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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

623 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2005-03-31

Brief Summary

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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

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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.

Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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bexarotene

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Inc.

INDUSTRY

Sponsor Role lead

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

Site Status

Southern Arizona VA Healthcare System

Tucson, Arizona, United States

Site Status

Arroyo Research Inc.

Pasadena, California, United States

Site Status

Desert Hematology-Oncology Medical Group, Inc.

Rancho Mirage, California, United States

Site Status

University of Florida

Gainsville, Florida, United States

Site Status

New Hope Cancer Center

Hudson, Florida, United States

Site Status

Veterans Affairs Medical Center

Miami, Florida, United States

Site Status

Bay Area Cancer Consultants

Palm Harbor, Florida, United States

Site Status

Northwest Medical Specialists

Arlington Heights, Illinois, United States

Site Status

Jayne Gurtler, M.D., APMC

Metairie, Louisiana, United States

Site Status

Louisiana State University Health Science Center

New Orleans, Louisiana, United States

Site Status

St. Joseph Mercy Oakland Hospital

Pontiac, Michigan, United States

Site Status

Capitol Comprehensive Cancer Care Clinic

Jefferson City, Missouri, United States

Site Status

SUNY Downstate Medical Center

Brooklyn, New York, United States

Site Status

VA Western New York Health Care System

Buffalo, New York, United States

Site Status

Hematology-Oncology Associates

Toledo, Ohio, United States

Site Status

Tariq Mahmood

Midwest City, Oklahoma, United States

Site Status

University Oncology & Hematology Associates

Chattanooga, Tennessee, United States

Site Status

Marshfield Medical Research Foundation

Marshfield, Wisconsin, United States

Site Status

Medical Associates Health Centers

Menomonee Falls, Wisconsin, United States

Site Status

Canberra Hospital

Garran, Australian Capital Territory, Australia

Site Status

Port Macquarie Base Hospital

Port Macquarie, New South Wales, Australia

Site Status

Southern Medical Daycare Centre

Wollongong, New South Wales, Australia

Site Status

Burnside War Memorial Hospital

Toorak Gardens, South Australia, Australia

Site Status

Queen Elizabeth Hospital

Woodville, South Australia, Australia

Site Status

Royal Hobart Hospital

Hobart, Tasmania, Australia

Site Status

Box Hill Hospital

Box Hill, Victoria, Australia

Site Status

Border Medical Oncology

Wodonga, Victoria, Australia

Site Status

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Site Status

Cancer Care Manitoba

Winnepeg, Manitoba, Canada

Site Status

QEII Health Sciences Center

Halifax, Nova Scotia, Canada

Site Status

Ottawa Regional Cancer Centre

Ottawa, Ontario, Canada

Site Status

Nemocnice odd. Onkologie

České Budějovice, , Czechia

Site Status

Pneumologicka klinika 1. LF UK

Praha-6-Veleslavin, , Czechia

Site Status

Klinika pneumologie a hrudni chirurgie 3.LF

Praha-8, , Czechia

Site Status

Centre Hospitalier General de Belfort

Belfort, Cedex, France

Site Status

Centre Hospitalier Francois Maillot

Briey, Cedex, France

Site Status

Institut Jean Godinot

Reims, Cedex, France

Site Status

Centre Hospitalier Intercommunal de la Haute-Saone

Vesoul, Cedex, France

Site Status

University Hospital of Alexandroupolis

Dragana, Alexandroupolis, Greece

Site Status

University General Hospital of Heraklion

Heraklion, Crete, Greece

Site Status

1st Pulmonary Clinic of G. Papanikolaou Hospital

Exochi, Thessaloniki, Greece

Site Status

2nd Pulmonary Clinic of G. Papanikolaou Hospital

Exochi, Thessaloniki, Greece

Site Status

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

Athens, , Greece

Site Status

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

Athens, , Greece

Site Status

University Hospital of Patras

Rio, , Greece

Site Status

Semmelweis University Department of Pulmonology

Budapest, , Hungary

Site Status

Fovarosi Onkormanyzat Uzsoki utcai, Korhaza

Budapest, , Hungary

Site Status

Koranyi National Institute for Pulmonology

Budapest, , Hungary

Site Status

Csongrad Megyei Onkormanyzat Mellkasi

Deszk, , Hungary

Site Status

Barzilai Medical Centre

Ashkelon, , Israel

Site Status

Hadassah Medical Center

Jerusalem, , Israel

Site Status

Meir Hospital

Kfar Saba, , Israel

Site Status

Kaplan Medical Center

Rehovot, , Israel

Site Status

Tel-Aviv Sovrasky Medical Center

Tel Aviv, , Israel

Site Status

Sheba Medical Center

Tel Litwinsky, , Israel

Site Status

Assaf Harofeh Medical Center

Ẕerifin, , Israel

Site Status

Regionalne Centrum Onkologii

Bialystok, , Poland

Site Status

Akademii Medycznej w Gdansku

Gdansk, , Poland

Site Status

Centrum Onkologii Instytut im. M. Sklodowskiej-Curie

Krakow, , Poland

Site Status

Wielkopolskie Centrum Chorob Pluc I Gruzlicy

Poznan, , Poland

Site Status

Instytut Gruzlicy i Chorob Pluc

Warsaw, , Poland

Site Status

Arkhangelsk Regional Oncology Center

Arkhangelsk, , Russia

Site Status

City Oncology Clinical Center

Moscow, , Russia

Site Status

Russian Oncology Research Center n.a. Blokhin

Moscow, , Russia

Site Status

Research Institute of Oncology n.a. Hertzen

Moscow, , Russia

Site Status

Central Clinical Hospital n.a. Semashko

Moscow, , Russia

Site Status

City Oncology Hospital #62

Moscow, , Russia

Site Status

City Oncology Center

Saint Petersburg, , Russia

Site Status

St. Petersburg Pavlov State Medical University

Saint Petersburg, , Russia

Site Status

Research Institute of Oncology n.a. Petrov

Saint Petersburg, , Russia

Site Status

Aberdeen Royal Infirmary

Foresterhill, Aberdeen, United Kingdom

Site Status

Bristol Hematology and Oncology Centre

Bristol, England, United Kingdom

Site Status

Leicester Royal Infirmary

Leicester, England, United Kingdom

Site Status

Guys & St. Thomas' Cancer Centre

London, England, United Kingdom

Site Status

Chelsea & Westminster Hospital

London, England, United Kingdom

Site Status

University of Edinburgh

Edinburgh, Scotland, United Kingdom

Site Status

Countries

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United States Australia Canada Czechia France Greece Hungary Israel Poland Russia United Kingdom

Related Links

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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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