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:
Celgene Corporation
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
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00547651
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| 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 Oncology, P.A. (Main) | |
| Dallas, Texas, United States, 75246 | |
| Texas Cancer Center at Medical City (Main) | |
| Dallas, Texas, United States, 75230-2510 | |
| 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 | |
| Krankenhaus Hietzing, 5 Med. Abteilung mit Onkologie | |
| Wien, Austria, 1130 | |
| Allegemeines Krankenhaus Wien, Univ. Klinik fur Innere, Medizin I | |
| Wien, Austria, 1090 | |
| 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 | |
| Semmelweis University of Medicine | |
| Budapest, Hungary, 1125 | |
| Országos Korányi Tbc és Pulmonológiai Intézet | |
| Budapest, Hungary, 1529 | |
| 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 Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Amrubicin Topotecan Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013