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

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Trial Identification

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

Interventions

bexarotene

Study Description

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.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Mack Mabry, M.D.

Affiliation: Ligand Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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