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Brief Title: Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer
Official Title: Randomized Phase III Trial Comparing Targretin Capsules/Cisplatin/Vinorelbine Versus Cisplatin/Vinorelbine in Chemotherapy-Naive Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
Study ID: NCT00050973
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 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. 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.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Brookwood Medical Center, Birmingham, Alabama, United States
Southern Arizona VA Healthcare System, Tucson, Arizona, United States
Arroyo Research Inc., Pasadena, California, United States
Desert Hematology-Oncology Medical Group, Inc., Rancho Mirage, California, United States
University of Florida, Gainsville, Florida, United States
New Hope Cancer Center, Hudson, Florida, United States
Veterans Affairs Medical Center, Miami, Florida, United States
Bay Area Cancer Consultants, Palm Harbor, Florida, United States
Northwest Medical Specialists, Arlington Heights, Illinois, United States
Jayne Gurtler, M.D., APMC, Metairie, Louisiana, United States
Louisiana State University Health Science Center, New Orleans, Louisiana, United States
St. Joseph Mercy Oakland Hospital, Pontiac, Michigan, United States
Capitol Comprehensive Cancer Care Clinic, Jefferson City, Missouri, United States
SUNY Downstate Medical Center, Brooklyn, New York, United States
VA Western New York Health Care System, Buffalo, New York, United States
Hematology-Oncology Associates, Toledo, Ohio, United States
Tariq Mahmood, MIdwest City, Oklahoma, United States
University Oncology & Hematology Associates, Chattanooga, Tennessee, United States
Marshfield Medical Research Foundation, Marshfield, Wisconsin, United States
Medical Associates Health Centers, Menomonee Falls, Wisconsin, United States
Canberra Hospital, Garran, Australian Capital Territory, Australia
Port Macquarie Base Hospital, Port Macquarie, New South Wales, Australia
Southern Medical Daycare Centre, Wollongong, New South Wales, Australia
Burnside War Memorial Hospital, Toorak Gardens, South Australia, Australia
Queen Elizabeth Hospital, Woodville, South Australia, Australia
Royal Hobart Hospital, Hobart, Tasmania, Australia
Box Hill Hospital, Box Hill, Victoria, Australia
Border Medical Oncology, Wodonga, Victoria, Australia
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Cancer Care Manitoba, Winnepeg, Manitoba, Canada
QEII Health Sciences Center, Halifax, Nova Scotia, Canada
Ottawa Regional Cancer Centre, Ottawa, Ontario, Canada
Nemocnice odd. Onkologie, Ceske Budejovice, , Czech Republic
Pneumologicka klinika 1. LF UK, Praha-6-Veleslavin, , Czech Republic
Klinika pneumologie a hrudni chirurgie 3.LF, Praha-8, , Czech Republic
Centre Hospitalier General de Belfort, Belfort, Cedex, France
Centre Hospitalier Francois Maillot, Briey, Cedex, France
Institut Jean Godinot, Reims, Cedex, France
Centre Hospitalier Intercommunal de la Haute-Saone, Vesoul, Cedex, France
University Hospital of Alexandroupolis, Dragana, Alexandroupolis, Greece
University General Hospital of Heraklion, Heraklion, Crete, Greece
1st Pulmonary Clinic of G. Papanikolaou Hospital, Exochi, Thessaloniki, Greece
2nd Pulmonary Clinic of G. Papanikolaou Hospital, Exochi, Thessaloniki, Greece
6th Pneumonology Department, Sotiria Hospital for Diseases of the Chest, Athens, , Greece
7th Pneumonology Clinic, Sotiria Hospital for Diseases of the Chest, Athens, , Greece
University Hospital of Patras, Rio, , Greece
Semmelweis University Department of Pulmonology, Budapest, , Hungary
Fovarosi Onkormanyzat Uzsoki utcai, Korhaza, Budapest, , Hungary
Koranyi National Institute for Pulmonology, Budapest, , Hungary
Csongrad Megyei Onkormanyzat Mellkasi, Deszk, , Hungary
Barzilai Medical Centre, Ashkelon, , Israel
Hadassah Medical Center, Jerusalem, , Israel
Meir Hospital, Kfar Sava, , Israel
Kaplan Medical Center, Rehovot, , Israel
Tel-Aviv Sovrasky Medical Center, Tel Aviv, , Israel
Sheba Medical Center, Tel Hashomer, , Israel
Assaf Harofeh Medical Center, Zerifin, , Israel
Regionalne Centrum Onkologii, Bialystok, , Poland
Akademii Medycznej w Gdansku, Gdansk, , Poland
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Krakow, , Poland
Wielkopolskie Centrum Chorob Pluc I Gruzlicy, Poznan, , Poland
Instytut Gruzlicy i Chorob Pluc, Warsaw, , Poland
Arkhangelsk Regional Oncology Center, Arkhangelsk, , Russian Federation
City Oncology Clinical Center, Moscow, , Russian Federation
Russian Oncology Research Center n.a. Blokhin, Moscow, , Russian Federation
Research Institute of Oncology n.a. Hertzen, Moscow, , Russian Federation
Central Clinical Hospital n.a. Semashko, Moscow, , Russian Federation
City Oncology Hospital #62, Moscow, , Russian Federation
City Oncology Center, St. Petersburg, , Russian Federation
St. Petersburg Pavlov State Medical University, St. Petersburg, , Russian Federation
Research Institute of Oncology n.a. Petrov, St. Petersburg, , Russian Federation
Aberdeen Royal Infirmary, Foresterhill, Aberdeen, United Kingdom
Bristol Hematology and Oncology Centre, Bristol, England, United Kingdom
Leicester Royal Infirmary, Leicester, England, United Kingdom
Guys & St. Thomas' Cancer Centre, London, England, United Kingdom
Chelsea & Westminster Hospital, London, England, United Kingdom
University of Edinburgh, Edinburgh, Scotland, United Kingdom
Name: Mack Mabry, M.D.
Affiliation: Ligand Pharmaceuticals
Role: STUDY_DIRECTOR