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

July 7, 2012 updated by: Eisai Inc.

Randomized Phase III Trial Comparing Targretin Capsules/Carboplatin/Paclitaxel Versus Carboplatin/Paclitaxel in Chemotherapy-Naïve 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 Carboplatin and Paclitaxel 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 three 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.
612

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

  • Austria
      • Wels, Austria, 4600
        • Allgemeines offentliches Krankenhaus der barmherzigen Schwestern vom Heiligen Kreuz Pneumologie
      • Wien, Austria, 1145
        • Sozialmedizinisches Zentrum
      • Wien, Austria, A-1100
        • Kaiser-Franz-Josef-Spital
  • Canada
    • Ontario
      • Sault Ste. Marie, Ontario, Canada, P6A 2C4
        • Algoma Regional Cancer Program - Sault Area Hospital
      • Weston, Ontario, Canada, M9N 1N8
        • Humber River Regional Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • S.M.B.D. Jewish General Hospital
  • France
      • Aix en Provence, Cedex 01, France, 13616
        • Centre Hospitalier du Pays d'Aix
      • Annecy Cedex, France, 47011
        • Centre Hospitalier General de la Region Annecienne
      • Antibes Cedex, France, 06606
        • Centre Hospitalier d'Antibes-Juan-Les-Pins
      • Bois Guillaume, France, 76230
        • CHRU Hopital de Bois Guillaume
      • Creteil, France, 94010
        • DOP International
      • Draguignan, France, 83300
        • Hopital de Draguignan
      • Gap Cedex, France, 05007
        • Centre Hospitalier Général
      • Limoges Cedex, France, 87042
        • hôpital du Cluzeau
      • Marseille, Cedex 09, France, 29274
        • CHU Hopital St. Marguerite
      • Montpellier, Cedex 05, France, 34298
        • Centre Regional de Lutte contre le Cancer (CRLC), Val d'Aurelle-Paul Lamarque
      • Paris, Cedex 12, France, 75571
        • Hopital Saint Antoine
      • St. Etienne, Cedex 2, France, 42055
        • Chu - Hopital Nord
      • Toulon Naval, France, 83800
        • Hôpital Saint Anne
      • Vandoeuvre les Nancy, France, 54511
        • Service de Pneumology, Hopital Adulte de Brabois
      • Villefranche sur Soane, France, 69655
        • Centre Hospitalier
  • Germany
      • Andernach, Germany, D-56626
        • Dept. of Internal Medicine, St. Nikolaus-Stiftshospital Andernach
      • Gauting, Germany, D-82131
        • Aesklepios-Fachkliniken Muchen-Gauting
      • GroBhansdorf, Germany, 22927
        • Krankenhaus GroBhansdorf, Zentrum fur Pneumologie und Thoraxchirurgie
      • Munchen, Germany, 80336
        • Ludwig-Maximilians Universitat Munchen
      • SchumannstraBe, Berlin, Germany, 10117
        • Charite Universitatsklinikum der Humboldt-Universitat zu Berlin
  • Spain
      • Castellon, Spain, 12002
        • Hospital Provincial de Castellon
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Valencia, Spain, 46 017
        • Hospital Universitario Doctor Peset
      • Valencia, Spain, 46018
        • Hospital Universitario La Fe Servicio de Oncologia
      • Valencia, Spain, 46039
        • Hospital Arnau de Villanova, Servicio de Oncologia
      • Valencia, Spain, 46044
        • Hospital Clinico Universitario, Servicio Hematologia y Oncologia
      • Valencia, Spain, 46520
        • Hospital de Sagunto Servicio de Oncologia
  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36106
        • Montgomery Cancer Center, L.L.C.
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Arizona Clinical Research Center, Inc.
    • California
      • Concord, California, United States, 94520
        • Bay Area Cancer Research Group, LLC
      • Fountain Valley, California, United States, 92708
        • Pacific Coast Hematology/Oncology Medical Group, Inc.
      • Fountain Valley, California, United States, 92708
        • Compassionate Cancer Care Medical Group, Inc.
      • Greenbrae, California, United States, 94909
        • California Cancer Care, Inc.
      • Long Beach, California, United States, 90806
        • Coast Hematology and Oncology Associates
      • Los Angeles, California, United States, 90057
        • Metropolitan Hematology/Oncology Medical Group
      • Los Angeles, California, United States, 90067
        • Sant P. Chawla, Inc.
      • Los Angeles, California, United States, 94115
        • UCLA Medical Center
      • Modesto, California, United States, 95355
        • Sutter Gould Medical Foundation
      • Orange, California, United States, 92868
        • Medical Oncology Care Associates
      • San Diego, California, United States, 92123
        • SHARP Health Care
      • San Diego, California, United States, 92120
        • Southern California Kaiser Permanente Medical Group
      • San Francisco, California, United States, 94115
        • UCSF/Mount Zion Comprehensive Cancer Center
      • Vista, California, United States, 92083
        • Medical Group of North County, Inc., San Diego Cancer Center
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers - Midtown
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Eastern Connecticut Hematology & Oncology
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Hospital
      • Washington, District of Columbia, United States, 20010
        • Washington Cancer Institute
    • Florida
      • Boca Raton, Florida, United States, 33428
        • Comprehensive Cancer Care Specialists of Boca Raton
      • Jacksonville, Florida, United States, 32209
        • University of Florida/Jacksonville
      • Lakeland, Florida, United States, 33805
        • Watson Clinic
      • Miami, Florida, United States, 33133
        • Oncology and Radiation Associates
      • New Port Richey, Florida, United States, 34652
        • Florida Cancer Institute
      • Orange Park, Florida, United States, 32073
        • Florida Oncology Associates
      • Orlando, Florida, United States, 32806
        • Cancer Centers of Florida, P.A.
      • Plantation, Florida, United States, 33324
        • South Florida Oncology & Hematology Consultants
    • Georgia
      • Augusta, Georgia, United States, 30901
        • Medical Oncology Associates of Augusta
      • Marietta, Georgia, United States, 30060
        • Georgia Oncology Partners Research & Education Foundation
    • Idaho
      • Boise, Idaho, United States, 83712
        • St. Luke's/Mountain State Tumor Institute (MSTI)
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Weiss Memorial Hospital
      • Elk Grove Village, Illinois, United States, 60007
        • Northwest Oncology and Hematology, SC
      • Park Ridge, Illinois, United States, 60068
        • Lutheran General Cancer Care Center
      • Peoria, Illinois, United States, 61602
        • Oncology/Hematology Associates of Central Illinois, P.C.
      • Skokie, Illinois, United States, 60077
        • Hematology Oncology Assoc. of Illinois
    • Indiana
      • Indianapolis, Indiana, United States, 46227
        • Central Indiana Cancer Centers
      • New Albany, Indiana, United States, 47150
        • Cancer Care Center
      • South Bend, Indiana, United States, 46601
        • Michiana Hematology-Oncology
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Kansas City Oncology and Hematology Group, Kansas City Cancer Centers
    • Kentucky
      • Louisville, Kentucky, United States, 40215
        • Drs. Carroll, Sheth, and Raghavan
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • Southwest Oncology Associates
      • Metairie, Louisiana, United States, 70006
        • APMC
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Health Sciences Center
      • New Orleans, Louisiana, United States, 70112
        • Louisiana State University Health Sciences Center
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Mercy Medical Center
      • Baltimore, Maryland, United States, 21225
        • Chesapeake Oncology-Hematology Associates
      • Rockville, Maryland, United States, 20850
        • Associates in Oncology/Hematology PC
    • Massachusetts
      • Pittsfield, Massachusetts, United States, 01201
        • Berkshire Hematology Oncology, PC
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Medical Center
      • Southfield, Michigan, United States, 48075
        • Providence Cancer Institute
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • St. Lukes Hospital
      • Minneapolis, Minnesota, United States, 55407
        • Minnesota Oncology Hematology, P.A.
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Missouri Cancer Associates
    • Montana
      • Billings, Montana, United States, 59101
        • Hematology Oncology Centers of the Northern Rockies
      • Missoula, Montana, United States, 59802
        • Montana Cancer & Infectious Disease Specialists
    • Nevada
      • Henderson, Nevada, United States, 89014
        • Cancer and Blood Specialists of Nevada
      • Las Vegas, Nevada, United States, 89109
        • Nevada Cancer Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • East Orange, New Jersey, United States, 07018
        • VA New Jersey Health Care System
      • East Orange, New Jersey, United States, 07018
        • Orange Medical Group
      • Morristown, New Jersey, United States, 07962
        • Hematology-Oncology Associates of Northern NJ, PA
      • Somerset, New Jersey, United States, 08873
        • Somerset Hematology Oncology Associates
      • Stratford, New Jersey, United States, 08084
        • University of Medicine & Dentistry of NJ, School of Osteopathic Medicine
      • Summit, New Jersey, United States, 07901
        • Overlook Oncology Center
    • New Mexico
      • Farmington, New Mexico, United States, 87401
        • San Juan Oncology Associates
    • New York
      • Albany, New York, United States, 12208
        • New York Oncology Hematology, P.C., Capital District Hematology Oncology Associates
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • Buffalo, New York, United States, 14215
        • Erie Medical Center
      • Great Neck, New York, United States, 11021
        • Arena Oncology Associates
      • Great Neck, New York, United States, 11023
        • Cancer Institute of Long Island, Inc.
      • Great Neck, New York, United States, 11023
        • Cancer Research of Long Island, Inc.
      • Johnson City, New York, United States, 13790
        • Broome Oncology, LLC
      • New York, New York, United States, 10032
        • Columbia Presbyterian Medical Center
      • New York, New York, United States, 10021
        • New York Presbyterian Hospital, Weill Medical College of Cornell University
      • Northport, New York, United States, 11768
        • VA Medical Center
      • Rexford, New York, United States, 12148
        • New York Oncology Hematology, P.C., Riverview Cancer Care Medical Associates
      • Rockville Centre, New York, United States, 11570
        • South Shore Hematology Oncology Associates, PC
    • North Carolina
      • Cary, North Carolina, United States, 27511
        • Raleigh Hematology Oncology Clinic
      • Hickory, North Carolina, United States, 28602
        • Northwest Carolina Oncology and Hematology, P.A.
    • Ohio
      • Canton, Ohio, United States, 44718
        • Nashat Y. Gabrail, MD, Inc.
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati, Barrett Cancer Center
      • Columbus, Ohio, United States, 43206
        • Columbus Community Clinical Oncology Program
      • Dayton, Ohio, United States, 45439
        • Dayton Oncology/Hematology Consultants
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
      • Oklahoma City, Oklahoma, United States, 73120
        • Cancer Care Associates - Mercy Campus
      • Tulsa, Oklahoma, United States, 74136
        • Cancer Care Associates
    • Oregon
      • Portland, Oregon, United States, 97227
        • Oncology/Hematology, Kaiser Permanente Northwest
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Oncology Hematology of Lehigh Valley, PC
      • Kingston, Pennsylvania, United States, 18704
        • Medical Oncology Associates of Wyoming Valley, PC
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Charleston Hematology Oncology P.A.
      • Columbia, South Carolina, United States, 29209
        • WJB Dorn VA Medical Center
      • Columbia, South Carolina, United States, 29203
        • Liberty Hematology/Oncology
      • Seneca, South Carolina, United States, 29672
        • Cancer Centers of the Carolinas
      • Sumter, South Carolina, United States, 29150
        • Santee Hematology/Oncology
    • Tennessee
      • Knoxville, Tennessee, United States, 37916
        • Thompson Cancer Survival Center
      • Memphis, Tennessee, United States, 38104
        • Boston Baskin Cancer Group
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Oncology, P.A.
      • Austin, Texas, United States, 78745
        • South Austin Cancer Center
      • Austin, Texas, United States, 78759
        • Lone Star Oncology Consultants, P.A.
      • Corpus Christi, Texas, United States, 78412
        • Cancer Specialists Of South Texas, Pa
      • Dallas, Texas, United States, 75246
        • Texas Oncology, P.A.
      • Dallas, Texas, United States, 75230
        • Texas Cancer Center at Medical City
      • Fort Worth, Texas, United States, 76104
        • Texas Oncology, P.A.
      • Garland, Texas, United States, 75042
        • Texas Oncology, P.A.
      • Houston, Texas, United States, 77030
        • University of Texas, MD Anderson Cancer Center
      • Midland, Texas, United States, 79701
        • Allison Cancer Center
      • Odessa, Texas, United States, 79761
        • West Texas Cancer Center
      • Richardson, Texas, United States, 75080
        • HOPE Oncology
      • San Antonio, Texas, United States, 78229
        • Hematology & Oncology Associates of South Texas
      • Tyler, Texas, United States, 75702
        • Tyler Cancer Center
      • Wichita Falls, Texas, United States, 76310
        • Texoma Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Utah Cancer Specialists
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Arlington Fairfax Hematology Oncology
      • Charlottesville, Virginia, United States, 22902
        • Hematology Oncology Patient Enterprises, Center for Cancer Care
      • Danville, Virginia, United States, 24541
        • Danville Hematology & Oncology, Inc.
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates
      • Portsmouth, Virginia, United States, 23707
        • Stark MD, PC
      • Richmond, Virginia, United States, 23230
        • Virginia Cancer Institute
    • Washington
      • Yakima, Washington, United States, 98902
        • Yakima Regional Cancer Care Center, Internal Medicine Associates of Yakima, Inc.
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Morgantown Internal Medicine Group

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)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: bexarotene with carboplatin and paclitaxel
Drug: bexarotene with carboplatin and paclitaxel
bexarotene capsules (400 mg/m^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.
Experimental: carboplatin and paclitaxel
Drug: carboplatin and paclitaxel
carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Overall Survival
Time Frame: From date of randomization to date of death
From date of randomization to date of death

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

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2002

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.
July 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.
July 13, 2012

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.
July 7, 2012

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, 2012

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.
  • L1069-48

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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