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

Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00547651
• Other study ID #: AMR PH GL 2007 CL001
• Status: Completed
• Phase: Phase 3
• Start date: September 1, 2007
• Est. completion date: May 1, 2011

Study information

• Verified date: October 2019
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 637
• Est. completion date: May 1, 2011
• Est. primary completion date: May 1, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

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
• 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

Locations

Country	Name	City	State
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	Royal North Shore Hospital	St. Leonards	New South Wales
Australia	New South Wales Southern Medical Day Care Centre	Wollongong	New South Wales
Australia	The Queen Elizabeth Hospital	Woodville South
Australia	The Princess Alexandra Hospital, Dept of Respiratory Medicine	Woolloongabba	Queensland
Austria	Allgemeines Krankenhaus der Stadt Linz, Abteilung fur Atem und Lungenkrankheiten	Linz
Austria	Klinikum Weis-Grieskirchen GmbH	Wels
Austria	Allegemeines Krankenhaus Wien, Univ. Klinik fur Innere, Medizin I	Wien
Austria	Krankenhaus Hietzing, 5 Med. Abteilung mit Onkologie	Wien
Belgium	UZ Brussel, Medical Oncology and Hematology	Brussel
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	Liege
Bulgaria	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
Canada	London Regional Cancer Centre	London	Ontario
Canada	Royal Victoria Hospital	Montreal	Quebec
Canada	Fraser Valley Cancer Centre-Surrey Memorial Hospital	Surrey	British Columbia
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	Humber River Regional Hospital	Weston	Ontario
Czechia	Fakultni Nemocnice Ostrava	Ostrava-Poruba
Czechia	Fakultní Thomayerova nemocnice s poliklinikou	Praha
Czechia	Faculty Hospital Motol	Praha 5
Czechia	Masarykova nemocnice v Ústí nad Labem	Ústí nad Labem
Denmark	Rikshospitalet, Finsen Center	Copenhagen
Denmark	Herlev Hospital, Onkologisk afdeling R	Herlev
Denmark	Odense Universitetshospital,Onkologisk afdeling R	Odense C
France	Centre François Baclesse	Caen Cedex 5
France	Hôpital de la Croix-Rousse	Lyon Cedex 04
France	CHU Montpellier - Unité de Cancérologie Thoracique	Montpellier Cedex
France	Institut Gustave Roussy	Villejuif
Germany	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 (Saale)
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
Hungary	Országos Korányi Tbc és Pulmonológiai Intézet	Budapest
Hungary	Semmelweis University of Medicine	Budapest
Hungary	DEODEC	Debrecen
Hungary	Matrai Gyogyintezet	Matrahaza
Hungary	County Hospital Baranya	Pecs
Hungary	Erzsébet Hospital Sopron	Sopron
Italy	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
Netherlands	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
Poland	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	Kraków
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	Wodzislaw Slaski
Spain	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	Malaga
Spain	Hospital General Universitario de Valencia	Valencia
Switzerland	Kantonsspital Aarau	Aarau
Switzerland	Kantonsspital Graubünden	Chur
Switzerland	Universitätsspital Zürich	Zurich
United Kingdom	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 States	Texas Oncology, P.A.	Amarillo	Texas
United States	Medical Oncology Associates of Augusta	Augusta	Georgia
United States	University of Colorado Health Science Centre	Aurora	Colorado
United States	Sinai Hospital of Baltimore, Inc.	Baltimore	Maryland
United States	Center for Cancer and Blood Disorders	Bethesda	Maryland
United States	Gabrail Cancer Center	Canton	Ohio
United States	Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina
United States	Missouri Cancer Associates	Columbia	Missouri
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	Rocky Mountain Cancer Center - Midtown (Main)	Denver	Colorado
United States	Regional Cancer Care	Durham	North Carolina
United States	Willamette Valley Cancer Center (Main)	Eugene	Oregon
United States	Fairfax Northern Virginia Hematology/Oncology	Fairfax	Virginia
United States	Cancer Care Associates of Fresno Medical Group, Inc.	Fresno	California
United States	Cancer Centers of the Carolinas (Main)	Greenville	South Carolina
United States	Central Indiana Cancer Centers	Indianapolis	Indiana
United States	Joliet Oncology-Hematology Associates, Ltd.	Joliet	Illinois
United States	Kalamazoo Hematology and Oncology	Kalamazoo	Michigan
United States	Greater Dayton Cancer Center (Main)	Kettering	Ohio
United States	Medical Oncology Associates	Kingston	Pennsylvania
United States	Comprehensive Care Centers of Nevada (Main)	Las Vegas	Nevada
United States	New York Oncology Hematology, P.C.	Latham	New York
United States	Little Rock Hematology Oncology Associates	Little Rock	Arkansas
United States	Cedars-Sinai Outpatient Cancer Center	Los Angeles	California
United States	Marshfield Clinic	Marshfield	Wisconsin
United States	Jayne Gurtler MD, Laura Brizn MD, Angelo Russo MD, and Janet Burroff MD, APMC	Metairie	Louisiana
United States	Advanced Medical Specialties	Miami	Florida
United States	University of Minnesota Medical Center, Cancer Center	Minneapolis	Minnesota
United States	Northwest Alabama Cancer Center	Muscle Shoals	Alabama
United States	The Sarah Cannon Research Institute/TN Oncology	Nashville	Tennessee
United States	Tulane University Health Sciences Center	New Orleans	Louisiana
United States	Cancer & Hematology Specialists of Chicago (Main)	Niles	Illinois
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	Ocala Oncology Center	Ocala	Florida
United States	Cancer Centers of Florida, P.A.	Ocoee	Florida
United States	West Texas Cancer Center-Texas Oncology	Odessa	Texas
United States	Cancer Care Associates	Oklahoma City	Oklahoma
United States	Florida Oncology Associates	Orange Park	Florida
United States	Kansas City Cancer Center (Main)	Overland Park	Kansas
United States	Sacred Heart Medical Oncology	Pensacola	Florida
United States	Illinois Cancer Care	Peoria	Illinois
United States	Thomas Jefferson Memorial Hospital	Philadelphia	Pennsylvania
United States	UPMC Cancer Pavilion	Pittsburgh	Pennsylvania
United States	Cancer Care at Blessing Hospital	Quincy	Illinois
United States	Cancer Centers of North Carolina (Main)	Raleigh	North Carolina
United States	Blue Ridge Cancer Care	Roanoke	Virginia
United States	St. Joseph Oncology, Inc.	Saint Joseph	Missouri
United States	Maine Center for Cancer Medicine and Blood Disorders	Scarborough	Maine
United States	Michigan Hematology & Oncology Institute	Southgate	Michigan
United States	SUNY Upstate Medical University - Regional Oncology Center	Syracuse	New York
United States	Hope Center	Terre Haute	Indiana
United States	Arizona Oncology Associates	Tucson	Arizona
United States	Cancer Care Associates	Tulsa	Oklahoma
United States	Northwest Cancer Specialists - Vancouver (Main)	Vancouver	Washington
United States	Texas Oncology, P.A.	Webster	Texas
United States	Alliance Hematology Oncology, P.A. (Main)	Westminster	Maryland
United States	Cancer Center of Kansas	Wichita	Kansas
United States	Texoma Cancer Center	Wichita Falls	Texas
United States	Piedmont Hematology Oncology Associates	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  Czechia,  Denmark,  France,  Germany,  Hungary,  Italy,  Netherlands,  Poland,  Spain,  Switzerland,  United Kingdom, 

References & Publications (1)

von Pawel J, Jotte R, Spigel DR, O'Brien ME, Socinski MA, Mezger J, Steins M, Bosquée L, Bubis J, Nackaerts K, Trigo JM, Clingan P, Schütte 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Until death from any cause
Secondary	To further characterize the clinical benefit of amrubicin compared with topotecan in terms of objective response rate		Until death
Secondary	To further characterize the clinical benefit of amrubicin compared with topotecan in terms of progression-free survival.		Until death
Secondary	To further characterize the clinical benefit of amrubicin compared with topotecan in terms of duration of response		Until death
Secondary	To further characterize the clinical benefit of amrubicin compared with topotecan in terms of time to tumor progression		Until death
Secondary	To further characterize the clinical benefit of amrubicin compared with topotecan in terms of safety		Until death
Secondary	To further characterize the clinical benefit of amrubicin compared with topotecan in terms of quality of life		Until death