Clinical trial NCT00583830: A Study of Mapatumumab in Combination With Paclitaxel and Carboplatin in Subjects With Non-small Cell Lung Cancer
Official title: A Phase 2, Randomized, Multi-Center, Open-Label Study to Evaluate the Efficacy and Safety of Mapatumumab in Combination With Carboplatin and Paclitaxel as First Line Therapy in Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Keywords: Lung Cancer
Lead sponsor: Human Genome Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2007-12-31
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy (disease response) and safety of mapatumumab in combination with carboplatin and paclitaxel as first line therapy in subjects with advanced non-small cell lung cancer (NSCLC).


Eligibility criteria: Inclusion Criteria:

* Patients with histologically or cytologically confirmed stage IIIB or stage IV advanced primary non-small cell lung cancinoma
* Age 18 years or older

Exclusion Criteria:

* Received investigational (not yet approved by a regulatory authority) or non-investigational agent to treat Lung Cancer
* 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

Primary outcomes:
measure: Objective response and Progression free survival
timeFrame: 6 cycles, or until disease progression or unacceptable toxicity develops
Secondary outcomes:
measure: Disease control; Overall survival; Response duration and time to response in responders; Frequency and severity of treatment-emergent adverse events; Laboratory parameters; and Serum mapatumumab concentrations for use in a PK analysis.
timeFrame: 6 cycles, or until disease progression or unacceptable toxicity develops
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Hematology and Oncology Associates, LLC
state: Alabama
city: Rancho Mirage
country: United States
facility: Desert Hematology Oncology Medical Group, Inc.
state: California
city: Aurora
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Kissimmee
country: United States
facility: Osceola Cancer Center
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Cancer Institute
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: LaGrange
country: United States
facility: LaGrange Oncology Associates
state: Illinois
city: Skokie
country: United States
facility: Orchard Research, LLC
state: Illinois
city: Louisville
country: United States
facility: Kentuckiana Cancer Institute, PLLC
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland, Greenebaum Cancer Center
state: Maryland
city: Chevy Chase
country: United States
facility: Chevy Chase Health Care
state: Maryland
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Charleston
country: United States
facility: Medical University of South Carolina: Hollings Cancer Center
state: South Carolina
city: Nashville
country: United States
facility: The Sarah Cannon Cancer Center
state: Tennessee
city: San Antonio
country: United States
facility: UT Health Science Center at San Antonio, Be Well Center
state: Texas
city: Fairfax
country: United States
facility: Fairfax-Northern Virginia Hematology Oncology, PC
state: Virginia
city: Berlin
country: Germany
facility: Charite - Campus Mitte, Universitätsmedizin Berlin, Abteilung Onkologie und Hämatologie
city: Berlin
country: Germany
facility: Universitätsmedizin Berlin, Centrum für Innere Medizin
city: Gauting
country: Germany
facility: Asklepios Fachkliniken München-Gauting
city: Großhansdorf
country: Germany
facility: Krankenhaus Großhansdorf
city: Halle
country: Germany
facility: Krankenhaus Martha-Maria Halle-Dölau
city: Magdeburg
country: Germany
facility: Universitätsklinik Magdeburg, Klinik für Kardiologie, Angiologie und Pneumologie
city: Mainz
country: Germany
facility: Klinikum der Johannes-Gutenberg-Universität Mainz
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim, Chirurgische Klinik
city: Oldenburg
country: Germany
facility: Pius-Hospital
city: Osnabrück
country: Germany
facility: Paracelsus Klinik, Zentrum für Tumordiagnostik und -therapie
city: Budapest
country: Hungary
facility: Fővárosi Önkormányzat Uzsoki Utcai Kórház
city: Budapest
country: Hungary
facility: Országos Korányi TBC és Pulmonológiai Intezet
city: Debrecen
country: Hungary
facility: Debrecen University, Medical and Health Center, Dept of Oncology
city: Debrecen
country: Hungary
facility: Kenézy Gyula Kórház, Debrecen, Pulmonológia
city: Bucuresti
country: Romania
facility: Institutul Oncologic 'Prof Dr. Al Trestioreanu' Bucuresti
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic 'Prof . Dr. I. Chiricuta' Cluj-Napoca
city: Oradea
country: Romania
facility: Spitalul Clinic Judetean Oradea, Oncology Department
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.