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Non-small Cell Lung CancerPhase 3NCT00050960

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

A Phase 3 study testing bexarotene with carboplatin and paclitaxel and carboplatin and paclitaxel in people with Non-small Cell Lung Cancer, run by Eisai Inc. at 154 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
bexarotene with carboplatin and paclitaxel and carboplatin and paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
612 participants
Where
154 sitesin 6 countries
Study dates
May 2002to Mar 2005
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

154 sites in 6 countries.

154 sites in 6 countries

United States121 sites

  • New York Oncology Hematology, P.C., Capital District Hematology Oncology Associates

    Albany, New York, 12208

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48109

  • Texas Oncology, P.A.

    Arlington, Texas, 76012

  • Arlington Fairfax Hematology Oncology

    Arlington, Virginia, 22205

  • Medical Oncology Associates of Augusta

    Augusta, Georgia, 30901

  • South Austin Cancer Center

    Austin, Texas, 78745

  • Lone Star Oncology Consultants, P.A.

    Austin, Texas, 78759

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Chesapeake Oncology-Hematology Associates

    Baltimore, Maryland, 21225

  • Oncology Hematology of Lehigh Valley, PC

    Bethlehem, Pennsylvania, 18015

  • Hematology Oncology Centers of the Northern Rockies

    Billings, Montana, 59101

  • Comprehensive Cancer Care Specialists of Boca Raton

    Boca Raton, Florida, 33428

  • St. Luke's/Mountain State Tumor Institute (MSTI)

    Boise, Idaho, 83712

  • Erie Medical Center

    Buffalo, New York, 14215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Nashat Y. Gabrail, MD, Inc.

    Canton, Ohio, 44718

  • Raleigh Hematology Oncology Clinic

    Cary, North Carolina, 27511

  • Charleston Hematology Oncology P.A.

    Charleston, South Carolina, 29403

  • Hematology Oncology Patient Enterprises, Center for Cancer Care

    Charlottesville, Virginia, 22902

  • Weiss Memorial Hospital

    Chicago, Illinois, 60640

  • University of Cincinnati, Barrett Cancer Center

    Cincinnati, Ohio, 45219

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • Liberty Hematology/Oncology

    Columbia, South Carolina, 29203

  • WJB Dorn VA Medical Center

    Columbia, South Carolina, 29209

  • Columbus Community Clinical Oncology Program

    Columbus, Ohio, 43206

  • Bay Area Cancer Research Group, LLC

    Concord, California, 94520

  • Cancer Specialists of South Texas, PA

    Corpus Christi, Texas, 78412

  • Texas Cancer Center at Medical City

    Dallas, Texas, 75230

  • Texas Oncology, P.A.

    Dallas, Texas, 75246

  • Danville Hematology & Oncology, Inc.

    Danville, Virginia, 24541

  • Dayton Oncology/Hematology Consultants

    Dayton, Ohio, 45439

  • Rocky Mountain Cancer Centers - Midtown

    Denver, Colorado, 80218

  • St. Lukes Hospital

    Duluth, Minnesota, 55805

  • Orange Medical Group

    East Orange, New Jersey, 07018

  • VA New Jersey Health Care System

    East Orange, New Jersey, 07018

  • Northwest Oncology and Hematology, SC

    Elk Grove Village, Illinois, 60007

  • San Juan Oncology Associates

    Farmington, New Mexico, 87401

  • Texas Oncology, P.A.

    Fort Worth, Texas, 76104

  • Compassionate Cancer Care Medical Group, Inc.

    Fountain Valley, California, 92708

  • Pacific Coast Hematology/Oncology Medical Group, Inc.

    Fountain Valley, California, 92708

  • Texas Oncology, P.A.

    Garland, Texas, 75042

  • Arena Oncology Associates

    Great Neck, New York, 11021

  • Cancer Institute of Long Island, Inc.

    Great Neck, New York, 11023

  • Cancer Research of Long Island, Inc.

    Great Neck, New York, 11023

  • California Cancer Care, Inc.

    Greenbrae, California, 94909

  • Cancer and Blood Specialists of Nevada

    Henderson, Nevada, 89014

  • Northwest Carolina Oncology and Hematology, P.A.

    Hickory, North Carolina, 28602

  • University of Texas, MD Anderson Cancer Center

    Houston, Texas, 77030

  • Central Indiana Cancer Centers

    Indianapolis, Indiana, 46227

  • University of Florida/Jacksonville

    Jacksonville, Florida, 32209

  • Broome Oncology, LLC

    Johnson City, New York, 13790

  • Medical Oncology Associates of Wyoming Valley, PC

    Kingston, Pennsylvania, 18704

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • Southwest Oncology Associates

    Lafayette, Louisiana, 70503

  • Watson Clinic

    Lakeland, Florida, 33805

  • Nevada Cancer Center

    Las Vegas, Nevada, 89109

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Coast Hematology and Oncology Associates

    Long Beach, California, 90806

  • Metropolitan Hematology/Oncology Medical Group

    Los Angeles, California, 90057

  • Sant P. Chawla, Inc.

    Los Angeles, California, 90067

  • UCLA Medical Center

    Los Angeles, California, 94115

  • Drs. Carroll, Sheth, and Raghavan

    Louisville, Kentucky, 40215

  • Georgia Oncology Partners Research & Education Foundation

    Marietta, Georgia, 30060

  • Boston Baskin Cancer Group

    Memphis, Tennessee, 38104

  • APMC

    Metairie, Louisiana, 70006

  • Oncology and Radiation Associates

    Miami, Florida, 33133

  • Allison Cancer Center

    Midland, Texas, 79701

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota, 55407

  • Montana Cancer & Infectious Disease Specialists

    Missoula, Montana, 59802

  • Sutter Gould Medical Foundation

    Modesto, California, 95355

  • Montgomery Cancer Center, L.L.C.

    Montgomery, Alabama, 36106

  • Morgantown Internal Medicine Group

    Morgantown, West Virginia, 26505

  • Hematology-Oncology Associates of Northern NJ, PA

    Morristown, New Jersey, 07962

  • Cancer Care Center

    New Albany, Indiana, 47150

  • Louisiana State University Health Sciences Center

    New Orleans, Louisiana, 70112

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • Florida Cancer Institute

    New Port Richey, Florida, 34652

  • New York Presbyterian Hospital, Weill Medical College of Cornell University

    New York, New York, 10021

  • Columbia Presbyterian Medical Center

    New York, New York, 10032

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • VA Medical Center

    Northport, New York, 11768

  • Eastern Connecticut Hematology & Oncology

    Norwich, Connecticut, 06360

  • West Texas Cancer Center

    Odessa, Texas, 79761

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Cancer Care Associates - Mercy Campus

    Oklahoma City, Oklahoma, 73120

  • Medical Oncology Care Associates

    Orange, California, 92868

  • Florida Oncology Associates

    Orange Park, Florida, 32073

  • Cancer Centers of Florida, P.A.

    Orlando, Florida, 32806

  • Kansas City Oncology and Hematology Group, Kansas City Cancer Centers

    Overland Park, Kansas, 66210

  • Lutheran General Cancer Care Center

    Park Ridge, Illinois, 60068

  • Oncology/Hematology Associates of Central Illinois, P.C.

    Peoria, Illinois, 61602

  • Berkshire Hematology Oncology, PC

    Pittsfield, Massachusetts, 01201

  • South Florida Oncology & Hematology Consultants

    Plantation, Florida, 33324

  • Oncology/Hematology, Kaiser Permanente Northwest

    Portland, Oregon, 97227

  • Stark MD, PC

    Portsmouth, Virginia, 23707

  • New York Oncology Hematology, P.C., Riverview Cancer Care Medical Associates

    Rexford, New York, 12148

  • Hope Oncology

    Richardson, Texas, 75080

  • Virginia Cancer Institute

    Richmond, Virginia, 23230

  • Associates in Oncology/Hematology PC

    Rockville, Maryland, 20850

  • South Shore Hematology Oncology Associates, PC

    Rockville Centre, New York, 11570

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

  • Hematology & Oncology Associates of South Texas

    San Antonio, Texas, 78229

  • Southern California Kaiser Permanente Medical Group

    San Diego, California, 92120

  • Sharp Health Care

    San Diego, California, 92123

  • UCSF/Mount Zion Comprehensive Cancer Center

    San Francisco, California, 94115

  • Cancer Centers of the Carolinas

    Seneca, South Carolina, 29672

  • Hematology Oncology Assoc. of Illinois

    Skokie, Illinois, 60077

  • Somerset Hematology Oncology Associates

    Somerset, New Jersey, 08873

  • Michiana Hematology-Oncology

    South Bend, Indiana, 46601

  • Providence Cancer Institute

    Southfield, Michigan, 48075

  • University of Medicine & Dentistry of NJ, School of Osteopathic Medicine

    Stratford, New Jersey, 08084

  • Overlook Oncology Center

    Summit, New Jersey, 07901

  • Santee Hematology/Oncology

    Sumter, South Carolina, 29150

  • Arizona Clinical Research Center, Inc.

    Tucson, Arizona, 85712

  • Cancer Care Associates

    Tulsa, Oklahoma, 74136

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • Medical Group of North County, Inc., San Diego Cancer Center

    Vista, California, 92083

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • Washington Cancer Institute

    Washington D.C., District of Columbia, 20010

  • Texoma Cancer Center

    Wichita Falls, Texas, 76310

  • Yakima Regional Cancer Care Center, Internal Medicine Associates of Yakima, Inc.

    Yakima, Washington, 98902

Other trials in United States

France15 sites

  • Centre Hospitalier du Pays d'Aix

    Aix-en-Provence, 13616

  • Centre Hospitalier General de la Region Annecienne

    Annecy, 47011

  • Centre Hospitalier d'Antibes-Juan-Les-Pins

    Antibes, 06606

  • CHRU Hopital de Bois Guillaume

    Bois-Guillaume, 76230

  • DOP International

    Créteil, 94010

  • Hopital de Draguignan

    Draguignan, 83300

  • Centre Hospitalier General

    Gap, 05007

  • Hopital du Cluzeau

    Limoges, 87042

  • CHU Hopital St. Marguerite

    Marseille, 29274

  • Centre Regional de Lutte contre le Cancer (CRLC), Val d'Aurelle-Paul Lamarque

    Montpellier, 34298

  • Hopital Saint Antoine

    Paris, 75571

  • CHU - Hopital Nord

    Saint-Etienne, 42055

  • Hopital Saint Anne

    Toulon Naval, 83800

  • Service de Pneumology, Hopital Adulte de Brabois

    Vandœuvre-lès-Nancy, 54511

  • Centre Hospitalier

    Villefranche Sur Soane, 69655

Other trials in France

Spain7 sites

  • Hospital Provincial de Castellon

    Castellon, 12002

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario Doctor Peset

    Valencia, 46 017

  • Hospital Universitario La Fe Servicio de Oncologia

    Valencia, 46018

  • Hospital Arnau de Villanova, Servicio de Oncologia

    Valencia, 46039

  • Hospital Clinico Universitario, Servicio Hematologia y Oncologia

    Valencia, 46044

  • Hospital de Sagunto Servicio de Oncologia

    Valencia, 46520

Other trials in Spain

Germany5 sites

  • Dept. of Internal Medicine, St. Nikolaus-Stiftshospital Andernach

    Andernach, D-56626

  • Aesklepios-Fachkliniken Muchen-Gauting

    Gauting, D-82131

  • Krankenhaus GroBhansdorf, Zentrum fur Pneumologie und Thoraxchirurgie

    GroBhansdorf, 22927

  • Ludwig-Maximilians Universitat Munchen

    München, 80336

  • Charite Universitatsklinikum der Humboldt-Universitat zu Berlin

    SchumannstraBe, Berlin, 10117

Other trials in Germany

Austria3 sites

  • Sozialmedizinisches Zentrum

    Vienna, 1145

  • Kaiser-Franz-Josef-Spital

    Vienna, A-1100

  • Allgemeines offentliches Krankenhaus der barmherzigen Schwestern vom Heiligen Kreuz Pneumologie

    Wels, 4600

Other trials in Austria

Canada3 sites

  • S.M.B.D. Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Algoma Regional Cancer Program - Sault Area Hospital

    Sault Ste. Marie, Ontario, P6A 2C4

  • Humber River Regional Hospital

    Weston, Ontario, M9N 1N8

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
bexarotene with carboplatin and paclitaxel, carboplatin and paclitaxel
Keywords
NSCLC, Targretin, Retinoid, Bexarotene
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bexarotene with carboplatin and paclitaxelDrug

    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.

  • carboplatin and paclitaxelDrug

    carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks.

Study groups in NCT00050960
Study groupRoleWhat they receive
bexarotene with carboplatin and paclitaxelExperimentalNot described
Receives: Drug: bexarotene with carboplatin and paclitaxel
carboplatin and paclitaxelExperimentalNot described
Receives: Drug: carboplatin and paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Measured: From date of randomization to date of death

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2003 (estimated)
  2. Study startMay 2002
  3. Primary completionJul 2004
  4. Study completionMar 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
612 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00050960
Sponsor's protocol ID
L1069-48
Status last verified
Jul 2012
First submitted
31 Dec 2002
Last updated
13 Jul 2012

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bexarotene with carboplatin and paclitaxel and carboplatin and paclitaxel in people with Non-small Cell Lung Cancer, run by Eisai Inc. at 154 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 154 sites in United States, France, Spain, Germany, Austria and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: From date of randomization to date of death). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00050960.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2012.

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