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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
623

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eisai Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 31, 2002

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2003

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 3, 2003

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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