Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT00050960
- Lead Sponsor
- Eisai Inc.
- Brief Summary
This study evaluates the use of Targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have not yet received chemotherapy for their lung cancer.
- Detailed Description
This study evaluates the use of Targretin capsules (bexarotene) in combination with Carboplatin and Paclitaxel for the treatment of metastatic non-small cell lung cancer in patients who have not yet received chemotherapy for their lung cancer. Every patient receives a platinum-containing chemotherapy every three weeks for at least four chemotherapy cycles (approximately four months). Half of the patients are randomly assigned to receive Targretin capsules once daily in addition to the chemotherapy. The other half is randomized to receive a standard platinum-containing chemotherapy without Targretin capsules.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 612
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description bexarotene with carboplatin and paclitaxel bexarotene with carboplatin and paclitaxel - carboplatin and paclitaxel carboplatin and paclitaxel -
- Primary Outcome Measures
Name Time Method Overall Survival From date of randomization to date of death
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (151)
Pacific Coast Hematology/Oncology Medical Group, Inc.
🇺🇸Fountain Valley, California, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Cancer Institute of Long Island, Inc.
🇺🇸Great Neck, New York, United States
South Shore Hematology Oncology Associates, PC
🇺🇸Rockville Centre, New York, United States
Cancer Specialists of South Texas, PA
🇺🇸Corpus Christi, Texas, United States
Central Indiana Cancer Centers
🇺🇸Indianapolis, Indiana, United States
Sharp Health Care
🇺🇸San Diego, California, United States
University of Florida/Jacksonville
🇺🇸Jacksonville, Florida, United States
Cancer and Blood Specialists of Nevada
🇺🇸Henderson, Nevada, United States
Cancer Centers of the Carolinas
🇺🇸Seneca, South Carolina, United States
Liberty Hematology/Oncology
🇺🇸Columbia, South Carolina, United States
Centre Hospitalier General de la Region Annecienne
🇫🇷Annecy Cedex, France
Algoma Regional Cancer Program - Sault Area Hospital
🇨🇦Sault Ste. Marie, Ontario, Canada
CHRU Hopital de Bois Guillaume
🇫🇷Bois Guillaume, France
Hopital du Cluzeau
🇫🇷Limoges Cedex, France
St. Lukes Hospital
🇺🇸Duluth, Minnesota, United States
Minnesota Oncology Hematology, P.A.
🇺🇸Minneapolis, Minnesota, United States
Kansas City Oncology and Hematology Group, Kansas City Cancer Centers
🇺🇸Overland Park, Kansas, United States
Bay Area Cancer Research Group, LLC
🇺🇸Concord, California, United States
Sutter Gould Medical Foundation
🇺🇸Modesto, California, United States
Southern California Kaiser Permanente Medical Group
🇺🇸San Diego, California, United States
Hematology Oncology Assoc. of Illinois
🇺🇸Skokie, Illinois, United States
New York Presbyterian Hospital, Weill Medical College of Cornell University
🇺🇸New York, New York, United States
Columbia Presbyterian Medical Center
🇺🇸New York, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
VA Medical Center
🇺🇸Northport, New York, United States
Nashat Y. Gabrail, MD, Inc.
🇺🇸Canton, Ohio, United States
Medical Oncology Associates of Wyoming Valley, PC
🇺🇸Kingston, Pennsylvania, United States
Hope Oncology
🇺🇸Richardson, Texas, United States
Arlington Fairfax Hematology Oncology
🇺🇸Arlington, Virginia, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Danville Hematology & Oncology, Inc.
🇺🇸Danville, Virginia, United States
Metropolitan Hematology/Oncology Medical Group
🇺🇸Los Angeles, California, United States
Arizona Clinical Research Center, Inc.
🇺🇸Tucson, Arizona, United States
Compassionate Cancer Care Medical Group, Inc.
🇺🇸Fountain Valley, California, United States
Thompson Cancer Survival Center
🇺🇸Knoxville, Tennessee, United States
Montgomery Cancer Center, L.L.C.
🇺🇸Montgomery, Alabama, United States
Texoma Cancer Center
🇺🇸Wichita Falls, Texas, United States
Boston Baskin Cancer Group
🇺🇸Memphis, Tennessee, United States
Hematology & Oncology Associates of South Texas
🇺🇸San Antonio, Texas, United States
Tyler Cancer Center
🇺🇸Tyler, Texas, United States
Yakima Regional Cancer Care Center, Internal Medicine Associates of Yakima, Inc.
🇺🇸Yakima, Washington, United States
Texas Cancer Center at Medical City
🇺🇸Dallas, Texas, United States
University of Texas, MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Dayton Oncology/Hematology Consultants
🇺🇸Dayton, Ohio, United States
Allison Cancer Center
🇺🇸Midland, Texas, United States
Columbus Community Clinical Oncology Program
🇺🇸Columbus, Ohio, United States
Oncology Hematology of Lehigh Valley, PC
🇺🇸Bethlehem, Pennsylvania, United States
Cancer Care Associates
🇺🇸Tulsa, Oklahoma, United States
UCSF/Mount Zion Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Rocky Mountain Cancer Centers - Midtown
🇺🇸Denver, Colorado, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Cancer Care Associates - Mercy Campus
🇺🇸Oklahoma City, Oklahoma, United States
Oncology/Hematology, Kaiser Permanente Northwest
🇺🇸Portland, Oregon, United States
Utah Cancer Specialists
🇺🇸Salt Lake City, Utah, United States
California Cancer Care, Inc.
🇺🇸Greenbrae, California, United States
Sant P. Chawla, Inc.
🇺🇸Los Angeles, California, United States
Coast Hematology and Oncology Associates
🇺🇸Long Beach, California, United States
Medical Oncology Care Associates
🇺🇸Orange, California, United States
Medical Group of North County, Inc., San Diego Cancer Center
🇺🇸Vista, California, United States
Comprehensive Cancer Care Specialists of Boca Raton
🇺🇸Boca Raton, Florida, United States
Washington Cancer Institute
🇺🇸Washington, District of Columbia, United States
Eastern Connecticut Hematology & Oncology
🇺🇸Norwich, Connecticut, United States
Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Oncology and Radiation Associates
🇺🇸Miami, Florida, United States
South Florida Oncology & Hematology Consultants
🇺🇸Plantation, Florida, United States
Florida Oncology Associates
🇺🇸Orange Park, Florida, United States
Watson Clinic
🇺🇸Lakeland, Florida, United States
Florida Cancer Institute
🇺🇸New Port Richey, Florida, United States
Medical Oncology Associates of Augusta
🇺🇸Augusta, Georgia, United States
Northwest Oncology and Hematology, SC
🇺🇸Elk Grove Village, Illinois, United States
St. Luke's/Mountain State Tumor Institute (MSTI)
🇺🇸Boise, Idaho, United States
Georgia Oncology Partners Research & Education Foundation
🇺🇸Marietta, Georgia, United States
Weiss Memorial Hospital
🇺🇸Chicago, Illinois, United States
Lutheran General Cancer Care Center
🇺🇸Park Ridge, Illinois, United States
Oncology/Hematology Associates of Central Illinois, P.C.
🇺🇸Peoria, Illinois, United States
Michiana Hematology-Oncology
🇺🇸South Bend, Indiana, United States
Cancer Care Center
🇺🇸New Albany, Indiana, United States
Southwest Oncology Associates
🇺🇸Lafayette, Louisiana, United States
Mercy Medical Center
🇺🇸Baltimore, Maryland, United States
APMC
🇺🇸Metairie, Louisiana, United States
Associates in Oncology/Hematology PC
🇺🇸Rockville, Maryland, United States
Chesapeake Oncology-Hematology Associates
🇺🇸Baltimore, Maryland, United States
Providence Cancer Institute
🇺🇸Southfield, Michigan, United States
Berkshire Hematology Oncology, PC
🇺🇸Pittsfield, Massachusetts, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Hematology Oncology Centers of the Northern Rockies
🇺🇸Billings, Montana, United States
Missouri Cancer Associates
🇺🇸Columbia, Missouri, United States
Montana Cancer & Infectious Disease Specialists
🇺🇸Missoula, Montana, United States
Nevada Cancer Center
🇺🇸Las Vegas, Nevada, United States
Orange Medical Group
🇺🇸East Orange, New Jersey, United States
New York Oncology Hematology, P.C., Capital District Hematology Oncology Associates
🇺🇸Albany, New York, United States
VA New Jersey Health Care System
🇺🇸East Orange, New Jersey, United States
University of Medicine & Dentistry of NJ, School of Osteopathic Medicine
🇺🇸Stratford, New Jersey, United States
Overlook Oncology Center
🇺🇸Summit, New Jersey, United States
Hematology-Oncology Associates of Northern NJ, PA
🇺🇸Morristown, New Jersey, United States
Somerset Hematology Oncology Associates
🇺🇸Somerset, New Jersey, United States
San Juan Oncology Associates
🇺🇸Farmington, New Mexico, United States
Erie Medical Center
🇺🇸Buffalo, New York, United States
Cancer Research of Long Island, Inc.
🇺🇸Great Neck, New York, United States
Arena Oncology Associates
🇺🇸Great Neck, New York, United States
Broome Oncology, LLC
🇺🇸Johnson City, New York, United States
Northwest Carolina Oncology and Hematology, P.A.
🇺🇸Hickory, North Carolina, United States
Raleigh Hematology Oncology Clinic
🇺🇸Cary, North Carolina, United States
New York Oncology Hematology, P.C., Riverview Cancer Care Medical Associates
🇺🇸Rexford, New York, United States
University of Cincinnati, Barrett Cancer Center
🇺🇸Cincinnati, Ohio, United States
WJB Dorn VA Medical Center
🇺🇸Columbia, South Carolina, United States
Santee Hematology/Oncology
🇺🇸Sumter, South Carolina, United States
West Texas Cancer Center
🇺🇸Odessa, Texas, United States
Stark MD, PC
🇺🇸Portsmouth, Virginia, United States
Hematology Oncology Patient Enterprises, Center for Cancer Care
🇺🇸Charlottesville, Virginia, United States
Morgantown Internal Medicine Group
🇺🇸Morgantown, West Virginia, United States
Allgemeines offentliches Krankenhaus der barmherzigen Schwestern vom Heiligen Kreuz Pneumologie
🇦🇹Wels, Austria
Sozialmedizinisches Zentrum
🇦🇹Wien, Austria
Humber River Regional Hospital
🇨🇦Weston, Ontario, Canada
Centre Hospitalier du Pays d'Aix
🇫🇷Aix en Provence, Cedex 01, France
Kaiser-Franz-Josef-Spital
🇦🇹Wien, Austria
Centre Hospitalier d'Antibes-Juan-Les-Pins
🇫🇷Antibes Cedex, France
S.M.B.D. Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Hopital de Draguignan
🇫🇷Draguignan, France
DOP International
🇫🇷Creteil, France
Centre Hospitalier General
🇫🇷Gap Cedex, France
Dept. of Internal Medicine, St. Nikolaus-Stiftshospital Andernach
🇩🇪Andernach, Germany
Hopital Saint Antoine
🇫🇷Paris, Cedex 12, France
CHU Hopital St. Marguerite
🇫🇷Marseille, Cedex 09, France
Centre Regional de Lutte contre le Cancer (CRLC), Val d'Aurelle-Paul Lamarque
🇫🇷Montpellier, Cedex 05, France
CHU - Hopital Nord
🇫🇷St. Etienne, Cedex 2, France
Hopital Saint Anne
🇫🇷Toulon Naval, France
Service de Pneumology, Hopital Adulte de Brabois
🇫🇷Vandoeuvre les Nancy, France
Centre Hospitalier
🇫🇷Villefranche sur Soane, France
Ludwig-Maximilians Universitat Munchen
🇩🇪Munchen, Germany
Aesklepios-Fachkliniken Muchen-Gauting
🇩🇪Gauting, Germany
Charite Universitatsklinikum der Humboldt-Universitat zu Berlin
🇩🇪SchumannstraBe, Berlin, Germany
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Krankenhaus GroBhansdorf, Zentrum fur Pneumologie und Thoraxchirurgie
🇩🇪GroBhansdorf, Germany
Hospital Provincial de Castellon
🇪🇸Castellon, Spain
Hospital Universitario La Fe Servicio de Oncologia
🇪🇸Valencia, Spain
Hospital Universitario Doctor Peset
🇪🇸Valencia, Spain
Hospital Clinico Universitario, Servicio Hematologia y Oncologia
🇪🇸Valencia, Spain
Hospital de Sagunto Servicio de Oncologia
🇪🇸Valencia, Spain
Hospital Arnau de Villanova, Servicio de Oncologia
🇪🇸Valencia, Spain
Cancer Centers of Florida, P.A.
🇺🇸Orlando, Florida, United States
Drs. Carroll, Sheth, and Raghavan
🇺🇸Louisville, Kentucky, United States
Louisiana State University Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Charleston Hematology Oncology P.A.
🇺🇸Charleston, South Carolina, United States
South Austin Cancer Center
🇺🇸Austin, Texas, United States
Tulane University Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
University of Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States
Lone Star Oncology Consultants, P.A.
🇺🇸Austin, Texas, United States
Virginia Cancer Institute
🇺🇸Richmond, Virginia, United States
Texas Oncology, P.A.
🇺🇸Garland, Texas, United States