Instytut im. Marii Sklodowskiej-Curie

    Krakow, 31-115

  • Centrum Onkologii Ziemi Lubelskiej

    Lublin, 20-090

  • Wielkopolskie Centrum Pulmonologii i Tarakochirurgii Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii

    Poznan, 60-569

  • Szpital Specjalistyczny w Prabutach

    Prabuty, 82550

  • Wojewódzki Szpital Chorób Pluc im Alojzego Pawelca w Wodzislawiu Slaskim

    Wodzisław Śląski, 44-300

Other trials in Poland

Hungary6 sites

  • Semmelweis University of Medicine

    Budapest, 1125

  • Országos Korányi Tbc és Pulmonológiai Intézet

    Budapest, 1529

  • DEODEC

    Debrecen, 4032

  • Matrai Gyogyintezet

    Mátraháza, 3233

  • County Hospital Baranya

    Pécs, 7623

  • Erzsébet Hospital Sopron

    Sopron, 9400

Other trials in Hungary

Australia5 sites

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • New South Wales Southern Medical Day Care Centre

    Wollongong, New South Wales, 2500

  • The Queen Elizabeth Hospital

    Woodville South, SA 5011

  • The Princess Alexandra Hospital, Dept of Respiratory Medicine

    Woolloongabba, Queensland

Other trials in Australia

Belgium5 sites

  • UZ Brussel, Medical Oncology and Hematology

    Brussels, 1090

  • Centre Hospitalier Notre-Dame et Reine Fabiola

    Charleroi, 6000

  • Universitair Ziekenhuis Antwerpen, Dept. Respiratory Diseases

    Edegem, 2650

  • UZ Gasthuisberg, UZ Leuven

    Leuven, 3000

  • C.H.U. Sart-Tilman

    Liège, 4000

Other trials in Belgium

Canada5 sites

  • London Regional Cancer Centre

    London, Ontario

  • Royal Victoria Hospital

    Montreal, Quebec, H3A 1A1

  • Fraser Valley Cancer Centre-Surrey Memorial Hospital

    Surrey, British Columbia

  • Princess Margaret Hospital

    Toronto, Ontario

  • Humber River Regional Hospital

    Weston, Ontario

Other trials in Canada

Netherlands5 sites

  • Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis

    Amsterdam, 1066 CX

  • VU University Medical Center Amsterdam

    Amsterdam, 1081 HV

  • University Medical Center Groningen

    Groningen, 9700 RB

  • Elkerliek Ziekenhuis, Locatie Helmond

    Helmond, 5700 AB

  • Erasmus MC - Daniel den Hoed

    Rotterdam, 3075 EA

Other trials in Netherlands

Spain5 sites

  • Hospital Universitario Germans Trias i Pujol

    Barcelona, 08916

  • Duran i Reynals Institut Catala d'Oncologia

    L'Hospitalet de Llobregat, 08907

  • Fundación Jiménez Díaz. Universidad Autónoma de Madrid

    Madrid, 28040

  • Hospital Universitario Virgin de la Victoria

    Málaga, 29010

  • Hospital General Universitario de Valencia

    Valencia, 46014

Other trials in Spain

Austria4 sites

  • Allgemeines Krankenhaus der Stadt Linz, Abteilung fur Atem und Lungenkrankheiten

    Linz, 4020

  • Allegemeines Krankenhaus Wien, Univ. Klinik fur Innere, Medizin I

    Vienna, 1090

  • Krankenhaus Hietzing, 5 Med. Abteilung mit Onkologie

    Vienna, 1130

  • Klinikum Weis-Grieskirchen GmbH

    Wels, 4600

Other trials in Austria

Bulgaria4 sites

  • III-rd Internal Department, District Dispensary for Oncology diseases with stationary(DDOncDIU)

    Plovdiv, 4004

  • DDOncDIU Sofia District

    Sofia, 1233

  • MHAT "Tsaritsa Yoanna"

    Sofia, 1504

  • University Multiprofile Hospital for Active Treatment "Sveta Marina"

    Varna, 9010

Other trials in Bulgaria

Czechia4 sites

  • Fakultni Nemocnice Ostrava

    Ostrava-Poruba

  • Fakultní Thomayerova nemocnice s poliklinikou

    Prague, 140 59

  • Faculty Hospital Motol

    Prague, 15006

  • Masarykova nemocnice v Ústí nad Labem

    Ústí nad Labem, 401 13

Other trials in Czechia

France4 sites

  • Centre François Baclesse

    Caen, 14076

  • Hôpital de la Croix-Rousse

    Lyon, 69317

  • CHU Montpellier - Unité de Cancérologie Thoracique

    Montpellier, 34295

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Italy4 sites

  • Policlinico di Modena - University of Modena & Reggio Emilia, Dept Oncology & Hematology

    Modena, 41100

  • Ospedale S. Maria della Misericordia

    Perugia, 06132

  • Azienda Ospedaliera San Camillo Forlanini

    Roma, 00151

  • Ospedale S.S. Trinita

    Sora, 03039

Other trials in Italy

United Kingdom4 sites

  • Edinburgh Cancer Research Centre

    Edinburgh

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • Christie Hospital NHS Foundation Trust

    Manchester, M20 4BX

  • The Royal Marsden NHS Foundation Trust

    Surrey, SM2 5PT

Other trials in United Kingdom

Denmark3 sites

  • Rikshospitalet, Finsen Center

    Copenhagen, 2100

  • Herlev Hospital, Onkologisk afdeling R

    Herlev, 2730

  • Odense Universitetshospital,Onkologisk afdeling R

    Odense C, 5000

Other trials in Denmark

Switzerland3 sites

  • Kantonsspital Aarau

    Aarau, 5011

  • Kantonsspital Graubünden

    Chur, 7000

  • Universitätsspital Zürich

    Zurich, 8091

Other trials in Switzerland

About this study

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

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.

Read the 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.

Being tested
Amrubicin, Topotecan
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
Medical subject headings
Small Cell Lung Carcinoma, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmrubicinDrug

    Also called amrubidin hydrochloride, Calsed, CNF3140

    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

  • TopotecanDrug

    Also called Topotecan hydrochloride, Hycamtin

    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

Study groups in NCT00547651
Study groupRoleWhat they receive
AmrubicinExperimentalAmrubicin
Receives: Drug: Amrubicin
TopotecanActive comparatorTopotecan
Receives: Drug: Topotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Until death from any cause

Secondary outcomes (6)

  1. To further characterize the clinical benefit of amrubicin compared with topotecan in terms of objective response rate

    Measured: Until death

  2. To further characterize the clinical benefit of amrubicin compared with topotecan in terms of progression-free survival.

    Measured: Until death

  3. To further characterize the clinical benefit of amrubicin compared with topotecan in terms of duration of response

    Measured: Until death

  4. To further characterize the clinical benefit of amrubicin compared with topotecan in terms of time to tumor progression

    Measured: Until death

  5. To further characterize the clinical benefit of amrubicin compared with topotecan in terms of safety

    Measured: Until death

  6. To further characterize the clinical benefit of amrubicin compared with topotecan in terms of quality of life

    Measured: Until death

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2007 (estimated)
  2. Study start1 Sep 2007
  3. Primary completion1 May 2011
  4. Study completion1 May 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
637 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00547651
Sponsor's protocol ID
AMR PH GL 2007 CL001
Status last verified
Oct 2019
First submitted
18 Oct 2007
Last updated
6 Nov 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25385727

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Amrubicin and Topotecan in people with Small Cell Lung Cancer, run by Celgene at 140 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 140 sites in United States, Germany, Poland, Hungary, Australia and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: Until death from any cause). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00547651, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2019.

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