A Study of Mapatumumab in Combination With Paclitaxel and Carboplatin in Subjects With Non-small Cell Lung Cancer
NCT ID: NCT00583830
Last Updated: 2013-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
111 participants
INTERVENTIONAL
2007-01-31
2011-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Paclitaxel and carboplatin
Paclitaxel
200 mg/m\^2 IV (in the vein), on day 1 of each 21 day cycle
Carboplatin
AUC 6.0 mg min/ml IV (in the vein), on day 1 of each 21 day cycle
B
Paclitaxel, carboplatin and Mapatumumab 10 mg/kg
Mapatumumab
10 mg/kg IV (in the vein), on day 1 of each 21 day cycle
Paclitaxel
200 mg/m\^2 IV (in the vein), on day 1 of each 21 day cycle
Carboplatin
AUC 6.0 mg min/ml IV (in the vein), on day 1 of each 21 day cycle
C
Paclitaxel, carboplatin and Mapatumumab 30 mg/kg
Mapatumumab
30 mg/kg IV (in the vein), on day 1 of each 21 day cycle
Paclitaxel
200 mg/m\^2 IV (in the vein), on day 1 of each 21 day cycle
Carboplatin
AUC 6.0 mg min/ml IV (in the vein), on day 1 of each 21 day cycle
Interventions
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Mapatumumab
30 mg/kg IV (in the vein), on day 1 of each 21 day cycle
Mapatumumab
10 mg/kg IV (in the vein), on day 1 of each 21 day cycle
Paclitaxel
200 mg/m\^2 IV (in the vein), on day 1 of each 21 day cycle
Carboplatin
AUC 6.0 mg min/ml IV (in the vein), on day 1 of each 21 day cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18 years or older
Exclusion Criteria
* Received radiation therapy within 4 weeks before randomization
* Major surgery within 4 weeks before randomization
* Minor surgery within 2 weeks before randomizaiton
* Systemic steroids within 1 week before randomization
* Any grade 2 or greater neuropathy
* History of severe (Grade 4) hypersensitivity reaction to products containing Cremophor EL (cyclosporine, teniposide)
* History of any infection requiring hospitalization or antibiotics within 2 weeks before randomization
* Known brain or spinal cord metastases
* History of other cancers within 5 years before randomization
* Known HIV, hepatitis-B or hepatitis-C infection
* Pregnant or breast-feeding women
* Previously treated with Mapatumumab
18 Years
ALL
No
Sponsors
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Human Genome Sciences Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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Birmingham Hematology and Oncology Associates, LLC
Birmingham, Alabama, United States
Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage, California, United States
University of Colorado Health Sciences Center
Aurora, Colorado, United States
Osceola Cancer Center
Kissimmee, Florida, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
LaGrange Oncology Associates
LaGrange, Illinois, United States
Orchard Research, LLC
Skokie, Illinois, United States
Kentuckiana Cancer Institute, PLLC
Louisville, Kentucky, United States
University of Maryland, Greenebaum Cancer Center
Baltimore, Maryland, United States
Chevy Chase Health Care
Chevy Chase, Maryland, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Medical University of South Carolina: Hollings Cancer Center
Charleston, South Carolina, United States
The Sarah Cannon Cancer Center
Nashville, Tennessee, United States
UT Health Science Center at San Antonio, Be Well Center
San Antonio, Texas, United States
Fairfax-Northern Virginia Hematology Oncology, PC
Fairfax, Virginia, United States
Charite - Campus Mitte, Universitätsmedizin Berlin, Abteilung Onkologie und Hämatologie
Berlin, , Germany
Universitätsmedizin Berlin, Centrum für Innere Medizin
Berlin, , Germany
Asklepios Fachkliniken München-Gauting
Gauting, , Germany
Krankenhaus Großhansdorf
Großhansdorf, , Germany
Krankenhaus Martha-Maria Halle-Dölau
Halle, , Germany
Universitätsklinik Magdeburg, Klinik für Kardiologie, Angiologie und Pneumologie
Magdeburg, , Germany
Klinikum der Johannes-Gutenberg-Universität Mainz
Mainz, , Germany
Universitätsklinikum Mannheim, Chirurgische Klinik
Mannheim, , Germany
Pius-Hospital
Oldenburg, , Germany
Paracelsus Klinik, Zentrum für Tumordiagnostik und -therapie
Osnabrück, , Germany
Fővárosi Önkormányzat Uzsoki Utcai Kórház
Budapest, , Hungary
Országos Korányi TBC és Pulmonológiai Intezet
Budapest, , Hungary
Debrecen University, Medical and Health Center, Dept of Oncology
Debrecen, , Hungary
Kenézy Gyula Kórház, Debrecen, Pulmonológia
Debrecen, , Hungary
Institutul Oncologic 'Prof Dr. Al Trestioreanu' Bucuresti
Bucharest, , Romania
Institutul Oncologic 'Prof . Dr. I. Chiricuta' Cluj-Napoca
Cluj-Napoca, , Romania
Spitalul Clinic Judetean Oradea, Oncology Department
Oradea, , Romania
Countries
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References
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von Pawel J, Harvey JH, Spigel DR, Dediu M, Reck M, Cebotaru CL, Humphreys RC, Gribbin MJ, Fox NL, Camidge DR. Phase II trial of mapatumumab, a fully human agonist monoclonal antibody to tumor necrosis factor-related apoptosis-inducing ligand receptor 1 (TRAIL-R1), in combination with paclitaxel and carboplatin in patients with advanced non-small-cell lung cancer. Clin Lung Cancer. 2014 May;15(3):188-196.e2. doi: 10.1016/j.cllc.2013.12.005. Epub 2013 Dec 27.
Other Identifiers
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HGS1012-C1072
Identifier Type: -
Identifier Source: org_study_id