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

Phase 3
Completed
Conditions
Non-small Cell Lung Cancer
Registration Number
NCT00050973
Lead Sponsor
Eisai Inc.
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
623
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (77)

Guys & St. Thomas' Cancer Centre

🇬🇧

London, England, United Kingdom

Cancer Care Manitoba

🇨🇦

Winnepeg, Manitoba, Canada

University Oncology & Hematology Associates

🇺🇸

Chattanooga, Tennessee, United States

Veterans Affairs Medical Center

🇺🇸

Miami, Florida, United States

Desert Hematology-Oncology Medical Group, Inc.

🇺🇸

Rancho Mirage, California, United States

SUNY Downstate Medical Center

🇺🇸

Brooklyn, New York, United States

Port Macquarie Base Hospital

🇦🇺

Port Macquarie, New South Wales, Australia

Northwest Medical Specialists

🇺🇸

Arlington Heights, Illinois, United States

VA Western New York Health Care System

🇺🇸

Buffalo, New York, United States

Hematology-Oncology Associates

🇺🇸

Toledo, Ohio, United States

Capitol Comprehensive Cancer Care Clinic

🇺🇸

Jefferson City, Missouri, United States

Regionalne Centrum Onkologii

🇵🇱

Bialystok, 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 Center

🇷🇺

St. Petersburg, Russian Federation

Arroyo Research Inc.

🇺🇸

Pasadena, California, United States

University of Florida

🇺🇸

Gainsville, Florida, United States

Jayne Gurtler, M.D., APMC

🇺🇸

Metairie, Louisiana, United States

Tariq Mahmood

🇺🇸

MIdwest City, Oklahoma, United States

Barzilai Medical Centre

🇮🇱

Ashkelon, Israel

Central Clinical Hospital n.a. Semashko

🇷🇺

Moscow, Russian Federation

Brookwood Medical Center

🇺🇸

Birmingham, Alabama, United States

City Oncology Hospital #62

🇷🇺

Moscow, Russian Federation

St. Petersburg Pavlov State Medical University

🇷🇺

St. Petersburg, Russian Federation

Southern Arizona VA Healthcare System

🇺🇸

Tucson, Arizona, United States

Southern Medical Daycare Centre

🇦🇺

Wollongong, New South Wales, Australia

Research Institute of Oncology n.a. Petrov

🇷🇺

St. Petersburg, Russian Federation

Bristol Hematology and Oncology Centre

🇬🇧

Bristol, England, United Kingdom

Chelsea & Westminster Hospital

🇬🇧

London, England, United Kingdom

Marshfield Medical Research Foundation

🇺🇸

Marshfield, Wisconsin, United States

Pneumologicka klinika 1. LF UK

🇨🇿

Praha-6-Veleslavin, Czech Republic

2nd Pulmonary Clinic of G. Papanikolaou Hospital

🇬🇷

Exochi, Thessaloniki, Greece

Hadassah Medical Center

🇮🇱

Jerusalem, Israel

Assaf Harofeh Medical Center

🇮🇱

Zerifin, Israel

Burnside War Memorial Hospital

🇦🇺

Toorak Gardens, South Australia, Australia

Box Hill Hospital

🇦🇺

Box Hill, Victoria, Australia

Klinika pneumologie a hrudni chirurgie 3.LF

🇨🇿

Praha-8, Czech Republic

Institut Jean Godinot

🇫🇷

Reims, Cedex, France

University Hospital of Alexandroupolis

🇬🇷

Dragana, Alexandroupolis, Greece

Meir Hospital

🇮🇱

Kfar Sava, Israel

Kaplan Medical Center

🇮🇱

Rehovot, Israel

St. Joseph Mercy Oakland Hospital

🇺🇸

Pontiac, Michigan, United States

Queen Elizabeth Hospital

🇦🇺

Woodville, South Australia, Australia

Fovarosi Onkormanyzat Uzsoki utcai, Korhaza

🇭🇺

Budapest, Hungary

Koranyi National Institute for Pulmonology

🇭🇺

Budapest, Hungary

Centre Hospitalier General de Belfort

🇫🇷

Belfort, Cedex, France

Centre Hospitalier Francois Maillot

🇫🇷

Briey, Cedex, France

University General Hospital of Heraklion

🇬🇷

Heraklion, Crete, Greece

1st Pulmonary Clinic of G. Papanikolaou Hospital

🇬🇷

Exochi, Thessaloniki, Greece

6th Pneumonology Department, Sotiria Hospital for Diseases of the Chest

🇬🇷

Athens, Greece

University Hospital of Patras

🇬🇷

Rio, Greece

Research Institute of Oncology n.a. Hertzen

🇷🇺

Moscow, Russian Federation

7th Pneumonology Clinic, Sotiria Hospital for Diseases of the Chest

🇬🇷

Athens, Greece

Csongrad Megyei Onkormanyzat Mellkasi

🇭🇺

Deszk, Hungary

Akademii Medycznej w Gdansku

🇵🇱

Gdansk, Poland

QEII Health Sciences Center

🇨🇦

Halifax, Nova Scotia, Canada

Louisiana State University Health Science Center

🇺🇸

New Orleans, Louisiana, United States

New Hope Cancer Center

🇺🇸

Hudson, Florida, United States

Bay Area Cancer Consultants

🇺🇸

Palm Harbor, Florida, United States

Medical Associates Health Centers

🇺🇸

Menomonee Falls, Wisconsin, United States

Canberra Hospital

🇦🇺

Garran, Australian Capital Territory, Australia

Royal Hobart Hospital

🇦🇺

Hobart, Tasmania, Australia

Semmelweis University Department of Pulmonology

🇭🇺

Budapest, Hungary

Ottawa Regional Cancer Centre

🇨🇦

Ottawa, Ontario, Canada

Nemocnice odd. Onkologie

🇨🇿

Ceske Budejovice, Czech Republic

Centre Hospitalier Intercommunal de la Haute-Saone

🇫🇷

Vesoul, Cedex, France

Tel-Aviv Sovrasky Medical Center

🇮🇱

Tel Aviv, Israel

Centrum Onkologii Instytut im. M. Sklodowskiej-Curie

🇵🇱

Krakow, Poland

Border Medical Oncology

🇦🇺

Wodonga, Victoria, Australia

City Oncology Clinical Center

🇷🇺

Moscow, Russian Federation

Russian Oncology Research Center n.a. Blokhin

🇷🇺

Moscow, Russian Federation

Leicester Royal Infirmary

🇬🇧

Leicester, England, United Kingdom

Sheba Medical Center

🇮🇱

Tel Hashomer, Israel

Aberdeen Royal Infirmary

🇬🇧

Foresterhill, Aberdeen, United Kingdom

Tom Baker Cancer Centre

🇨🇦

Calgary, Alberta, Canada

University of Edinburgh

🇬🇧

Edinburgh, Scotland, United Kingdom

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