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

NCT00050960 | Completed Phase 3 Results

• 1 other identifier: L1069-48
• Study Type: interventional
• Target: 612
• Locations: 6 countries
• Sites: 154

Brief 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.

Conditions

Non-small Cell Lung Cancer

Keywords

NSCLC; Targretin; Retinoid; Bexarotene

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  From date of randomization to date of death

Study Arms (2)

bexarotene with carboplatin and paclitaxel

EXPERIMENTAL

Drug: bexarotene with carboplatin and paclitaxel

carboplatin and paclitaxel

EXPERIMENTAL

Drug: carboplatin and paclitaxel

Interventions

bexarotene with carboplatin and paclitaxel DRUG

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.

bexarotene with carboplatin and paclitaxel

carboplatin and paclitaxel DRUG

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

carboplatin and paclitaxel

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (154)

Montgomery Cancer Center, L.L.C.

Montgomery, Alabama, 36106, United States

Location

Arizona Clinical Research Center, Inc.

Tucson, Arizona, 85712, United States

Location

Bay Area Cancer Research Group, LLC

Concord, California, 94520, United States

Location

Compassionate Cancer Care Medical Group, Inc.

Fountain Valley, California, 92708, United States

Location

Pacific Coast Hematology/Oncology Medical Group, Inc.

Fountain Valley, California, 92708, United States

Location

California Cancer Care, Inc.

Greenbrae, California, 94909, United States

Location

Coast Hematology and Oncology Associates

Long Beach, California, 90806, United States

Location

Metropolitan Hematology/Oncology Medical Group

Los Angeles, California, 90057, United States

Location

Sant P. Chawla, Inc.

Los Angeles, California, 90067, United States

Location

UCLA Medical Center

Los Angeles, California, 94115, United States

Location

Sutter Gould Medical Foundation

Modesto, California, 95355, United States

Location

Medical Oncology Care Associates

Orange, California, 92868, United States

Location

Southern California Kaiser Permanente Medical Group

San Diego, California, 92120, United States

Location

Sharp Health Care

San Diego, California, 92123, United States

Location

UCSF/Mount Zion Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

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

Vista, California, 92083, United States

Location

Rocky Mountain Cancer Centers - Midtown

Denver, Colorado, 80218, United States

Location

Eastern Connecticut Hematology & Oncology

Norwich, Connecticut, 06360, United States

Location

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Washington Cancer Institute

Washington D.C., District of Columbia, 20010, United States

Location

Comprehensive Cancer Care Specialists of Boca Raton

Boca Raton, Florida, 33428, United States

Location

University of Florida/Jacksonville

Jacksonville, Florida, 32209, United States

Location

Watson Clinic

Lakeland, Florida, 33805, United States

Location

Oncology and Radiation Associates

Miami, Florida, 33133, United States

Location

Florida Cancer Institute

New Port Richey, Florida, 34652, United States

Location

Florida Oncology Associates

Orange Park, Florida, 32073, United States

Location

Cancer Centers of Florida, P.A.

Orlando, Florida, 32806, United States

Location

South Florida Oncology & Hematology Consultants

Plantation, Florida, 33324, United States

Location

Medical Oncology Associates of Augusta

Augusta, Georgia, 30901, United States

Location

Georgia Oncology Partners Research & Education Foundation

Marietta, Georgia, 30060, United States

Location

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

Boise, Idaho, 83712, United States

Location

Weiss Memorial Hospital

Chicago, Illinois, 60640, United States

Location

Northwest Oncology and Hematology, SC

Elk Grove Village, Illinois, 60007, United States

Location

Lutheran General Cancer Care Center

Park Ridge, Illinois, 60068, United States

Location

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

Peoria, Illinois, 61602, United States

Location

Hematology Oncology Assoc. of Illinois

Skokie, Illinois, 60077, United States

Location

Central Indiana Cancer Centers

Indianapolis, Indiana, 46227, United States

Location

Cancer Care Center

New Albany, Indiana, 47150, United States

Location

Michiana Hematology-Oncology

South Bend, Indiana, 46601, United States

Location

Kansas City Oncology and Hematology Group, Kansas City Cancer Centers

Overland Park, Kansas, 66210, United States

Location

Drs. Carroll, Sheth, and Raghavan

Louisville, Kentucky, 40215, United States

Location

Southwest Oncology Associates

Lafayette, Louisiana, 70503, United States

Location

APMC

Metairie, Louisiana, 70006, United States

Location

Louisiana State University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Tulane University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

Chesapeake Oncology-Hematology Associates

Baltimore, Maryland, 21225, United States

Location

Associates in Oncology/Hematology PC

Rockville, Maryland, 20850, United States

Location

Berkshire Hematology Oncology, PC

Pittsfield, Massachusetts, 01201, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

Providence Cancer Institute

Southfield, Michigan, 48075, United States

Location

St. Lukes Hospital

Duluth, Minnesota, 55805, United States

Location

Minnesota Oncology Hematology, P.A.

Minneapolis, Minnesota, 55407, United States

Location

Missouri Cancer Associates

Columbia, Missouri, 65201, United States

Location

Hematology Oncology Centers of the Northern Rockies

Billings, Montana, 59101, United States

Location

Montana Cancer & Infectious Disease Specialists

Missoula, Montana, 59802, United States

Location

Cancer and Blood Specialists of Nevada

Henderson, Nevada, 89014, United States

Location

Nevada Cancer Center

Las Vegas, Nevada, 89109, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Orange Medical Group

East Orange, New Jersey, 07018, United States

Location

VA New Jersey Health Care System

East Orange, New Jersey, 07018, United States

Location

Hematology-Oncology Associates of Northern NJ, PA

Morristown, New Jersey, 07962, United States

Location

Somerset Hematology Oncology Associates

Somerset, New Jersey, 08873, United States

Location

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

Stratford, New Jersey, 08084, United States

Location

Overlook Oncology Center

Summit, New Jersey, 07901, United States

Location

San Juan Oncology Associates

Farmington, New Mexico, 87401, United States

Location

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

Albany, New York, 12208, United States

Location

Erie Medical Center

Buffalo, New York, 14215, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Arena Oncology Associates

Great Neck, New York, 11021, United States

Location

Cancer Institute of Long Island, Inc.

Great Neck, New York, 11023, United States

Location

Cancer Research of Long Island, Inc.

Great Neck, New York, 11023, United States

Location

Broome Oncology, LLC

Johnson City, New York, 13790, United States

Location

New York Presbyterian Hospital, Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Columbia Presbyterian Medical Center

New York, New York, 10032, United States

Location

VA Medical Center

Northport, New York, 11768, United States

Location

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

Rexford, New York, 12148, United States

Location

South Shore Hematology Oncology Associates, PC

Rockville Centre, New York, 11570, United States

Location

Raleigh Hematology Oncology Clinic

Cary, North Carolina, 27511, United States

Location

Northwest Carolina Oncology and Hematology, P.A.

Hickory, North Carolina, 28602, United States

Location

Nashat Y. Gabrail, MD, Inc.

Canton, Ohio, 44718, United States

Location

University of Cincinnati, Barrett Cancer Center

Cincinnati, Ohio, 45219, United States

Location

Columbus Community Clinical Oncology Program

Columbus, Ohio, 43206, United States

Location

Dayton Oncology/Hematology Consultants

Dayton, Ohio, 45439, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Cancer Care Associates - Mercy Campus

Oklahoma City, Oklahoma, 73120, United States

Location

Cancer Care Associates

Tulsa, Oklahoma, 74136, United States

Location

Oncology/Hematology, Kaiser Permanente Northwest

Portland, Oregon, 97227, United States

Location

Oncology Hematology of Lehigh Valley, PC

Bethlehem, Pennsylvania, 18015, United States

Location

Medical Oncology Associates of Wyoming Valley, PC

Kingston, Pennsylvania, 18704, United States

Location

Charleston Hematology Oncology P.A.

Charleston, South Carolina, 29403, United States

Location

Liberty Hematology/Oncology

Columbia, South Carolina, 29203, United States

Location

WJB Dorn VA Medical Center

Columbia, South Carolina, 29209, United States

Location

Cancer Centers of the Carolinas

Seneca, South Carolina, 29672, United States

Location

Santee Hematology/Oncology

Sumter, South Carolina, 29150, United States

Location

Thompson Cancer Survival Center

Knoxville, Tennessee, 37916, United States

Location

Boston Baskin Cancer Group

Memphis, Tennessee, 38104, United States

Location

Texas Oncology, P.A.

Arlington, Texas, 76012, United States

Location

South Austin Cancer Center

Austin, Texas, 78745, United States

Location

Lone Star Oncology Consultants, P.A.

Austin, Texas, 78759, United States

Location

Cancer Specialists of South Texas, PA

Corpus Christi, Texas, 78412, United States

Location

Texas Cancer Center at Medical City

Dallas, Texas, 75230, United States

Location

Texas Oncology, P.A.

Dallas, Texas, 75246, United States

Location

Texas Oncology, P.A.

Fort Worth, Texas, 76104, United States

Location

Texas Oncology, P.A.

Garland, Texas, 75042, United States

Location

University of Texas, MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Allison Cancer Center

Midland, Texas, 79701, United States

Location

West Texas Cancer Center

Odessa, Texas, 79761, United States

Location

Hope Oncology

Richardson, Texas, 75080, United States

Location

Hematology & Oncology Associates of South Texas

San Antonio, Texas, 78229, United States

Location

Tyler Cancer Center

Tyler, Texas, 75702, United States

Location

Texoma Cancer Center

Wichita Falls, Texas, 76310, United States

Location

Utah Cancer Specialists

Salt Lake City, Utah, 84106, United States

Location

Arlington Fairfax Hematology Oncology

Arlington, Virginia, 22205, United States

Location

Hematology Oncology Patient Enterprises, Center for Cancer Care

Charlottesville, Virginia, 22902, United States

Location

Danville Hematology & Oncology, Inc.

Danville, Virginia, 24541, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Stark MD, PC

Portsmouth, Virginia, 23707, United States

Location

Virginia Cancer Institute

Richmond, Virginia, 23230, United States

Location

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

Yakima, Washington, 98902, United States

Location

Morgantown Internal Medicine Group

Morgantown, West Virginia, 26505, United States

Location

Sozialmedizinisches Zentrum

Vienna, 1145, Austria

Location

Kaiser-Franz-Josef-Spital

Vienna, A-1100, Austria

Location

Allgemeines offentliches Krankenhaus der barmherzigen Schwestern vom Heiligen Kreuz Pneumologie

Wels, 4600, Austria

Location

Algoma Regional Cancer Program - Sault Area Hospital

Sault Ste. Marie, Ontario, P6A 2C4, Canada

Location

Humber River Regional Hospital

Weston, Ontario, M9N 1N8, Canada

Location

S.M.B.D. Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Centre Hospitalier du Pays d'Aix

Aix-en-Provence, 13616, France

Location

Centre Hospitalier General de la Region Annecienne

Annecy, 47011, France

Location

Centre Hospitalier d'Antibes-Juan-Les-Pins

Antibes, 06606, France

Location

CHRU Hopital de Bois Guillaume

Bois-Guillaume, 76230, France

Location

DOP International

Créteil, 94010, France

Location

Hopital de Draguignan

Draguignan, 83300, France

Location

Centre Hospitalier General

Gap, 05007, France

Location

Hopital du Cluzeau

Limoges, 87042, France

Location

CHU Hopital St. Marguerite

Marseille, 29274, France

Location

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

Montpellier, 34298, France

Location

Hopital Saint Antoine

Paris, 75571, France

Location

CHU - Hopital Nord

Saint-Etienne, 42055, France

Location

Hopital Saint Anne

Toulon Naval, 83800, France

Location

Service de Pneumology, Hopital Adulte de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Centre Hospitalier

Villefranche Sur Soane, 69655, France

Location

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

Andernach, D-56626, Germany

Location

Aesklepios-Fachkliniken Muchen-Gauting

Gauting, D-82131, Germany

Location

Krankenhaus GroBhansdorf, Zentrum fur Pneumologie und Thoraxchirurgie

GroBhansdorf, 22927, Germany

Location

Ludwig-Maximilians Universitat Munchen

München, 80336, Germany

Location

Charite Universitatsklinikum der Humboldt-Universitat zu Berlin

SchumannstraBe, Berlin, 10117, Germany

Location

Hospital Provincial de Castellon

Castellon, 12002, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario Doctor Peset

Valencia, 46 017, Spain

Location

Hospital Universitario La Fe Servicio de Oncologia

Valencia, 46018, Spain

Location

Hospital Arnau de Villanova, Servicio de Oncologia

Valencia, 46039, Spain

Location

Hospital Clinico Universitario, Servicio Hematologia y Oncologia

Valencia, 46044, Spain

Location

Hospital de Sagunto Servicio de Oncologia

Valencia, 46520, Spain

Location

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Bexarotene; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Coordination Complexes; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Results Point of Contact

• Title: Eisai, Inc.
• Organization: Eisai Call Center

888-422-4743

Study Officials

• Mack Mabry, M.D.

  Ligand Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 31, 2002
• First Posted: January 3, 2003
• Study Start: May 1, 2002
• Primary Completion: July 1, 2004
• Study Completion: March 1, 2005
• Last Updated: July 13, 2012
• Results First Posted: August 24, 2010

Record last verified: 2012-07

Locations

US (121); DE (5); ES (7); FR (15); CA (3); AU (3)