Clinical trial NCT00050960: Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer
Keywords: NSCLC
Targretin
Retinoid
Bexarotene
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2003-01-03
Enrollment: 612
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival
timeFrame: From date of randomization to date of death
Secondary outcomes:
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Montgomery Cancer Center, L.L.C.
state: Alabama
city: Tucson
country: United States
facility: Arizona Clinical Research Center, Inc.
state: Arizona
city: Concord
country: United States
facility: Bay Area Cancer Research Group, LLC
state: California
city: Fountain Valley
country: United States
facility: Compassionate Cancer Care Medical Group, Inc.
state: California
city: Fountain Valley
country: United States
facility: Pacific Coast Hematology/Oncology Medical Group, Inc.
state: California
city: Greenbrae
country: United States
facility: California Cancer Care, Inc.
state: California
city: Long Beach
country: United States
facility: Coast Hematology and Oncology Associates
state: California
city: Los Angeles
country: United States
facility: Metropolitan Hematology/Oncology Medical Group
state: California
city: Los Angeles
country: United States
facility: Sant P. Chawla, Inc.
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Modesto
country: United States
facility: Sutter Gould Medical Foundation
state: California
city: Orange
country: United States
facility: Medical Oncology Care Associates
state: California
city: San Diego
country: United States
facility: Southern California Kaiser Permanente Medical Group
state: California
city: San Diego
country: United States
facility: Sharp Health Care
state: California
city: San Francisco
country: United States
facility: UCSF/Mount Zion Comprehensive Cancer Center
state: California
city: Vista
country: United States
facility: Medical Group of North County, Inc., San Diego Cancer Center
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers - Midtown
state: Colorado
city: Norwich
country: United States
facility: Eastern Connecticut Hematology & Oncology
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Washington
country: United States
facility: Washington Cancer Institute
state: District of Columbia
city: Boca Raton
country: United States
facility: Comprehensive Cancer Care Specialists of Boca Raton
state: Florida
city: Jacksonville
country: United States
facility: University of Florida/Jacksonville
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic
state: Florida
city: Miami
country: United States
facility: Oncology and Radiation Associates
state: Florida
city: New Port Richey
country: United States
facility: Florida Cancer Institute
state: Florida
city: Orange Park
country: United States
facility: Florida Oncology Associates
state: Florida
city: Orlando
country: United States
facility: Cancer Centers of Florida, P.A.
state: Florida
city: Plantation
country: United States
facility: South Florida Oncology & Hematology Consultants
state: Florida
city: Augusta
country: United States
facility: Medical Oncology Associates of Augusta
state: Georgia
city: Marietta
country: United States
facility: Georgia Oncology Partners Research & Education Foundation
state: Georgia
city: Boise
country: United States
facility: St. Luke's/Mountain State Tumor Institute (MSTI)
state: Idaho
city: Chicago
country: United States
facility: Weiss Memorial Hospital
state: Illinois
city: Elk Grove Village
country: United States
facility: Northwest Oncology and Hematology, SC
state: Illinois
city: Park Ridge
country: United States
facility: Lutheran General Cancer Care Center
state: Illinois
city: Peoria
country: United States
facility: Oncology/Hematology Associates of Central Illinois, P.C.
state: Illinois
city: Skokie
country: United States
facility: Hematology Oncology Assoc. of Illinois
state: Illinois
city: Indianapolis
country: United States
facility: Central Indiana Cancer Centers
state: Indiana
city: New Albany
country: United States
facility: Cancer Care Center
state: Indiana
city: South Bend
country: United States
facility: Michiana Hematology-Oncology
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Oncology and Hematology Group, Kansas City Cancer Centers
state: Kansas
city: Louisville
country: United States
facility: Drs. Carroll, Sheth, and Raghavan
state: Kentucky
city: Lafayette
country: United States
facility: Southwest Oncology Associates
state: Louisiana
city: Metairie
country: United States
facility: APMC
state: Louisiana
city: New Orleans
country: United States
facility: Louisiana State University Health Sciences Center
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Chesapeake Oncology-Hematology Associates
state: Maryland
city: Rockville
country: United States
facility: Associates in Oncology/Hematology PC
state: Maryland
city: Pittsfield
country: United States
facility: Berkshire Hematology Oncology, PC
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: Southfield
country: United States
facility: Providence Cancer Institute
state: Michigan
city: Duluth
country: United States
facility: St. Lukes Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Columbia
country: United States
facility: Missouri Cancer Associates
state: Missouri
city: Billings
country: United States
facility: Hematology Oncology Centers of the Northern Rockies
state: Montana
city: Missoula
country: United States
facility: Montana Cancer & Infectious Disease Specialists
state: Montana
city: Henderson
country: United States
facility: Cancer and Blood Specialists of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Nevada Cancer Center
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: East Orange
country: United States
facility: Orange Medical Group
state: New Jersey
city: East Orange
country: United States
facility: VA New Jersey Health Care System
state: New Jersey
city: Morristown
country: United States
facility: Hematology-Oncology Associates of Northern NJ, PA
state: New Jersey
city: Somerset
country: United States
facility: Somerset Hematology Oncology Associates
state: New Jersey
city: Stratford
country: United States
facility: University of Medicine & Dentistry of NJ, School of Osteopathic Medicine
state: New Jersey
city: Summit
country: United States
facility: Overlook Oncology Center
state: New Jersey
city: Farmington
country: United States
facility: San Juan Oncology Associates
state: New Mexico
city: Albany
country: United States
facility: New York Oncology Hematology, P.C., Capital District Hematology Oncology Associates
state: New York
city: Buffalo
country: United States
facility: Erie Medical Center
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Great Neck
country: United States
facility: Arena Oncology Associates
state: New York
city: Great Neck
country: United States
facility: Cancer Institute of Long Island, Inc.
state: New York
city: Great Neck
country: United States
facility: Cancer Research of Long Island, Inc.
state: New York
city: Johnson City
country: United States
facility: Broome Oncology, LLC
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital, Weill Medical College of Cornell University
state: New York
city: New York
country: United States
facility: Columbia Presbyterian Medical Center
state: New York
city: Northport
country: United States
facility: VA Medical Center
state: New York
city: Rexford
country: United States
facility: New York Oncology Hematology, P.C., Riverview Cancer Care Medical Associates
state: New York
city: Rockville Centre
country: United States
facility: South Shore Hematology Oncology Associates, PC
state: New York
city: Cary
country: United States
facility: Raleigh Hematology Oncology Clinic
state: North Carolina
city: Hickory
country: United States
facility: Northwest Carolina Oncology and Hematology, P.A.
state: North Carolina
city: Canton
country: United States
facility: Nashat Y. Gabrail, MD, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati, Barrett Cancer Center
state: Ohio
city: Columbus
country: United States
facility: Columbus Community Clinical Oncology Program
state: Ohio
city: Dayton
country: United States
facility: Dayton Oncology/Hematology Consultants
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Cancer Care Associates - Mercy Campus
state: Oklahoma
city: Tulsa
country: United States
facility: Cancer Care Associates
state: Oklahoma
city: Portland
country: United States
facility: Oncology/Hematology, Kaiser Permanente Northwest
state: Oregon
city: Bethlehem
country: United States
facility: Oncology Hematology of Lehigh Valley, PC
state: Pennsylvania
city: Kingston
country: United States
facility: Medical Oncology Associates of Wyoming Valley, PC
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Hematology Oncology P.A.
state: South Carolina
city: Columbia
country: United States
facility: Liberty Hematology/Oncology
state: South Carolina
city: Columbia
country: United States
facility: WJB Dorn VA Medical Center
state: South Carolina
city: Seneca
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Sumter
country: United States
facility: Santee Hematology/Oncology
state: South Carolina
city: Knoxville
country: United States
facility: Thompson Cancer Survival Center
state: Tennessee
city: Memphis
country: United States
facility: Boston Baskin Cancer Group
state: Tennessee
city: Arlington
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Austin
country: United States
facility: South Austin Cancer Center
state: Texas
city: Austin
country: United States
facility: Lone Star Oncology Consultants, P.A.
state: Texas
city: Corpus Christi
country: United States
facility: Cancer Specialists of South Texas, PA
state: Texas
city: Dallas
country: United States
facility: Texas Cancer Center at Medical City
state: Texas
city: Dallas
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Garland
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Houston
country: United States
facility: University of Texas, MD Anderson Cancer Center
state: Texas
city: Midland
country: United States
facility: Allison Cancer Center
state: Texas
city: Odessa
country: United States
facility: West Texas Cancer Center
state: Texas
city: Richardson
country: United States
facility: Hope Oncology
state: Texas
city: San Antonio
country: United States
facility: Hematology & Oncology Associates of South Texas
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Wichita Falls
country: United States
facility: Texoma Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Arlington
country: United States
facility: Arlington Fairfax Hematology Oncology
state: Virginia
city: Charlottesville
country: United States
facility: Hematology Oncology Patient Enterprises, Center for Cancer Care
state: Virginia
city: Danville
country: United States
facility: Danville Hematology & Oncology, Inc.
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Portsmouth
country: United States
facility: Stark MD, PC
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Yakima
country: United States
facility: Yakima Regional Cancer Care Center, Internal Medicine Associates of Yakima, Inc.
state: Washington
city: Morgantown
country: United States
facility: Morgantown Internal Medicine Group
state: West Virginia
city: Wels
country: Austria
facility: Allgemeines offentliches Krankenhaus der barmherzigen Schwestern vom Heiligen Kreuz Pneumologie
city: Wien
country: Austria
facility: Sozialmedizinisches Zentrum
city: Wien
country: Austria
facility: Kaiser-Franz-Josef-Spital
city: Sault Ste. Marie
country: Canada
facility: Algoma Regional Cancer Program - Sault Area Hospital
state: Ontario
city: Weston
country: Canada
facility: Humber River Regional Hospital
state: Ontario
city: Montreal
country: Canada
facility: S.M.B.D. Jewish General Hospital
state: Quebec
city: Aix en Provence, Cedex 01
country: France
facility: Centre Hospitalier du Pays d'Aix
city: Annecy Cedex
country: France
facility: Centre Hospitalier General de la Region Annecienne
city: Antibes Cedex
country: France
facility: Centre Hospitalier d'Antibes-Juan-Les-Pins
city: Bois Guillaume
country: France
facility: CHRU Hopital de Bois Guillaume
city: Creteil
country: France
facility: DOP International
city: Draguignan
country: France
facility: Hopital de Draguignan
city: Gap Cedex
country: France
facility: Centre Hospitalier General
city: Limoges Cedex
country: France
facility: Hopital du Cluzeau
city: Marseille, Cedex 09
country: France
facility: CHU Hopital St. Marguerite
city: Montpellier, Cedex 05
country: France
facility: Centre Regional de Lutte contre le Cancer (CRLC), Val d'Aurelle-Paul Lamarque
city: Paris, Cedex 12
country: France
facility: Hopital Saint Antoine
city: St. Etienne, Cedex 2
country: France
facility: CHU - Hopital Nord
city: Toulon Naval
country: France
facility: Hopital Saint Anne
city: Vandoeuvre les Nancy
country: France
facility: Service de Pneumology, Hopital Adulte de Brabois
city: Villefranche sur Soane
country: France
facility: Centre Hospitalier
city: Andernach
country: Germany
facility: Dept. of Internal Medicine, St. Nikolaus-Stiftshospital Andernach
city: Gauting
country: Germany
facility: Aesklepios-Fachkliniken Muchen-Gauting
city: GroBhansdorf
country: Germany
facility: Krankenhaus GroBhansdorf, Zentrum fur Pneumologie und Thoraxchirurgie
city: Munchen
country: Germany
facility: Ludwig-Maximilians Universitat Munchen
city: SchumannstraBe, Berlin
country: Germany
facility: Charite Universitatsklinikum der Humboldt-Universitat zu Berlin
city: Castellon
country: Spain
facility: Hospital Provincial de Castellon
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset
city: Valencia
country: Spain
facility: Hospital Universitario La Fe Servicio de Oncologia
city: Valencia
country: Spain
facility: Hospital Arnau de Villanova, Servicio de Oncologia
city: Valencia
country: Spain
facility: Hospital Clinico Universitario, Servicio Hematologia y Oncologia
city: Valencia
country: Spain
facility: Hospital de Sagunto Servicio de Oncologia
Study officials:
affiliation: Ligand Pharmaceuticals
name: Mack Mabry, M.D.
role: STUDY_DIRECTOR
References: