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: bexarotene	Phase III

Further Study Details: 

Expected Total Enrollment:  600

Ligand Pharmaceuticals Inc. is studying the use of Targretin capsules (bexarotene) in combination with Cisplatin and Vinorelbine 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 four 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
      Brookwood Medical Center, Birmingham,  Alabama,  35209,  United States
Arizona
      Southern Arizona VA Healthcare System, Tucson,  Arizona,  85723,  United States
California
      Arroyo Research Inc., Pasadena,  California,  91105,  United States
      Desert Hematology-Oncology Medical Group, Inc., Rancho Mirage,  California,  92270,  United States
Florida
      New Hope Cancer Center, Hudson,  Florida,  34667,  United States
      University of Florida, Gainsville,  Florida,  32610,  United States
      Bay Area Cancer Consultants, Palm Harbor,  Florida,  34684,  United States
      Veterans Affairs Medical Center, Miami,  Florida,  33125,  United States
Illinois
      Northwest Medical Specialists, Arlington Heights,  Illinois,  60004,  United States
Louisiana
      Jayne Gurtler, M.D., APMC, Metairie,  Louisiana,  70006,  United States
      Louisiana State University Health Science Center, New Orleans,  Louisiana,  70112,  United States
Michigan
      St. Joseph Mercy Oakland Hospital, Pontiac,  Michigan,  48341,  United States
Missouri
      Capitol Comprehensive Cancer Care Clinic, Jefferson City,  Missouri,  65109,  United States
New York
      SUNY Downstate Medical Center, Brooklyn,  New York,  11203,  United States
      VA Western New York Health Care System, Buffalo,  New York,  14215,  United States
Ohio
      Hematology-Oncology Associates, Toledo,  Ohio,  43623,  United States
Oklahoma
      Tariq Mahmood, Midwest City,  Oklahoma,  73110,  United States
Tennessee
      University Oncology & Hematology Associates, Chattanooga,  Tennessee,  37404,  United States
Wisconsin
      Marshfield Medical Research Foundation, Marshfield,  Wisconsin,  54449,  United States
      Medical Associates Health Centers, Menomonee Falls,  Wisconsin,  53051,  United States
Australia, Australian Capital Territory
      Canberra Hospital, Garran,  Australian Capital Territory,  2605,  Australia
Australia, New South Wales
      Port Macquarie Base Hospital, Port Macquarie,  New South Wales,  2444,  Australia
      Southern Medical Daycare Centre, Wollongong,  New South Wales,  2500,  Australia
Australia, South Australia
      Burnside War Memorial Hospital, Toorak Gardens,  South Australia,  5065,  Australia
      Queen Elizabeth Hospital, Woodville,  South Australia,  5011,  Australia
Australia, Tasmania
      Royal Hobart Hospital, Hobart,  Tasmania,  7001,  Australia
Australia, Victoria
      Box Hill Hospital, Box Hill,  Victoria,  3128,  Australia
      Border Medical Oncology, Wodonga,  Victoria,  3690,  Australia
Canada, Alberta
      Tom Baker Cancer Centre, Calgary,  Alberta,  T2N 4N2,  Canada
Canada, Manitoba
      Cancer Care Manitoba, Winnepeg,  Manitoba,  R3E 0V9,  Canada
Canada, Nova Scotia
      QEII Health Sciences Center, Halifax,  Nova Scotia,  B3H 1V7,  Canada
Canada, Ontario
      Ottawa Regional Cancer Centre, Ottawa,  Ontario,  K1H 1C4,  Canada
Czech Republic
      Nemocnice odd. Onkologie, Ceske Budejovice,  370 87,  Czech Republic
      Pneumologicka klinika 1. LF UK, Praha-6-Veleslavin,  CZ-160 00,  Czech Republic
      Klinika pneumologie a hrudni chirurgie 3.LF, Praha-8,  CZ-180 00,  Czech Republic
France, Cedex
      Centre Hospitalier Francois Maillot, Briey,  Cedex,  54150,  France
      Centre Hospitalier General de Belfort, Belfort,  Cedex,  90016,  France
      Centre Hospitalier Intercommunal de la Haute-Saone, Vesoul,  Cedex,  70014,  France
      Institut Jean Godinot, Reims,  Cedex,  51100,  France
Greece
      University Hospital of Patras, Rio,  26500,  Greece
      7th Pneumonology Clinic, Sotiria Hospital for Diseases of the Chest, Athens,  11527,  Greece
      6th Pneumonology Department, Sotiria Hospital for Diseases of the Chest, Athens,  11527,  Greece
Greece, Alexandroupolis
      University Hospital of Alexandroupolis, Dragana,  Alexandroupolis,  68100,  Greece
Greece, Crete
      University General Hospital of Heraklion, Heraklion,  Crete,  Greece
Greece, Thessaloniki
      1st Pulmonary Clinic of G. Papanikolaou Hospital, Exochi,  Thessaloniki,  57010,  Greece
      2nd Pulmonary Clinic of G. Papanikolaou Hospital, Exochi,  Thessaloniki,  57010,  Greece
Hungary
      Fovarosi Onkormanyzat Uzsoki utcai, Korhaza, Budapest,  1145,  Hungary
      Koranyi National Institute for Pulmonology, Budapest,  1529,  Hungary
      Csongrad Megyei Onkormanyzat Mellkasi, Deszk,  6772,  Hungary
      Semmelweis University Department of Pulmonology, Budapest,  1125,  Hungary
Israel
      Barzilai Medical Centre, Ashkelon,  78308,  Israel
      Kaplan Medical Center, Rehovot,  76100,  Israel
      Assaf Harofeh Medical Center, Zerifin,  70300,  Israel
      Meir Hospital, Kfar Sava,  44281,  Israel
      Hadassah Medical Center, Jerusalem,  19200,  Israel
      Sheba Medical Center, Tel Hashomer,  52620,  Israel
      Tel-Aviv Sovrasky Medical Center, Tel Aviv,  64239,  Israel
Poland
      Akademii Medycznej w Gdansku, Gdansk,  80-216,  Poland
      Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Krakow,  31-115,  Poland
      Wielkopolskie Centrum Chorob Pluc I Gruzlicy, Poznan,  66-569,  Poland
      Instytut Gruzlicy i Chorob Pluc, Warsaw,  01-138,  Poland
      Regionalne Centrum Onkologii, Bialystok,  15-027,  Poland
Russian Federation
      Research Institute of Oncology n.a. Hertzen, Moscow,  12584,  Russian Federation
      City Oncology Clinical Center, Moscow,  107005,  Russian Federation
      Central Clinical Hospital n.a. Semashko, Moscow,  129128,  Russian Federation
      Russian Oncology Research Center n.a. Blokhin, Moscow,  115478,  Russian Federation
      City Oncology Hospital #62, Moscow,  143423,  Russian Federation
      City Oncology Center, St Petersburg,  197022,  Russian Federation
      Research Institute of Oncology n.a. Petrov, St Petersburg,  197758,  Russian Federation
      St. Petersburg Pavlov State Medical University, St Petersburg,  197089,  Russian Federation
      Arkhangelsk Regional Oncology Center, Arkhangelsk,  163045,  Russian Federation
United Kingdom, Aberdeen
      Aberdeen Royal Infirmary, Foresterhill,  Aberdeen,  AB25 2ZN,  United Kingdom
United Kingdom, England
      Chelsea & Westminster Hospital, London,  England,  SW10 9NH,  United Kingdom
      Bristol Hematology and Oncology Centre, Bristol,  England,  BS2 8ED,  United Kingdom
      Guys & St. Thomas' Cancer Centre, London,  England,  SE1 9RT,  United Kingdom
      Leicester Royal Infirmary, Leicester,  England,  LE1 5WW,  United Kingdom
United Kingdom, Scotland
      University of Edinburgh, Edinburgh,  Scotland,  EH4 2XU,  United Kingdom

Study chairs or principal investigators

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

Study ID Numbers:  L1069-49
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  December 31, 2002
ClinicalTrials.gov Identifier:  NCT00050973
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08