Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer
NCT ID: NCT00050960
Last Updated: 2012-07-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
612 participants
INTERVENTIONAL
2002-05-31
2005-03-31
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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bexarotene with carboplatin and paclitaxel
bexarotene with carboplatin and paclitaxel
bexarotene capsules (400 mg/m\^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.
carboplatin and paclitaxel
carboplatin and paclitaxel
carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\^2) every 3 weeks.
Interventions
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bexarotene with carboplatin and paclitaxel
bexarotene capsules (400 mg/m\^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.
carboplatin and paclitaxel
carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\^2) every 3 weeks.
Eligibility Criteria
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Inclusion Criteria
* Pathologic (histologic or cytologic) confirmation of NSCLC
* Stage IIIB with malignant pleural effusion or Stage IV disease
* At least one measurable or evaluable NSCLC lesion that has not been previously irradiated unless radiation therapy was more than three weeks prior to entry in the study and the lesion has been shown to have progressed subsequent to the radiation therapy
* ECOG performance status 0 or 1
* Adequate organ system function
* Fasting serum triglycerides that are within the age-adjusted normal range (or normalized with appropriate intervention such as antilipid therapy prior to the initiation of Targretin capsule therapy).
Patients must be able to complete at least four cycles of combination chemotherapy (i.e., approximately four months)
Patients must not have had:
* Brain metastasis
* Prior chemotherapy for NSCLC
* Prior platinum-based chemotherapy for any indication
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Eisai, Inc
Principal Investigators
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Mack Mabry, M.D.
Role: STUDY_DIRECTOR
Ligand Pharmaceuticals
Locations
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Montgomery Cancer Center, L.L.C.
Montgomery, Alabama, United States
Arizona Clinical Research Center, Inc.
Tucson, Arizona, United States
Bay Area Cancer Research Group, LLC
Concord, California, United States
Compassionate Cancer Care Medical Group, Inc.
Fountain Valley, California, United States
Pacific Coast Hematology/Oncology Medical Group, Inc.
Fountain Valley, California, United States
California Cancer Care, Inc.
Greenbrae, California, United States
Coast Hematology and Oncology Associates
Long Beach, California, United States
Metropolitan Hematology/Oncology Medical Group
Los Angeles, California, United States
Sant P. Chawla, Inc.
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
Sutter Gould Medical Foundation
Modesto, California, United States
Medical Oncology Care Associates
Orange, California, United States
Southern California Kaiser Permanente Medical Group
San Diego, California, United States
Sharp Health Care
San Diego, California, United States
UCSF/Mount Zion Comprehensive Cancer Center
San Francisco, California, United States
Medical Group of North County, Inc., San Diego Cancer Center
Vista, California, United States
Rocky Mountain Cancer Centers - Midtown
Denver, Colorado, United States
Eastern Connecticut Hematology & Oncology
Norwich, Connecticut, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
Washington Cancer Institute
Washington D.C., District of Columbia, United States
Comprehensive Cancer Care Specialists of Boca Raton
Boca Raton, Florida, United States
University of Florida/Jacksonville
Jacksonville, Florida, United States
Watson Clinic
Lakeland, Florida, United States
Oncology and Radiation Associates
Miami, Florida, United States
Florida Cancer Institute
New Port Richey, Florida, United States
Florida Oncology Associates
Orange Park, Florida, United States
Cancer Centers of Florida, P.A.
Orlando, Florida, United States
South Florida Oncology & Hematology Consultants
Plantation, Florida, United States
Medical Oncology Associates of Augusta
Augusta, Georgia, United States
Georgia Oncology Partners Research & Education Foundation
Marietta, Georgia, United States
St. Luke's/Mountain State Tumor Institute (MSTI)
Boise, Idaho, United States
Weiss Memorial Hospital
Chicago, Illinois, United States
Northwest Oncology and Hematology, SC
Elk Grove Village, 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
Hematology Oncology Assoc. of Illinois
Skokie, Illinois, United States
Central Indiana Cancer Centers
Indianapolis, Indiana, United States
Cancer Care Center
New Albany, Indiana, United States
Michiana Hematology-Oncology
South Bend, Indiana, United States
Kansas City Oncology and Hematology Group, Kansas City Cancer Centers
Overland Park, Kansas, United States
Drs. Carroll, Sheth, and Raghavan
Louisville, Kentucky, United States
Southwest Oncology Associates
Lafayette, Louisiana, United States
APMC
Metairie, Louisiana, United States
Louisiana State University Health Sciences Center
New Orleans, Louisiana, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
Mercy Medical Center
Baltimore, Maryland, United States
Chesapeake Oncology-Hematology Associates
Baltimore, Maryland, United States
Associates in Oncology/Hematology PC
Rockville, Maryland, United States
Berkshire Hematology Oncology, PC
Pittsfield, Massachusetts, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
Providence Cancer Institute
Southfield, Michigan, United States
St. Lukes Hospital
Duluth, Minnesota, United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, United States
Missouri Cancer Associates
Columbia, Missouri, United States
Hematology Oncology Centers of the Northern Rockies
Billings, Montana, United States
Montana Cancer & Infectious Disease Specialists
Missoula, Montana, United States
Cancer and Blood Specialists of Nevada
Henderson, Nevada, United States
Nevada Cancer Center
Las Vegas, Nevada, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Orange Medical Group
East Orange, New Jersey, United States
VA New Jersey Health Care System
East Orange, 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
University of Medicine & Dentistry of NJ, School of Osteopathic Medicine
Stratford, New Jersey, United States
Overlook Oncology Center
Summit, New Jersey, United States
San Juan Oncology Associates
Farmington, New Mexico, United States
New York Oncology Hematology, P.C., Capital District Hematology Oncology Associates
Albany, New York, United States
Erie Medical Center
Buffalo, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Arena Oncology Associates
Great Neck, New York, United States
Cancer Institute of Long Island, Inc.
Great Neck, New York, United States
Cancer Research of Long Island, Inc.
Great Neck, New York, United States
Broome Oncology, LLC
Johnson City, New York, 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
VA Medical Center
Northport, New York, United States
New York Oncology Hematology, P.C., Riverview Cancer Care Medical Associates
Rexford, New York, United States
South Shore Hematology Oncology Associates, PC
Rockville Centre, New York, United States
Raleigh Hematology Oncology Clinic
Cary, North Carolina, United States
Northwest Carolina Oncology and Hematology, P.A.
Hickory, North Carolina, United States
Nashat Y. Gabrail, MD, Inc.
Canton, Ohio, United States
University of Cincinnati, Barrett Cancer Center
Cincinnati, Ohio, United States
Columbus Community Clinical Oncology Program
Columbus, Ohio, United States
Dayton Oncology/Hematology Consultants
Dayton, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Cancer Care Associates - Mercy Campus
Oklahoma City, Oklahoma, United States
Cancer Care Associates
Tulsa, Oklahoma, United States
Oncology/Hematology, Kaiser Permanente Northwest
Portland, Oregon, United States
Oncology Hematology of Lehigh Valley, PC
Bethlehem, Pennsylvania, United States
Medical Oncology Associates of Wyoming Valley, PC
Kingston, Pennsylvania, United States
Charleston Hematology Oncology P.A.
Charleston, South Carolina, United States
Liberty Hematology/Oncology
Columbia, South Carolina, United States
WJB Dorn VA Medical Center
Columbia, South Carolina, United States
Cancer Centers of the Carolinas
Seneca, South Carolina, United States
Santee Hematology/Oncology
Sumter, South Carolina, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, United States
Boston Baskin Cancer Group
Memphis, Tennessee, United States
Texas Oncology, P.A.
Arlington, Texas, United States
South Austin Cancer Center
Austin, Texas, United States
Lone Star Oncology Consultants, P.A.
Austin, Texas, United States
Cancer Specialists of South Texas, PA
Corpus Christi, Texas, United States
Texas Cancer Center at Medical City
Dallas, Texas, United States
Texas Oncology, P.A.
Dallas, Texas, United States
Texas Oncology, P.A.
Fort Worth, Texas, United States
Texas Oncology, P.A.
Garland, Texas, United States
University of Texas, MD Anderson Cancer Center
Houston, Texas, United States
Allison Cancer Center
Midland, Texas, United States
West Texas Cancer Center
Odessa, Texas, United States
Hope Oncology
Richardson, Texas, United States
Hematology & Oncology Associates of South Texas
San Antonio, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
Texoma Cancer Center
Wichita Falls, Texas, United States
Utah Cancer Specialists
Salt Lake City, Utah, United States
Arlington Fairfax Hematology Oncology
Arlington, Virginia, United States
Hematology Oncology Patient Enterprises, Center for Cancer Care
Charlottesville, Virginia, United States
Danville Hematology & Oncology, Inc.
Danville, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Stark MD, PC
Portsmouth, Virginia, United States
Virginia Cancer Institute
Richmond, Virginia, United States
Yakima Regional Cancer Care Center, Internal Medicine Associates of Yakima, Inc.
Yakima, Washington, United States
Morgantown Internal Medicine Group
Morgantown, West Virginia, United States
Sozialmedizinisches Zentrum
Vienna, , Austria
Kaiser-Franz-Josef-Spital
Vienna, , Austria
Allgemeines offentliches Krankenhaus der barmherzigen Schwestern vom Heiligen Kreuz Pneumologie
Wels, , Austria
Algoma Regional Cancer Program - Sault Area Hospital
Sault Ste. Marie, Ontario, Canada
Humber River Regional Hospital
Weston, Ontario, Canada
S.M.B.D. Jewish General Hospital
Montreal, Quebec, Canada
Centre Hospitalier du Pays d'Aix
Aix-en-Provence, , France
Centre Hospitalier General de la Region Annecienne
Annecy, , France
Centre Hospitalier d'Antibes-Juan-Les-Pins
Antibes, , France
CHRU Hopital de Bois Guillaume
Bois-Guillaume, , France
DOP International
Créteil, , France
Hopital de Draguignan
Draguignan, , France
Centre Hospitalier General
Gap, , France
Hopital du Cluzeau
Limoges, , France
CHU Hopital St. Marguerite
Marseille, , France
Centre Regional de Lutte contre le Cancer (CRLC), Val d'Aurelle-Paul Lamarque
Montpellier, , France
Hopital Saint Antoine
Paris, , France
CHU - Hopital Nord
Saint-Etienne, , France
Hopital Saint Anne
Toulon Naval, , France
Service de Pneumology, Hopital Adulte de Brabois
Vandœuvre-lès-Nancy, , France
Centre Hospitalier
Villefranche Sur Soane, , France
Dept. of Internal Medicine, St. Nikolaus-Stiftshospital Andernach
Andernach, , Germany
Aesklepios-Fachkliniken Muchen-Gauting
Gauting, , Germany
Krankenhaus GroBhansdorf, Zentrum fur Pneumologie und Thoraxchirurgie
GroBhansdorf, , Germany
Ludwig-Maximilians Universitat Munchen
München, , Germany
Charite Universitatsklinikum der Humboldt-Universitat zu Berlin
SchumannstraBe, Berlin, , Germany
Hospital Provincial de Castellon
Castellon, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario Doctor Peset
Valencia, , Spain
Hospital Universitario La Fe Servicio de Oncologia
Valencia, , Spain
Hospital Arnau de Villanova, Servicio de Oncologia
Valencia, , Spain
Hospital Clinico Universitario, Servicio Hematologia y Oncologia
Valencia, , Spain
Hospital de Sagunto Servicio de Oncologia
Valencia, , Spain
Countries
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Related Links
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Related Info
Other Identifiers
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L1069-48
Identifier Type: -
Identifier Source: org_study_id
NCT00036907
Identifier Type: -
Identifier Source: nct_alias