Lung Cancer Clinical Trial

Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

Patients must have:

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

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

612

Study ID:

NCT00050960

Recruitment Status:

Completed

Sponsor:

Eisai Inc.

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There are 149 Locations for this study

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Montgomery Cancer Center, L.L.C.
Montgomery Alabama, 36106, United States
Arizona Clinical Research Center, Inc.
Tucson Arizona, 85712, United States
Bay Area Cancer Research Group, LLC
Concord California, 94520, United States
Compassionate Cancer Care Medical Group, Inc.
Fountain Valley California, 92708, United States
Pacific Coast Hematology/Oncology Medical Group, Inc.
Fountain Valley California, 92708, United States
California Cancer Care, Inc.
Greenbrae California, 94909, United States
Coast Hematology and Oncology Associates
Long Beach California, 90806, United States
Metropolitan Hematology/Oncology Medical Group
Los Angeles California, 90057, United States
Sant P. Chawla, Inc.
Los Angeles California, 90067, United States
UCLA Medical Center
Los Angeles California, 94115, United States
Sutter Gould Medical Foundation
Modesto California, 95355, United States
Medical Oncology Care Associates
Orange California, 92868, United States
Southern California Kaiser Permanente Medical Group
San Diego California, 92120, United States
Sharp Health Care
San Diego California, 92123, United States
UCSF/Mount Zion Comprehensive Cancer Center
San Francisco California, 94115, United States
Medical Group of North County, Inc., San Diego Cancer Center
Vista California, 92083, United States
Rocky Mountain Cancer Centers - Midtown
Denver Colorado, 80218, United States
Eastern Connecticut Hematology & Oncology
Norwich Connecticut, 06360, United States
Georgetown University Hospital
Washington District of Columbia, 20007, United States
Washington Cancer Institute
Washington District of Columbia, 20010, United States
Comprehensive Cancer Care Specialists of Boca Raton
Boca Raton Florida, 33428, United States
University of Florida/Jacksonville
Jacksonville Florida, 32209, United States
Watson Clinic
Lakeland Florida, 33805, United States
Oncology and Radiation Associates
Miami Florida, 33133, United States
Florida Cancer Institute
New Port Richey Florida, 34652, United States
Florida Oncology Associates
Orange Park Florida, 32073, United States
Cancer Centers of Florida, P.A.
Orlando Florida, 32806, United States
South Florida Oncology & Hematology Consultants
Plantation Florida, 33324, United States
Medical Oncology Associates of Augusta
Augusta Georgia, 30901, United States
Georgia Oncology Partners Research & Education Foundation
Marietta Georgia, 30060, United States
St. Luke's/Mountain State Tumor Institute (MSTI)
Boise Idaho, 83712, United States
Weiss Memorial Hospital
Chicago Illinois, 60640, United States
Northwest Oncology and Hematology, SC
Elk Grove Village Illinois, 60007, United States
Lutheran General Cancer Care Center
Park Ridge Illinois, 60068, United States
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria Illinois, 61602, United States
Hematology Oncology Assoc. of Illinois
Skokie Illinois, 60077, United States
Central Indiana Cancer Centers
Indianapolis Indiana, 46227, United States
Cancer Care Center
New Albany Indiana, 47150, United States
Michiana Hematology-Oncology
South Bend Indiana, 46601, United States
Kansas City Oncology and Hematology Group, Kansas City Cancer Centers
Overland Park Kansas, 66210, United States
Drs. Carroll, Sheth, and Raghavan
Louisville Kentucky, 40215, United States
Southwest Oncology Associates
Lafayette Louisiana, 70503, United States
APMC
Metairie Louisiana, 70006, United States
Louisiana State University Health Sciences Center
New Orleans Louisiana, 70112, United States
Tulane University Health Sciences Center
New Orleans Louisiana, 70112, United States
Mercy Medical Center
Baltimore Maryland, 21202, United States
Chesapeake Oncology-Hematology Associates
Baltimore Maryland, 21225, United States
Associates in Oncology/Hematology PC
Rockville Maryland, 20850, United States
Berkshire Hematology Oncology, PC
Pittsfield Massachusetts, 01201, United States
University of Michigan Medical Center
Ann Arbor Michigan, 48109, United States
Providence Cancer Institute
Southfield Michigan, 48075, United States
St. Lukes Hospital
Duluth Minnesota, 55805, United States
Minnesota Oncology Hematology, P.A.
Minneapolis Minnesota, 55407, United States
Missouri Cancer Associates
Columbia Missouri, 65201, United States
Hematology Oncology Centers of the Northern Rockies
Billings Montana, 59101, United States
Montana Cancer & Infectious Disease Specialists
Missoula Montana, 59802, United States
Cancer and Blood Specialists of Nevada
Henderson Nevada, 89014, United States
Nevada Cancer Center
Las Vegas Nevada, 89109, United States
Dartmouth-Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
Orange Medical Group
East Orange New Jersey, 07018, United States
VA New Jersey Health Care System
East Orange New Jersey, 07018, United States
Hematology-Oncology Associates of Northern NJ, PA
Morristown New Jersey, 07962, United States
Somerset Hematology Oncology Associates
Somerset New Jersey, 08873, United States
University of Medicine & Dentistry of NJ, School of Osteopathic Medicine
Stratford New Jersey, 08084, United States
Overlook Oncology Center
Summit New Jersey, 07901, United States
San Juan Oncology Associates
Farmington New Mexico, 87401, United States
New York Oncology Hematology, P.C., Capital District Hematology Oncology Associates
Albany New York, 12208, United States
Erie Medical Center
Buffalo New York, 14215, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Arena Oncology Associates
Great Neck New York, 11021, United States
Cancer Institute of Long Island, Inc.
Great Neck New York, 11023, United States
Cancer Research of Long Island, Inc.
Great Neck New York, 11023, United States
Broome Oncology, LLC
Johnson City New York, 13790, United States
New York Presbyterian Hospital, Weill Medical College of Cornell University
New York New York, 10021, United States
Columbia Presbyterian Medical Center
New York New York, 10032, United States
VA Medical Center
Northport New York, 11768, United States
New York Oncology Hematology, P.C., Riverview Cancer Care Medical Associates
Rexford New York, 12148, United States
South Shore Hematology Oncology Associates, PC
Rockville Centre New York, 11570, United States
Raleigh Hematology Oncology Clinic
Cary North Carolina, 27511, United States
Northwest Carolina Oncology and Hematology, P.A.
Hickory North Carolina, 28602, United States
Nashat Y. Gabrail, MD, Inc.
Canton Ohio, 44718, United States
University of Cincinnati, Barrett Cancer Center
Cincinnati Ohio, 45219, United States
Columbus Community Clinical Oncology Program
Columbus Ohio, 43206, United States
Dayton Oncology/Hematology Consultants
Dayton Ohio, 45439, United States
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
Cancer Care Associates - Mercy Campus
Oklahoma City Oklahoma, 73120, United States
Cancer Care Associates
Tulsa Oklahoma, 74136, United States
Oncology/Hematology, Kaiser Permanente Northwest
Portland Oregon, 97227, United States
Oncology Hematology of Lehigh Valley, PC
Bethlehem Pennsylvania, 18015, United States
Medical Oncology Associates of Wyoming Valley, PC
Kingston Pennsylvania, 18704, United States
Charleston Hematology Oncology P.A.
Charleston South Carolina, 29403, United States
Liberty Hematology/Oncology
Columbia South Carolina, 29203, United States
WJB Dorn VA Medical Center
Columbia South Carolina, 29209, United States
Cancer Centers of the Carolinas
Seneca South Carolina, 29672, United States
Santee Hematology/Oncology
Sumter South Carolina, 29150, United States
Thompson Cancer Survival Center
Knoxville Tennessee, 37916, United States
Boston Baskin Cancer Group
Memphis Tennessee, 38104, United States
Texas Oncology, P.A.
Arlington Texas, 76012, United States
South Austin Cancer Center
Austin Texas, 78745, United States
Lone Star Oncology Consultants, P.A.
Austin Texas, 78759, United States
Cancer Specialists of South Texas, PA
Corpus Christi Texas, 78412, United States
Texas Cancer Center at Medical City
Dallas Texas, 75230, United States
Texas Oncology, P.A.
Dallas Texas, 75246, United States
Texas Oncology, P.A.
Fort Worth Texas, 76104, United States
Texas Oncology, P.A.
Garland Texas, 75042, United States
University of Texas, MD Anderson Cancer Center
Houston Texas, 77030, United States
Allison Cancer Center
Midland Texas, 79701, United States
West Texas Cancer Center
Odessa Texas, 79761, United States
Hope Oncology
Richardson Texas, 75080, United States
Hematology & Oncology Associates of South Texas
San Antonio Texas, 78229, United States
Tyler Cancer Center
Tyler Texas, 75702, United States
Texoma Cancer Center
Wichita Falls Texas, 76310, United States
Utah Cancer Specialists
Salt Lake City Utah, 84106, United States
Arlington Fairfax Hematology Oncology
Arlington Virginia, 22205, United States
Hematology Oncology Patient Enterprises, Center for Cancer Care
Charlottesville Virginia, 22902, United States
Danville Hematology & Oncology, Inc.
Danville Virginia, 24541, United States
Virginia Oncology Associates
Norfolk Virginia, 23502, United States
Stark MD, PC
Portsmouth Virginia, 23707, United States
Virginia Cancer Institute
Richmond Virginia, 23230, United States
Yakima Regional Cancer Care Center, Internal Medicine Associates of Yakima, Inc.
Yakima Washington, 98902, United States
Morgantown Internal Medicine Group
Morgantown West Virginia, 26505, United States
Allgemeines offentliches Krankenhaus der barmherzigen Schwestern vom Heiligen Kreuz Pneumologie
Wels , 4600, Austria
Sozialmedizinisches Zentrum
Wien , 1145, Austria
Kaiser-Franz-Josef-Spital
Wien , A-110, Austria
Algoma Regional Cancer Program - Sault Area Hospital
Sault Ste. Marie Ontario, P6A 2, Canada
Humber River Regional Hospital
Weston Ontario, M9N 1, Canada
S.M.B.D. Jewish General Hospital
Montreal Quebec, H3T 1, Canada
Centre Hospitalier du Pays d'Aix
Aix en Provence, Cedex 01 , 13616, France
Centre Hospitalier General de la Region Annecienne
Annecy Cedex , 47011, France
Centre Hospitalier d'Antibes-Juan-Les-Pins
Antibes Cedex , 06606, France
CHRU Hopital de Bois Guillaume
Bois Guillaume , 76230, France
DOP International
Creteil , 94010, France
Hopital de Draguignan
Draguignan , 83300, France
Centre Hospitalier General
Gap Cedex , 05007, France
Hopital du Cluzeau
Limoges Cedex , 87042, France
CHU Hopital St. Marguerite
Marseille, Cedex 09 , 29274, France
Centre Regional de Lutte contre le Cancer (CRLC), Val d'Aurelle-Paul Lamarque
Montpellier, Cedex 05 , 34298, France
Hopital Saint Antoine
Paris, Cedex 12 , 75571, France
CHU - Hopital Nord
St. Etienne, Cedex 2 , 42055, France
Hopital Saint Anne
Toulon Naval , 83800, France
Service de Pneumology, Hopital Adulte de Brabois
Vandoeuvre les Nancy , 54511, France
Centre Hospitalier
Villefranche sur Soane , 69655, France
Dept. of Internal Medicine, St. Nikolaus-Stiftshospital Andernach
Andernach , D-566, Germany
Aesklepios-Fachkliniken Muchen-Gauting
Gauting , D-821, Germany
Krankenhaus GroBhansdorf, Zentrum fur Pneumologie und Thoraxchirurgie
GroBhansdorf , 22927, Germany
Ludwig-Maximilians Universitat Munchen
Munchen , 80336, Germany
Charite Universitatsklinikum der Humboldt-Universitat zu Berlin
SchumannstraBe, Berlin , 10117, Germany
Hospital Provincial de Castellon
Castellon , 12002, Spain
Hospital Clinico San Carlos
Madrid , 28040, Spain
Hospital Universitario Doctor Peset
Valencia , 46 01, Spain
Hospital Universitario La Fe Servicio de Oncologia
Valencia , 46018, Spain
Hospital Arnau de Villanova, Servicio de Oncologia
Valencia , 46039, Spain
Hospital Clinico Universitario, Servicio Hematologia y Oncologia
Valencia , 46044, Spain
Hospital de Sagunto Servicio de Oncologia
Valencia , 46520, Spain

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

612

Study ID:

NCT00050960

Recruitment Status:

Completed

Sponsor:


Eisai Inc.

How clear is this clinincal trial information?

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