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Drug Information from MedlinePlus
AMR PH GL 2007 CL 001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III


Treatment


Active


18 and over


Pharmaceutical / Industry


AMR PH GL 2007 CL 001
NCT00547651

Trial Description

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.

Further Study Information

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 to first-line platinum-based chemotherapy, with subsequent progression >/= 90 days after completing chemotherapy) or refractory (defined as no objective response to prior platinum-based therapy or progression < 90 days after completing prior platinum-based therapy);
  • 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, or 2.

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 or topotecan treatment.

Trial Contact Information

Trial Lead Organizations/Sponsors

Celgene Corporation

Markus Renschler, M.D.Study Director

Mary E Bartlett, BSN, RNPh: 913-266-0513
  Email: mbartlett@celgene.com

Trial Sites

U.S.A.
California
  Fresno
 Cancer Care Associates
 Nita Jensen Ph: 559-326-1222
  Email: jensenn@ccaonc.com
 Charles S Kuzma, M.D.Principal Investigator
  Los Angeles
 Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
 Ginny Naessig Ph: 310-423-0721
  Email: vnaessig@csocc.com
 Ronald Natale, MDPrincipal Investigator
Colorado
  Denver
 Rocky Mountain Cancer Centers - Denver Midtown
 Kelli Watkins Ph: 877-571-9172
  Email: kelli.watkins@usoncology.com
 Robert Jotte, M.D.Principal Investigator
Florida
  Ocala
 Ocala Oncology Center
 Kelli Watkins Ph: 877-571-9172
  Email: kelli.watkins@usoncology.com
 Craig Reynolds, M.D.Principal Investigator
  Ocoee
 Cancer Centers of Florida - Ocoee
 Kelli Watkins Ph: 877-571-9172
  Email: kelli.watkins@usoncology.com
 Carlos Alemany, M.D.Principal Investigator
  Orange Park
 Florida Oncology Associates
 Joan Ollie Ph: 904-272-3139
  Email: joan.ollie@foa.cc
 Jeffrey Bubis, M.D.Principal Investigator
Georgia
  Augusta
 Medical Oncology Associates, PC
 Laura Vaughn Ph: 706-722-4245
  Email: lvaughn@moaonline.net
 Donald C Townsend, Jr., M.D.Principal Investigator
Illinois
  Joliet
 Joliet Oncology-Hematology Associates, Limited - West
 Maureen Clennon Ph: 815-730-3098
  Email: maureenc@jolietoncology.com
 Sanjiv Modi, M.D.Principal Investigator
  Niles
 Cancer Care and Hematology Specialists of Chicagoland - Niles
 Kelli Watkins Ph: 877-571-9172
  Email: kelli.watkins@usoncology.com
 Leonard M. KleinPrincipal Investigator
  Quincy
 Blessing Hospital Cancer Center
 Kelly Sorrill Ph: 217-277-5800 Ext.7780
  Email: ksorrill@quincymedgroup.com
 Raymond P. Smith, M.D.Principal Investigator
Indiana
  Indianapolis
 Central Indiana Cancer Centers - South
 Kelli Watkins Ph: 877-571-9172
  Email: kelli.watkins@usoncology.com
 David Loesch, M.D.Principal Investigator
  Terre Haute
 Hope Center
 Jan Weoker Ph: 812-234-0098
  Email: jan@hopeccancercenter.com
 Ashis Chakrabarti, M.D.Principal Investigator
Kansas
  Overland Park
 Kansas City Cancer Centers - Southwest
 Kelli Watkins Ph: 877-571-9172
  Email: kelli.watkins@usoncology.com
 Marcus A. NeubauerPrincipal Investigator
  Wichita
 Cancer Center of Kansas
 Jo Young Ph: 316-262-4467
  Email: youngjm@cancercareofkansas.com
 Shaker Dakhil, M.D.Principal Investigator
Louisiana
  New Orleans
 Tulane Cancer Center at Tulane University Hospital and Clinic
 Winifred Johnson Ph: 504-988-6121
  Email: wjohnson@tulane.edu
 Marcelo Blaya, M.D.Principal Investigator
Maine
  Scarborough
 Maine Center for Cancer Medicine and Blood Disorders - Scarborough
 Betsy Chase Ph: 207-885-7634
  Email: chasee@mccm.org
 Matthew Dugan, MDPrincipal Investigator
Maryland
  Baltimore
 Sinai Hospital of Baltimore, Inc.
 Judy Bosley Ph: 410-601-4392
  Email: jbosley@lifebridgehealth.org
 Rodrigo Erlich, M.D.Principal Investigator
  Bethesda
 Center for Cancer and Blood Disorders at Suburban Hospital
 Natalie Bongiorno Ph: 301-571-2016
  Email: nbongiorno@ccbdmd.com
 Victor M. PriegoPrincipal Investigator
  Westminster
 Alliance Hematology Oncology, PA at Carroll County Cancer Center
 Kelli Watkins Ph: 877-571-9172
  Email: kelli.watkins@usoncology.com
 Yousuf Gaffar, M.D.Principal Investigator
Michigan
  Kalamazoo
 Kalamazoo Hematology and Oncology
 Doreen Scholly Ph: 269-341-9200 Ext.212
  Email: dscholly@jasnetworks.net
 Jeffrey Letzer, M.D.Principal Investigator
  Southgate
 Michigan Hematology & Oncology Institute
 Amy Robinson Ph: 734-283-7511
  Email: studymhoi@sbcglobal.net
 Mayur Patel, M.D.Principal Investigator
Minnesota
  Minneapolis
 University of Minnesota Medical Center, Cancer Center
 Melinda Baxter Ph: 612-625-6150
  Email: Baxte095@umn.edu
 Arkadiusz DudekPrincipal Investigator
Missouri
  St. Joseph
 Saint Joseph Oncology, Incorporated
 Mary Ann Grant Ph: 816-271-2154
  Email: mgrant@nwmohealth.com
 Vicram Gupta, M.D.Principal Investigator
Nevada
  Las Vegas
 Comprehensive Cancer Centers of Nevada - Central Valley
 Kelli Watkins Ph: 877-571-9172
  Email: kelli.watkins@usoncology.com
 Matthew Galsky, M.D.Principal Investigator
New York
  Latham
 New York Oncology Hematology, P.C.
 Kelli Watkins Ph: 877-571-9172
  Email: kelli.watkins@usoncology.com
 Charles Weissman, M.D.Principal Investigator
  Syracuse
 SUNY Upstate Medical University Hospital
 Linda Spillet Ph: 315-464-8237
  Email: spilletl@upstate.edu
 Chirag Shah, M.D.Principal Investigator
North Carolina
  Chapel Hill
 Lineberger Comprehensive Cancer Center
 Tammy Allred Ph: 919-966-4432
  Email: tammy_allred@med.unc.edu
 Mark Socinski, MDPrincipal Investigator
  Raleigh
 Cancer Centers of North Carolina
 Kelli Watkins Ph: 877-571-9172
  Email: kelli.watkins@usoncology.com
 William R. BerryPrincipal Investigator
  Winston-Salem
 Piedmont Hematology-Oncology Associates
 Don McCall Ph: 336-277-8887
  Email: dmccall@phoa.org
 Eugene Paschold, M.D.Principal Investigator
Ohio
  Canton
 Gabrail Cancer Center - Canton Office
 Carrie Smith Ph: 330-492-3345
  Email: csmith@gabrailcancercenter.com
 Nashat Yousif GabrailPrincipal Investigator
  Kettering
 Greater Dayton Cancer Center
 Kelli Watkins Ph: 877-571-9172
  Email: kelli.watkins@usoncology.com
 Robert N. RajuPrincipal Investigator
Oklahoma
  Oklahoma City
 Cancer Care Associates - West
 Heather Mossauer Ph: 405-945-9644
  Email: heather.mossauer@cancercareokla.com
 James E Reeves, Jr., M.D.Principal Investigator
  Tulsa
 Cancer Care Associates - Saint Francis Campus
 Sharon Franklin Ph: 918-499-2006
  Email: sharon.franklin@cancercareokla.com
 Pamela C Landon, M.D.Principal Investigator
Oregon
  Eugene
 Willamette Valley Cancer Center - Eugene
 Kelli Watkins Ph: 877-571-9172
  Email: kelli.watkins@usoncology.com
 John Caton, M.D.Principal Investigator
Pennsylvania
  Kingston
 Medical Oncology Associates of Wyoming Valley, PC
 Kelli Watkins Ph: 877-571-9172
  Email: kelli.watkins@usoncology.com
 Bruce Saidman, M.D.Principal Investigator
  Philadelphia
 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
 Maureen O'Connell Ph: 215-955-9244
  Email: maureen.oconnell@jefferson.edu
 Rita Axelrod, MDPrincipal Investigator
South Carolina
  Greenville
 Cancer Centers of the Carolinas - Eastside
 Kelli Watkins Ph: 877-571-9172
  Email: kelli.watkins@usoncology.com
 William Edenfield, M.D.Principal Investigator
Tennessee
  Nashville
 Sarah Cannon Cancer Center at Centennial Medical Center
 Raymond Hernandez Ph: 615-329-7489
  Email: raymond.hernandez@scresearch.net
 David R Spigel, MDPrincipal Investigator
Texas
  Amarillo
 Texas Oncology, PA - Amarillo
 Kelli Watkins Ph: 877-571-9172
  Email: kelli.watkins@usoncology.com
 Leonardo Forero, M.D.Principal Investigator
  Corpus Christi
 CHRISTUS Spohn Cancer Center
 Melanie Dees Ph: 361-887-0067
  Email: mdeesresearch@yahoo.com
 Yvonne Manalo, M.D.Principal Investigator
  Dallas
 Texas Oncology, PA at Charles A. Sammons Cancer Center
 Kelli Watkins Ph: 877-571-9172
  Email: kelli.watkins@usoncology.com
 Kartik Konduri, M.D.Principal Investigator
 Texas Oncology, PA at Texas Cancer Center Medical City Dallas
 Kelli Watkins Ph: 877-571-9172
  Email: kelli.watkins@usoncology.com
 Michael Savin, M.D.Principal Investigator
  Webster
 Deke Slayton Cancer Center
 Kelli Watkins Ph: 877-571-9172
  Email: kelli.watkins@usoncology.com
 Guru Sonpavde, M.D.Principal Investigator
  Wichita Falls
 Texoma Cancer Center
 Kelli Watkins Ph: 877-571-9172
  Email: kelli.watkins@usoncology.com
 Brian K Ulrich, M.D.Principal Investigator
Virginia
  Norfolk
 Virginia Oncology Associates - Lake Wright
 Kelli Watkins Ph: 877-571-9172
  Email: kelli.watkins@usoncology.com
 Paul R. ConklingPrincipal Investigator
Washington
  Vancouver
 Northwest Cancer Specialists at Vancouver Cancer Center
 Kelli Watkins Ph: 877-571-9172
  Email: kelli.watkins@usoncology.com
 David A. SmithPrincipal Investigator
Australia
  Woodville South
 Queen Elizabeth Hospital
 Louise Pirc
  Email: louise.pirc@nwahs.sa.gov.au
 Ken P Pittman, M.D.Principal Investigator
New South Wales
  Wollongong
 New South Wales Southern Medical Day Care Centre
 Sue Parker Ph: 61 2 4228 6200
  Email: bentpark@bigpond.com
 Philip Clingam, ProfessorPrincipal Investigator
Queensland
  Woolloongabba
 The Princess Alexandra Hospital, Dept of Respiratory Medicine
 Margaret Dauth Ph: +61 7 3240 2584
  Email: margaret_dauth@health.qld.gov.au
 Keith Horwood, MDPrincipal Investigator
South Australia
  Bedford Park
 Flinders Medical Centre
 Christos Karapetis, MD Ph: 08 8204 8997
  Email: chris.karapetis@fmc.sa.gov.au
 Christos Karapetis, MDPrincipal Investigator
Austria
  Linz
 Allgemeines Krankenhaus der Stadt Linz, Abteilung fur Atem und Lungenkrankheiten
 Wolfgang Pfeifer, M.D. Ph: 43 732 7806 6916
  Email: wolfgang.pfeifer@akh.linz.at
 Wolfgang Pfeifer, M.D.Principal Investigator
  Wels
 Klinikum Weis-Grieskirchen GmbH
 Rainer Kolb, M.D. Ph: 43 7242 415 2382
  Email: rainer.kolb@klinikum-wels.at
 Rainer Kolb, M.D.Principal Investigator
  Wien
 Allegemeines Krankenhaus Wien, Univ. Klinik fur Innere, Medizin I
 Robert Pirker Ph: +43 1404004422
  Email: robert.pirker@meduniwien.ac.at
 Robert Pirker, ProfPrincipal Investigator
 Krankenhaus Hietzing, 5 Med. Abteilung mit Onkologie
 Ernst Ulsperger, M.D. Ph: 43 180 110 2239
  Email: ernst.ulsperger@wienkav.at
 Ernst Ulsperger, M.D.Principal Investigator
Belgium
  Brussel
 Academisch Ziekenhuis der Vrije Universiteit Brussel
 Denis Schallier, M.D. Ph: 32 2 477 64 15
  Email: denis.schallier@uzbrussel.be
 Denis Schallier, M.D.Principal Investigator
  Edegem
 Universitair Ziekenhuis Antwerpen, Dept. Respiratory Diseases
 Paul Germonpre Ph: 32 3 821 3522
  Email: paul.germonpre@uza.be
 Paul Germonpre, ProfessorPrincipal Investigator
  Leuven
 U.Z. Gasthuisberg
 Professor Kristiaan Nackaerts Ph: 32 16 34 68 02
  Email: kristiaan.nackaerts@uz.kuleuven.ac.be
 Professor Kristiaan NackaertsPrincipal Investigator
  Liege
 C.H.U. Sart-Tilman
 Leon Bosquee, M.D. Ph: 32 4366 7401
  Email: lbosquee@chu.ulg.ac.be
 Leon Bosquee, M.D.Principal Investigator
Czech Republic
  Ostrava-Poruba
 Fakultni Nemocnice Ostrava
 Jaromir Roubec, MUDr Ph: +420 597 372 240
  Email: jaromir.roubec@fnspo.cz
 Jaromir Roubec, MUDrPrincipal Investigator
Denmark
  Copenhagen
 Rikshospitalet, Finsen Center
 Seppo W Langer, MD Ph: +45 35 45 8680
  Email: seppo.langer@rh.regionh.dk
 Seppo W Langer, MDPrincipal Investigator
  Herlev
 Copenhagen County Herlev University Hospital
 Bente Holm, M.D. Ph: 45 44 88 44 88
  Email: benhol01@heh.regionh.dk
 Bente Holm, M.D.Principal Investigator
  Odense C
 Odense University Hospital
 Karin H Hansen, M.D. Ph: 45 6541 1867
  Email: karin.holmskov@ouh.regionsddanmark.dk
 Karin H Hansen, M.D.Principal Investigator
Germany
  Bad Berka
 Zentralklinik Bad Berka
 Reiner Burkhard Bonnet, Prof Ph: +49 36 458 51 501
  Email: pne@zentralklinik-bad-berka.de
 Reiner Burkhard Bonnet, ProfPrincipal Investigator
  Berlin
 Charité Universitätsmedizin Berlin
 Susanne Beier Ph: +49 30 8445 4507
  Email: susanne.beier@charite.de
 Alexander Schmittel, MDPrincipal Investigator
  Essen
 Innere Universitaetsklinik und Poliklinik - Tumorforschung
 Wilfried Eberhardt, MD Ph: +49 201 723 3131
  Email: Wilfried.Eberhardt@uni-essen.de
 Wilfried Eberhardt, MDPrincipal Investigator
  Gauting
 Asklepios Fachkliniken Muenchen Gauting
 Joachim von Pawel, M.D. Ph: 49-89 8 57 91 2011
  Email: j.pawel@asklepios.com
 Joachim von Pawel, M.D.Principal Investigator
  Grosshansdorf
 Krankenhaus Grosshansdorf, Zentrum fur Pneumologie und Thoraxchirurgie
 Martin Reck, M.D. Ph: 49 4102 601 188
  Email: dr.martin.reck@web.de
 Martin Reck, M.D.Principal Investigator
  Halle (Saale)
 Staedtisches Krankenhaus Martha-Maria Halle-Doelau
 Wolfgang Schutte, M.D. Ph: 49 345 559 1440
  Email: schutte-wolfgang@web.de
 Wolfgang Schutte, M.D.Principal Investigator
  Heidelberg
 Thoraxklinik am Universitätsklinikum Heidelberg AG
 Martin Steins, MD Ph: +49 6221 396 8303
  Email: martin.steins@thoraxklinik-heidelberg.de
 Martin Steins, ProfPrincipal Investigator
  Karlsruhe
 St. Vincentius - Kliniken
 Professor Joerg Mezger Ph: 49 721 81 08 30 14
  Email: joerg.mezger@vincentius-ka.de
 Professor Joerg MezgerPrincipal Investigator
  Mainz
 Katholisches Klinikum Mainz, St. Hildegardis Krankenhaus
 Professor Dr. Cornelius Kortsik Ph: 49 6131 147 606
  Email: pneumo-shk@kkmainz.de
 Professor Dr. Cornelius KortsikPrincipal Investigator
  Mannheim
 Klinikum Mannheim GmbH, Chirugische Klinik, Thorakale Onkologie
 Christian Manegold Ph: 49 621 38 31 496
  Email: prof.manegold@t-online.de
 Professor Christian ManegoldPrincipal Investigator
Hungary
  Budapest
 Országos Korányi Tbc és Pulmonológiai Intézet
 Miklos Zsiray, MD Ph: + 36 1 391 3200
  Email: zsiray@koranyi.hu
 Miklos Zsiray, MDPrincipal Investigator
 Semmelweis University
 Pál Magyar, MD Ph: +36 1 355 8682 or 9733
  Email: magyar@pulm.sote.hu
 Pál Magyar, MDPrincipal Investigator
  Matrahaza
 Matrai Gyogyintezet
 Istvan Albert, M.D. Ph: 36 37 574 517
  Email: dr.albert@freemail.hu
 Istvan Albert, M.D.Principal Investigator
  Pecs
 County Hospital Baranya
 Zoltan Baliko, M.D., M.D. Ph: 36 72 533 133
  Email: baliko.z@gmail.com
 Zoltan Baliko, M.D.Principal Investigator
  Sopron
 Erzsébet Hospital Sopron
 Károly Fónay, MD Ph: +36 99 312 120
  Email: fonay@sopkorh.elender.hu
 Károly Fónay, MDPrincipal Investigator
Italy
  Modena
 Azienda Ospedaliera - Universitaria di Modena
 PierFranco Conte, Professor Ph: 39 059 422 4109
  Email: conte.pierfranco@unimore.it
 PierFranco Conte, ProfessorPrincipal Investigator
Poland
  Bystra
 Specjalistyczny Zespol Chorob Pluc i Gruzlicy w Bystrej
 Elzbieta Sobol-Grzesiak, MD Ph: +48 33 499 18 41
  Email: sobolgrzesiak@o2.pl
 Elzbieta Sobol-Grzesiak, MDPrincipal Investigator
  Gdansk
 Akademickie Centrum Kliniczne
 Jacek Jassem Ph: +48 58 349 22 70
  Email: jjassem@amg.gda.pl
 Jacek Jassem, ProfPrincipal Investigator
  Lublin
 Centrum Onkologii Ziemi Lubelskiez
 Elzbieta Staroslawska, MD Ph: +48 81 747 75 11 Ext.130
  Email: star@oncol.am.lublin.pl
 Elzbieta Staroslawska, MDPrincipal Investigator
  Wodzislaw Slaski
 Wojewódzki Szpital Chorób Pluc im Alojzego Pawelca w Wodzislawiu Slaskim
 Jacek Gabrys, MD Ph: +48 32 45 37 116
  Email: jacekgabrys@op.pl
 Jacek Gabrys, MDPrincipal Investigator
Spain
  Malaga
 Hospital Universitario Virgin de la Victoria
 Eva Saiz Ph: +34 65 423 7281
  Email: datamanagerhcuvv@yahoo.es
 Jose Manuel Trigo, MDPrincipal Investigator
United Kingdom
  Edinburgh
 Edinburgh Cancer Research Centre
 Melanie Jane Mackean, MD Ph: +44 131 537 3053
  Email: melanie.mackean@luht.scot.nhs.uk
 Melanie Jane Mackean, MDPrincipal Investigator
  Manchester
 Christie Hospital NHS Foundation Trust
 Paul Lorigan, M.D. Ph: 44 161 446 3126
  Email: Paul.Lorigan@christie.nhs.uk
 Paul Lorigan, M.D.Principal Investigator
  Surrey
 Royal Marsden - Surrey
 Mary O'Brien, M.D. Ph: +44 208 661 32 78
  Email: Mary.O'Brien@rmh.nhs.uk
 Mary O'Brien, MDPrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00547651
Information obtained from ClinicalTrials.gov on January 08, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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