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

May 13, 2013 updated by: Eisai Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

623

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • Canberra Hospital
    • New South Wales
      • Port Macquarie, New South Wales, Australia, 2444
        • Port Macquarie Base Hospital
      • Wollongong, New South Wales, Australia, 2500
        • Southern Medical Daycare Centre
    • South Australia
      • Toorak Gardens, South Australia, Australia, 5065
        • Burnside War Memorial Hospital
      • Woodville, South Australia, Australia, 5011
        • Queen Elizabeth Hospital
    • Tasmania
      • Hobart, Tasmania, Australia, 7001
        • Royal Hobart Hospital
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Wodonga, Victoria, Australia, 3690
        • Border Medical Oncology
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre
    • Manitoba
      • Winnepeg, Manitoba, Canada, R3E 0V9
        • Cancer Care Manitoba
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • QEII Health Sciences Center
    • Ontario
      • Ottawa, Ontario, Canada, K1H 1C4
        • Ottawa Regional Cancer Centre
  • Czech Republic
      • Ceske Budejovice, Czech Republic, 370 87
        • Nemocnice odd. Onkologie
      • Praha-6-Veleslavin, Czech Republic, CZ-160 00
        • Pneumologicka klinika 1. LF UK
      • Praha-8, Czech Republic, CZ-180 00
        • Klinika pneumologie a hrudni chirurgie 3.LF
  • France
    • Cedex
      • Belfort, Cedex, France, 90016
        • Centre Hospitalier General de Belfort
      • Briey, Cedex, France, 54150
        • Centre Hospitalier Francois Maillot
      • Reims, Cedex, France, 51100
        • Institut Jean Godinot
      • Vesoul, Cedex, France, 70014
        • Centre Hospitalier Intercommunal de la Haute-Saone
  • Greece
      • Athens, Greece, 11527
        • 6th Pneumonology Department, Sotiria Hospital for Diseases of the Chest
      • Athens, Greece, 11527
        • 7th Pneumonology Clinic, Sotiria Hospital for Diseases of the Chest
      • Rio, Greece, 26500
        • University Hospital of Patras
    • Alexandroupolis
      • Dragana, Alexandroupolis, Greece, 68100
        • University Hospital of Alexandroupolis
    • Crete
      • Heraklion, Crete, Greece
        • University General Hospital of Heraklion
    • Thessaloniki
      • Exochi, Thessaloniki, Greece, 57010
        • 1st Pulmonary Clinic of G. Papanikolaou Hospital
      • Exochi, Thessaloniki, Greece, 57010
        • 2nd Pulmonary Clinic of G. Papanikolaou Hospital
  • Hungary
      • Budapest, Hungary, 1125
        • Semmelweis University Department of Pulmonology
      • Budapest, Hungary, 1145
        • Fovarosi Onkormanyzat Uzsoki utcai, Korhaza
      • Budapest, Hungary, 1529
        • Koranyi National Institute for Pulmonology
      • Deszk, Hungary, 6772
        • Csongrad Megyei Onkormanyzat Mellkasi
  • Israel
      • Ashkelon, Israel, 78308
        • Barzilai Medical Centre
      • Jerusalem, Israel, 19200
        • Hadassah Medical Center
      • Kfar Sava, Israel, 44281
        • Meir Hospital
      • Rehovot, Israel, 76100
        • Kaplan Medical Center
      • Tel Aviv, Israel, 64239
        • Tel-Aviv Sovrasky Medical Center
      • Tel Hashomer, Israel, 52620
        • Sheba Medical Center
      • Zerifin, Israel, 70300
        • Assaf Harofeh Medical Center
  • Poland
      • Bialystok, Poland, 15-027
        • Regionalne Centrum Onkologii
      • Gdansk, Poland, 80-216
        • Akademii Medycznej w Gdansku
      • Krakow, Poland, 31-115
        • Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
      • Poznan, Poland, 66-569
        • Wielkopolskie Centrum Chorob Pluc I Gruzlicy
      • Warsaw, Poland, 01-138
        • Instytut Gruzlicy i Chorob Pluc
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163045
        • Arkhangelsk Regional Oncology Center
      • Moscow, Russian Federation, 107005
        • City Oncology Clinical Center
      • Moscow, Russian Federation, 115478
        • Russian Oncology Research Center n.a. Blokhin
      • Moscow, Russian Federation, 12584
        • Research Institute of Oncology n.a. Hertzen
      • Moscow, Russian Federation, 129128
        • Central Clinical Hospital n.a. Semashko
      • Moscow, Russian Federation, 143423
        • City Oncology Hospital #62
      • St. Petersburg, Russian Federation, 197022
        • City Oncology Center
      • St. Petersburg, Russian Federation, 197089
        • St. Petersburg Pavlov State Medical University
      • St. Petersburg, Russian Federation, 197758
        • Research Institute of Oncology n.a. Petrov
  • United Kingdom
    • Aberdeen
      • Foresterhill, Aberdeen, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary
    • England
      • Bristol, England, United Kingdom, BS2 8ED
        • Bristol Hematology and Oncology Centre
      • Leicester, England, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary
      • London, England, United Kingdom, SE1 9RT
        • Guys & St. Thomas' Cancer Centre
      • London, England, United Kingdom, SW10 9NH
        • Chelsea & Westminster Hospital
    • Scotland
      • Edinburgh, Scotland, United Kingdom, EH4 2XU
        • University of Edinburgh
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Brookwood Medical Center
    • Arizona
      • Tucson, Arizona, United States, 85723
        • Southern Arizona VA Healthcare System
    • California
      • Pasadena, California, United States, 91105
        • Arroyo Research Inc.
      • Rancho Mirage, California, United States, 92270
        • Desert Hematology-Oncology Medical Group, Inc.
    • Florida
      • Gainsville, Florida, United States, 32610
        • University of Florida
      • Hudson, Florida, United States, 34667
        • New Hope Cancer Center
      • Miami, Florida, United States, 33125
        • Veterans Affairs Medical Center
      • Palm Harbor, Florida, United States, 34684
        • Bay Area Cancer Consultants
    • Illinois
      • Arlington Heights, Illinois, United States, 60004
        • Northwest Medical Specialists
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Jayne Gurtler, M.D., APMC
      • New Orleans, Louisiana, United States, 70112
        • Louisiana State University Health Science Center
    • Michigan
      • Pontiac, Michigan, United States, 48341
        • St. Joseph Mercy Oakland Hospital
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Capitol Comprehensive Cancer Care Clinic
    • New York
      • Brooklyn, New York, United States, 11203
        • SUNY downstate Medical Center
      • Buffalo, New York, United States, 14215
        • VA Western New York Health Care System
    • Ohio
      • Toledo, Ohio, United States, 43623
        • Hematology-Oncology Associates
    • Oklahoma
      • MIdwest City, Oklahoma, United States, 73110
        • Tariq Mahmood
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • University Oncology & Hematology Associates
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Medical Research Foundation
      • Menomonee Falls, Wisconsin, United States, 53051
        • Medical Associates Health Centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Inc.

Investigators

  • Study Director: Mack Mabry, M.D., Ligand Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

November 1, 2004

Study Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

December 31, 2002

First Submitted That Met QC Criteria

January 2, 2003

First Posted (Estimate)

January 3, 2003

Study Record Updates

Last Update Posted (Estimate)

May 14, 2013

Last Update Submitted That Met QC Criteria

May 13, 2013

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L1069-49

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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