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

Sponsor

Celgene (Industry)

Overall Status

Completed

CT.gov ID

NCT00547651

Collaborator

(none)

637

Enrollment

140

Locations

Arms

Actual Duration (Months)

4.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Small Cell Lung Cancer	Drug: Amrubicin Drug: Topotecan	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

637 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Actual Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Topotecan hydrochloride Hycamtin

Arm

Intervention/Treatment

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 Names:

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 Names:

Topotecan hydrochloride

Hycamtin

Outcome Measures

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. [Until death from any cause]

Secondary Outcome Measures

To further characterize the clinical benefit of amrubicin compared with topotecan in terms of objective response rate [Until death]
To further characterize the clinical benefit of amrubicin compared with topotecan in terms of progression-free survival. [Until death]
To further characterize the clinical benefit of amrubicin compared with topotecan in terms of duration of response [Until death]
To further characterize the clinical benefit of amrubicin compared with topotecan in terms of time to tumor progression [Until death]
To further characterize the clinical benefit of amrubicin compared with topotecan in terms of safety [Until death]
To further characterize the clinical benefit of amrubicin compared with topotecan in terms of quality of life [Until death]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

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