Spots Global Cancer Trial Database for Safety and Efficacy Study of Abraxane as Maintenance Treatment After Abraxane Plus Carboplatin in 1st Line Stage IIIB / IV Squamous Cell Non-small Cell Lung Cancer
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Trial Identification
Brief Title: Safety and Efficacy Study of Abraxane as Maintenance Treatment After Abraxane Plus Carboplatin in 1st Line Stage IIIB / IV Squamous Cell Non-small Cell Lung Cancer
Official Title: A Phase III, Randomized, Open-Label, Multi-Center, Safety and Efficacy Study to Evaluate Nab-Paclitaxel (Abraxane®) as Maintenance Treatment After Induction With Nab-Paclitaxel Plus Carboplatin in Subjects With Squamous Cell Non-Small Cell Lung Cancer (NSCLC)
Study ID: NCT02027428
Study Description
Brief Summary: Maintenance treatment of advanced stage squamous cell NSCLC. Phase III, randomized, open-label, multi-center study of nab-paclitaxel with best supportive care (BSC) or BSC alone as maintenance treatment after response or stable disease (SD) with nab-paclitaxel plus carboplatin as induction in subjects with stage IIIB/IV squamous cell NSCLC. Subjects who discontinued treatment from the maintenance part for any reason other than withdrawal of consent, lost to follow-up, or death, were entered into a Follow-up period that had a visit 28 days after progression or discontinuation. Those who entered Follow-up without progression continued with follow-up scans according to standard of care (SOC) until documentation of progression of disease. Additionally, subjects were followed for OS by phone approximately every 90 days for a minimum of 18 months, for up to approximately 5 years after the last subject was randomized.
Detailed Description: The sponsor used 15 Sep 2017 as the database cut-off date.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Clearview Cancer Institute Oncology Specialties, P.C, Huntsville, Alabama, United States
Palo Verde Hematology Oncology, Ltd., Glendale, Arizona, United States
Arizona Clinical Research Center, Tucson, Arizona, United States
Genesis Cancer Center, Hot Springs, Arkansas, United States
City of Hope Cancer Center, Duarte, California, United States
Cancer Care Associates of Fresno Medical Group Inc, Fresno, California, United States
University of California San Diego Moores Cancer Center, La Jolla, California, United States
Clinical Trials and Research Associates, Montebello, California, United States
VA Palo Alto Health Care System, Palo Alto, California, United States
Rocky Mountain Cancer Centers, LLP, Denver, Colorado, United States
Yale Cancer Center, New Haven, Connecticut, United States
Lynn Cancer Institute, Boca Raton, Florida, United States
Florida Cancer Specialists, Fort Myers, Florida, United States
Watson Clinic, LLP Center for Cancer Care and Research, Lakeland, Florida, United States
University of Miami Miller School of Medicine Jackson Memorial Hospital, Miami, Florida, United States
Ocala Oncology Center, Ocala, Florida, United States
Orlando Health, Inc, Orlando, Florida, United States
Memorial Cancer Institute West, Pembroke Pines, Florida, United States
Florida Cancer Specialists, Saint Petersburg, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
University Cancer and Blood Center, LLC, Athens, Georgia, United States
University of Chicago, Chicago, Illinois, United States
Joliet Oncology-Hematology Associates, Ltd., Joliet, Illinois, United States
Illinois Cancer Specialists, Niles, Illinois, United States
Indiana University Medical Center, Indianapolis, Indiana, United States
Investigative Clinical Research of Indiana, LLC, Indianapolis, Indiana, United States
Kansas University Medical Center, Westwood, Kansas, United States
Cancer Center of Kansas (MAT), Wichita, Kansas, United States
Kentucky Cancer Clinic, Hazard, Kentucky, United States
Norton Healthcare, Louisville, Kentucky, United States
University of Louisville, J.G. Brown Cancer Center, Louisville, Kentucky, United States
Norton Cancer Institute Louisville Oncology, Louisville, Kentucky, United States
LSU Health Sciences Center, New Orleans, Louisiana, United States
Maine Research Associates, Auburn, Maine, United States
Eastern Maine Medical Center, Brewer, Maine, United States
Center For Cancer and Blood Disorders, Bethesda, Maryland, United States
Meritus Medical Center, Hagerstown, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Detroit Clinical Research Center, Farmington Hills, Michigan, United States
Western Michigan Cancer Center, Kalamazoo, Michigan, United States
St Joseph Oncology, Saint Joseph, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Mercy Medical Research Institute, Springfield, Missouri, United States
Englewood Hospital and Medical Center, Englewood, New Jersey, United States
Hematology-Oncology Associates of NNJ, P, Morristown, New Jersey, United States
New York Oncology Hematology P.C., Albany, New York, United States
Montefiore Medical Center, Bronx, New York, United States
Montefiore Medical Center Albert Einstein Cancer Center, Bronx, New York, United States
Clinical Research Alliance, Lake Success, New York, United States
NYU Langone Medical Center, Lake Success, New York, United States
Beth Israel Medical Centers, New York, New York, United States
NYU Langone Medical Center, New York, New York, United States
Icahn School of Medicine at Mount Sinai Medical Center, New York, New York, United States
Rochester General Hospital, Rochester, New York, United States
SUNY Upstate Medical University, Syracuse, New York, United States
Carolinas Medical Center, Charlotte, North Carolina, United States
Southeastern Medical Oncology Center, Goldsboro, North Carolina, United States
Moses H. Cone Regional Cancer Center, Greensboro, North Carolina, United States
Hematology and Oncology Associates, Inc., Canton, Ohio, United States
Oncology Hematology Care, Inc., Cincinnati, Ohio, United States
University Hospitals Case Medical Center, Cleveland, Ohio, United States
The Mark H. Zangmeister Center, Columbus, Ohio, United States
Tri-County Hematology and Oncology Associates, Massillon, Ohio, United States
Toledo Community Oncology Program, Toledo, Ohio, United States
Mercy Clinic Oklahoma Communities, Inc., Oklahoma City, Oklahoma, United States
University of Oklahoma Peggy and Charles Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Erie Regional Cancer Center, Erie, Pennsylvania, United States
Abramson Cancer Center, Philadelphia, Pennsylvania, United States
University of Pennsylvania Health Systems, Philadelphia, Pennsylvania, United States
Allegheny Singer Research Institute, Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center - Cancer Pavilion, Pittsburgh, Pennsylvania, United States
Greenville Hospital System, Greenville, South Carolina, United States
Chattanooga Oncology Hematology Care, Chattanooga, Tennessee, United States
Associates in Oncology and Hematology, Chattanooga, Tennessee, United States
Thompson Cancer Survival Center, Knoxville, Tennessee, United States
Sarah Cannon Cancer Center, Nashville, Tennessee, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
TX Onc, PA- Beaumont, Beaumont, Texas, United States
Brooke Army Medical Center Francis Street Medical Center, Fort Sam Houston, Texas, United States
Center for Cancer and Blood Disorders, Fort Worth, Texas, United States
Houston Methodist Cancer Center, Houston, Texas, United States
UT Health Oncology, Houston, Texas, United States
Millenium Oncology, Houston, Texas, United States
TX Onc Tyler Cancer Center, Tyler, Texas, United States
Columbia Basin Hematology and Oncology, Kennewick, Washington, United States
Swedish Cancer Institute, Seattle, Washington, United States
St Mary's Medical Center, Huntington, West Virginia, United States
West Virginia University, Berkeley Medical Center, Cancer and Infusion Center, Martinsburg, West Virginia, United States
West Virginia University, Berkeley Medical Center, Cancer and Infusion Center, Morgantown, West Virginia, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
St. Antonius Hospital, Eschweiler, , Germany
Asklepios Fachkliniken Muenchen Gauting, Gauting, , Germany
Diakoniekrankenhaus Halle, Halle (Saale), , Germany
Universitatsklinikum Halle Saale, Halle, , Germany
Thorax Klinik, Heidelberg, , Germany
Universitat Des Saarlandes, Homburg, , Germany
Kliniken der Stadt Koln gGmbH - Krankenhaus Merheim, Koln, , Germany
Klinik Loewenstein gGmbH, Loewenstein, , Germany
Lungenklinik Lostau gGmbH, Lostau, , Germany
Universitatsklinikum Ulm, Ulm, , Germany
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati, Avellino, , Italy
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi, Bologna, , Italy
Azienda Ospedaliera Istituti Ospitalieri di Cremona, Cremona, , Italy
Istituto Nazionale Per La Ricerca Sul Cancro, Genova, , Italy
Istituto Europeo di Oncologia, Milano, , Italy
Azienda Ospedaliera San Gerardo, Monza, , Italy
Istituto Nazionale Tumori Regina Elena di Roma, Roma, , Italy
Ospedale San Vincenzo Taormina, Taormina, , Italy
Intituto Catalán de Oncología de Girona, Girona, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Madrid, , Spain
Hospital Universitario Central de Asturias, Oviedo, , Spain
Hospital General Universitario de Valencia, Valencia, , Spain
Hospital Universitari i Politecnic La Fe de Valencia, Valencia, , Spain
Hospital Universitario Lozano Blesa, Zaragoza, , Spain
Churchhill Hospital, Oxford, , United Kingdom
Royal Marsden Hospital, Sutton, , United Kingdom
Contact Details
Name: Teng Jin Ong, MD
Affiliation: Celgene
Role: STUDY_DIRECTOR
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