Ligand Pharmaceuticals Inc. is studying the use of Targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic non-small cell lung cancer in patients who have not yet received chemotherapy for their lung cancer.

Condition	Treatment or Intervention	Phase
Non-small cell lung cancer	Drug: Targretin capsules	Phase III

Further Study Details: 

Expected Total Enrollment:  600

Ligand Pharmaceuticals Inc. is studying 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. In these studies, 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.

Genders Eligible for Study:  Both

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

Alabama
      Montgomery Cancer Center, L.L.C., Montgomery,  Alabama,  36106,  United States
Arizona
      Arizona Clinical Research Center, Inc., Tucson,  Arizona,  85712,  United States
California
      Sutter Gould Medical Foundation, Modesto,  California,  95355,  United States
      Sharp Health Care, San Diego,  California,  92123,  United States
      Sant P. Chawla, Inc., Los Angeles,  California,  90067,  United States
      California Cancer Care, Inc., Greenbrae,  California,  94909,  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
      Metropolitan Hematology/Oncology Medical Group, Los Angeles,  California,  90057,  United States
      Southern California Kaiser Permanente Medical Group, San Diego,  California,  92120,  United States
      Medical Group of North County, Inc., San Diego Cancer Center, Vista,  California,  92083,  United States
      Medical Oncology Care Associates, Orange,  California,  92868,  United States
      Bay Area Cancer Research Group, LLC, Concord,  California,  94520,  United States
      UCSF/Mount Zion Comprehensive Cancer Center, San Francisco,  California,  94115,  United States
      Coast Hematology and Oncology Associates, Long Beach,  California,  90806,  United States
      UCLA Medical Center, Los Angeles,  California,  94115,  United States
Colorado
      Rocky Mountain Cancer Centers - Midtown, Denver,  Colorado,  80218,  United States
Connecticut
      Eastern Connecticut Hematology & Oncology, Norwich,  Connecticut,  06360,  United States
District of Columbia
      Georgetown University Hospital, Washington,  District of Columbia,  20007,  United States
      Washington Cancer Institute, Washington,  District of Columbia,  20010,  United States
Florida
      Oncology and Radiation Associates, Miami,  Florida,  33133,  United States
      University of Florida/Jacksonville, Jacksonville,  Florida,  32209,  United States
      Florida Oncology Associates, Orange Park,  Florida,  32073,  United States
      Florida Cancer Institute, New Port Richey,  Florida,  34652,  United States
      Comprehensive Cancer Care Specialists of Boca Raton, Boca Raton,  Florida,  33428,  United States
      Watson Clinic, Lakeland,  Florida,  33805,  United States
      Cancer Centers of Florida, P.A., Orlando,  Florida,  32806,  United States
      South Florida Oncology & Hematology Consultants, Plantation,  Florida,  33324,  United States
Georgia
      Medical Oncology Associates of Augusta, Augusta,  Georgia,  30901,  United States
      Georgia Oncology Partners Research & Education Foundation, Marietta,  Georgia,  30060,  United States
Idaho
      St. Luke's/Mountain State Tumor Institute (MSTI), Boise,  Idaho,  83712,  United States
Illinois
      Lutheran General Cancer Care Center, Park Ridge,  Illinois,  60068,  United States
      Northwest Oncology and Hematology, SC, Elk Grove Village,  Illinois,  60007,  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
      Weiss Memorial Hospital, Chicago,  Illinois,  60640,  United States
Indiana
      Cancer Care Center, New Albany,  Indiana,  47150,  United States
      Michiana Hematology-Oncology, South Bend,  Indiana,  46601,  United States
      Central Indiana Cancer Centers, Indianapolis,  Indiana,  46227,  United States
Kansas
      Kansas City Oncology and Hematology Group, Kansas City Cancer Centers, Overland Park,  Kansas,  66210,  United States
Kentucky
      Drs. Carroll, Sheth, and Raghavan, Louisville,  Kentucky,  40215,  United States
Louisiana
      APMC, Metairie,  Louisiana,  70006,  United States
      Southwest Oncology Associates, Lafayette,  Louisiana,  70503,  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
Maryland
      Chesapeake Oncology-Hematology Associates, Baltimore,  Maryland,  21225,  United States
      Mercy Medical Center, Baltimore,  Maryland,  21202,  United States
      Associates in Oncology/Hematology PC, Rockville,  Maryland,  20850,  United States
Massachusetts
      Berkshire Hematology Oncology, PC, Pittsfield,  Massachusetts,  01201,  United States
Michigan
      Providence Cancer Institute, Southfield,  Michigan,  48075,  United States
      University of Michigan Medical Center, Ann Arbor,  Michigan,  48109,  United States
Minnesota
      St. Lukes Hospital, Duluth,  Minnesota,  55805,  United States
      Minnesota Oncology Hematology, P.A., Minneapolis,  Minnesota,  55407,  United States
Missouri
      Missouri Cancer Associates, Columbia,  Missouri,  65201,  United States
Montana
      Montana Cancer & Infectious Disease Specialists, Missoula,  Montana,  59802,  United States
      Hematology Oncology Centers of the Northern Rockies, Billings,  Montana,  59101,  United States
Nevada
      Cancer and Blood Specialists of Nevada, Henderson,  Nevada,  89014,  United States
      Nevada Cancer Center, Las Vegas,  Nevada,  89109,  United States
      Nevada Cancer Center, Las Vegas,  Nevada,  89109,  United States
New Hampshire
      Dartmouth-Hitchcock Medical Center, Lebanon,  New Hampshire,  03756,  United States
New Jersey
      Orange Medical Group, East Orange,  New Jersey,  07018,  United States
      VA New Jersey Health Care System, East Orange,  New Jersey,  07018,  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
      Hematology-Oncology Associates of Northern NJ, PA, Morristown,  New Jersey,  07962,  United States
New Mexico
      San Juan Oncology Associates, Farmington,  New Mexico,  87401,  United States
New York
      Arena Oncology Associates, Great Neck,  New York,  11021,  United States
      Erie Medical Center, Buffalo,  New York,  14215,  United States
      New York Oncology Hematology, P.C., Capital District Hematology Oncology Associates, Albany,  New York,  12208,  United States
      Columbia Presbyterian Medical Center, New York,  New York,  10032,  United States
      New York Presbyterian Hospital, Weill Medical College of Cornell University, New York,  New York,  10021,  United States
      Roswell Park Cancer Institute, Buffalo,  New York,  14263,  United States
      Cancer Research of Long Island, Inc., Great Neck,  New York,  11023,  United States
      New York Oncology Hematology, P.C., Riverview Cancer Care Medical Associates, Rexford,  New York,  12148,  United States
      Cancer Institute of Long Island, Inc., Great Neck,  New York,  11023,  United States
      Broome Oncology, LLC, Johnson City,  New York,  13790,  United States
      VA Medical Center, Northport,  New York,  11768,  United States
      South Shore Hematology Oncology Associates, PC, Rockville Centre,  New York,  11570,  United States
North Carolina
      Northwest Carolina Oncology and Hematology, P.A., Hickory,  North Carolina,  28602,  United States
      Raleigh Hematology Oncology Clinic, Cary,  North Carolina,  27511,  United States
Ohio
      Nashat Y. Gabrail, MD, Inc., Canton,  Ohio,  44718,  United States
      Dayton Oncology/Hematology Consultants, Dayton,  Ohio,  45439,  United States
      Columbus Community Clinical Oncology Program, Columbus,  Ohio,  43206,  United States
      University of Cincinnati, Barrett Cancer Center, Cincinnati,  Ohio,  45219,  United States
Oklahoma
      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
Oregon
      Oncology/Hematology, Kaiser Permanente Northwest, Portland,  Oregon,  97227,  United States
Pennsylvania
      Oncology Hematology of Lehigh Valley, PC, Bethlehem,  Pennsylvania,  18015,  United States
      Medical Oncology Associates of Wyoming Valley, PC, Kingston,  Pennsylvania,  18704,  United States
South Carolina
      Santee Hematology/Oncology, Sumter,  South Carolina,  29150,  United States
      WJB Dorn VA Medical Center, Columbia,  South Carolina,  29209,  United States
      Liberty Hematology/Oncology, Columbia,  South Carolina,  29203,  United States
      Cancer Centers of the Carolinas, Seneca,  South Carolina,  29672,  United States
      Charleston Hematology Oncology P.A., Charleston,  South Carolina,  29403,  United States
Tennessee
      Thompson Cancer Survival Center, Knoxville,  Tennessee,  37916,  United States
      Boston Baskin Cancer Group, Memphis,  Tennessee,  38104,  United States
Texas
      University of Texas, MD Anderson Cancer Center, Houston,  Texas,  77030,  United States
      Lone Star Oncology Consultants, P.A., Austin,  Texas,  78759,  United States
      Hope Oncology, Richardson,  Texas,  75080,  United States
      Hematology & Oncology Associates of South Texas, San Antonio,  Texas,  78229,  United States
      Cancer Specialists of South Texas, PA, Corpus Christi,  Texas,  78412,  United States
      Texas Oncology, P.A., Arlington,  Texas,  76012,  United States
      Texas Oncology, P.A., Dallas,  Texas,  75246,  United States
      South Austin Cancer Center, Austin,  Texas,  78745,  United States
      Texas Cancer Center at Medical City, Dallas,  Texas,  75230,  United States
      West Texas Cancer Center, Odessa,  Texas,  79761,  United States
      Texas Oncology, P.A., Garland,  Texas,  75042,  United States
      Tyler Cancer Center, Tyler,  Texas,  75702,  United States
      Texas Oncology, P.A., Fort Worth,  Texas,  76104,  United States
      Texoma Cancer Center, Wichita Falls,  Texas,  76310,  United States
      Allison Cancer Center, Midland,  Texas,  79701,  United States
Utah
      Utah Cancer Specialists, Salt Lake City,  Utah,  84106,  United States
Virginia
      Danville Hematology & Oncology, Inc., Danville,  Virginia,  24541,  United States
      Virginia Cancer Institute, Richmond,  Virginia,  23230,  United States
      Arlington Fairfax Hematology Oncology, Arlington,  Virginia,  22205,  United States
      Stark MD, PC, Portsmouth,  Virginia,  23707,  United States
      Hematology Oncology Patient Enterprises, Center for Cancer Care, Charlottesville,  Virginia,  22902,  United States
      Virginia Oncology Associates, Norfolk,  Virginia,  23502,  United States
Washington
      Yakima Regional Cancer Care Center, Internal Medicine Associates of Yakima, Inc., Yakima,  Washington,  98902,  United States
West Virginia
      Morgantown Internal Medicine Group, Morgantown,  West Virginia,  26505,  United States
Austria
      Kaiser-Franz-Josef-Spital, Wien,  A-1100,  Austria
      Allgemeines offentliches Krankenhaus der barmherzigen Schwestern vom Heiligen Kreuz Pneumologie, Wels,  4600,  Austria
      Sozialmedizinisches Zentrum, Wien,  1145,  Austria
Canada, Ontario
      Algoma Regional Cancer Program - Sault Area Hospital, Sault Ste. Marie,  Ontario,  P6A 2C4,  Canada
      Humber River Regional Hospital, Weston,  Ontario,  M9N 1N8,  Canada
Canada, Quebec
      S.M.B.D. Jewish General Hospital, Montreal,  Quebec,  H3T 1E2,  Canada
France
      Centre Hospitalier General de la Region Annecienne, Annecy Cedex,  47011,  France
      DOP International, Creteil,  94010,  France
      Hopital Saint Anne, Toulon Naval,  83800,  France
      Centre Hospitalier, Villefranche sur Soane,  69655,  France
      CHU - Hopital Nord, St. Etienne, Cedex 2,  42055,  France
      CHRU Hopital de Bois Guillaume, Bois-Guillaume,  76230,  France
      Centre Hospitalier du Pays d'Aix, Aix en Provence, Cedex 01,  13616,  France
      Service de Pneumology, Hopital Adulte de Brabois, Vandoeuvre-les-Nancy,  54511,  France
      Hopital Saint Antoine, Paris, Cedex 12,  75571,  France
      Centre Hospitalier d'Antibes-Juan-Les-Pins, Antibes Cedex,  06606,  France
      Hopital de Draguignan, Draguignan,  83300,  France
      Centre Regional de Lutte contre le Cancer (CRLC), Val d'Aurelle-Paul Lamarque, Montpellier, Cedex 05,  34298,  France
      Centre Hospitalier General, Gap Cedex,  05007,  France
      Hopital du Cluzeau, Limoges Cedex,  87042,  France
      CHU Hopital St. Marguerite, Marseille Cedex 09,  29274,  France
Germany
      Aesklepios-Fachkliniken Muchen-Gauting, Gauting,  D-82131,  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
      Dept. of Internal Medicine, St. Nikolaus-Stiftshospital Andernach, Andernach,  D-56626,  Germany
Spain
      Hospital Universitario Doctor Peset, Valencia,  46 017,  Spain
      Hospital Clinico Universitario, Servicio Hematologia y Oncologia, Valencia,  46044,  Spain
      Hospital de Sagunto Servicio de Oncologia, Valencia,  46520,  Spain
      Hospital Arnau de Villanova, Servicio de Oncologia, Valencia,  46039,  Spain
      Hospital Universitario La Fe Servicio de Oncologia, Valencia,  46018,  Spain
      Hospital Clinico San Carlos, Madrid,  28040,  Spain
      Hospital Provincial de Castellon, Castellon,  12002,  Spain

Study chairs or principal investigators

Mack Mabry, M.D.,  Study Director,  Ligand Pharmaceuticals   

Study ID Numbers:  L1069-48
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  December 31, 2002
ClinicalTrials.gov Identifier:  NCT00050960
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08