Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer
NCT ID: NCT00050973
Last Updated: 2013-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
623 participants
INTERVENTIONAL
2005-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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bexarotene
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Principal Investigators
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Mack Mabry, M.D.
Role: STUDY_DIRECTOR
Ligand Pharmaceuticals
Locations
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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
České Budějovice, , Czechia
Pneumologicka klinika 1. LF UK
Praha-6-Veleslavin, , Czechia
Klinika pneumologie a hrudni chirurgie 3.LF
Praha-8, , Czechia
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 Saba, , Israel
Kaplan Medical Center
Rehovot, , Israel
Tel-Aviv Sovrasky Medical Center
Tel Aviv, , Israel
Sheba Medical Center
Tel Litwinsky, , Israel
Assaf Harofeh Medical Center
Ẕerifin, , 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, , Russia
City Oncology Clinical Center
Moscow, , Russia
Russian Oncology Research Center n.a. Blokhin
Moscow, , Russia
Research Institute of Oncology n.a. Hertzen
Moscow, , Russia
Central Clinical Hospital n.a. Semashko
Moscow, , Russia
City Oncology Hospital #62
Moscow, , Russia
City Oncology Center
Saint Petersburg, , Russia
St. Petersburg Pavlov State Medical University
Saint Petersburg, , Russia
Research Institute of Oncology n.a. Petrov
Saint Petersburg, , Russia
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
Countries
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Related Links
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Related Info
Other Identifiers
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L1069-49
Identifier Type: -
Identifier Source: org_study_id
NCT00030927
Identifier Type: -
Identifier Source: nct_alias
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