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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


Phase 3
N/A
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer

Thank you

Trial Information

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
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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

From date of randomization to date of death

Safety Issue:

No

Principal Investigator

Mack Mabry, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Ligand Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

L1069-48

NCT ID:

NCT00050960

Start Date:

May 2002

Completion Date:

March 2005

Related Keywords:

  • Non-Small Cell Lung Cancer
  • NSCLC
  • Targretin
  • Retinoid
  • Bexarotene
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Lutheran General Cancer Care CenterPark Ridge, Illinois  60068
Texas Oncology, P.A.Dallas, Texas  75246
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Thompson Cancer Survival CenterKnoxville, Tennessee  37916
California Cancer Care, Inc.Greenbrae, California  94904-2007
Virginia Oncology AssociatesNewport News, Virginia  23606
Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756
Oncology/Hematology Associates of Central Illinois, P.C.Peoria, Illinois  61602
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Nevada Cancer CenterLas Vegas, Nevada  89109
Missouri Cancer AssociatesColumbia, Missouri  65201
Cancer Care Associates - Mercy CampusOklahoma City, Oklahoma  73120
Washington Cancer InstituteWashington, District of Columbia  20010
Cancer Care CenterNew Albany, Indiana  47150
Arena Oncology AssociatesGreat Neck, New York  11021
Watson ClinicLakeland, Florida  33805
Sutter Gould Medical FoundationModesto, California  95353
Comprehensive Cancer Care Specialists of Boca RatonBoca Raton, Florida  33428
Florida Oncology AssociatesOrange Park, Florida  32073
Tyler Cancer CenterTyler, Texas  75702
Boston Baskin Cancer GroupMemphis, Tennessee  38104
Morgantown Internal Medicine GroupMorgantown, West Virginia  26505
University of Michigan Medical CenterAnn Arbor, Michigan  48104-0914
Berkshire Hematology Oncology, PCPittsfield, Massachusetts  01201
Medical Oncology Care AssociatesOrange, California  92668
Cancer Care AssociatesTulsa, Oklahoma  74136
Rocky Mountain Cancer Centers - MidtownDenver, Colorado  80218
UCLA Medical CenterLos Angeles, California  90095-7059
Louisiana State University Health Sciences CenterShreveport, Louisiana  71130
Columbia Presbyterian Medical CenterNew York, New York  10032
Weiss Memorial HospitalChicago,, Illinois  60640
WJB Dorn VA Medical CenterColumbia, South Carolina  29209
Liberty Hematology/OncologyColumbia, South Carolina  
Cancer Centers of Florida, P.A.Orlando, Florida  
Raleigh Hematology Oncology ClinicCary, North Carolina  27511
Virginia Cancer InstituteRichmond, Virginia  23230
Arizona Clinical Research Center, Inc.Tucson, Arizona  85712
Utah Cancer SpecialistsSalt Lake City, Utah  84106
Compassionate Cancer Care medical Group, Inc.Fountain Valley, California  92708
Montgomery Cancer Center, L.L.C.Montgomery, Alabama  36106
Bay Area Cancer Research Group, LLCConcord, California  94520
Pacific Coast Hematology/Oncology Medical Group, Inc.Fountain Valley, California  92708
Coast Hematology and Oncology AssociatesLong Beach, California  90806
Sant P. Chawla, Inc.Los Angeles, California  90067
Metropolitan Hematology/Oncology Medical GroupLos Angeles, California  90057
Sharp Health CareSan Diego, California  92123
Southern California Kaiser Permanente Medical GroupSan Diego, California  92120
UCSF/Mount Zion Comprehensive Cancer CenterSan Francisco, California  94115
Medical Group of North County, Inc., San Diego Cancer CenterVista, California  92083
Eastern Connecticut Hematology & OncologyNorwich, Connecticut  06360
Georgetown University HospitalWashington, District of Columbia  20007
University of Florida/JacksonvilleJacksonville, Florida  32209
Oncology and Radiation AssociatesMiami, Florida  33133
Florida Cancer InstituteNew Port Richey, Florida  34652
South Florida Oncology & Hematology ConsultantsPlantation, Florida  33324
Medical Oncology Associates of AugustaAugusta, Georgia  30901
Georgia Oncology Partners Research & Education FoundationMarietta, Georgia  30060
St. Luke's/Mountain State Tumor Institute (MSTI)Boise, Idaho  83712
Northwest Oncology and Hematology, SCElk Grove Village, Illinois  60007
Hematology Oncology Assoc. of IllinoisSkokie, Illinois  60077
Central Indiana Cancer CentersIndianapolis, Indiana  46227
Michiana Hematology-OncologySouth Bend, Indiana  46601
Kansas City Oncology and Hematology Group, Kansas City Cancer CentersOverland Park, Kansas  66210
Drs. Carroll, Sheth, and RaghavanLouisville, Kentucky  40215
Southwest Oncology AssociatesLafayette, Louisiana  70503
APMCMetairie, Louisiana  70006
Tulane University Health Sciences CenterNew Orleans, Louisiana  70112
Mercy Medical CenterBaltimore, Maryland  21202
Chesapeake Oncology-Hematology AssociatesBaltimore, Maryland  21225
Associates in Oncology/Hematology PCRockville, Maryland  20850
Providence Cancer InstituteSouthfield, Michigan  48075
St. Lukes HospitalDuluth, Minnesota  55805
Minnesota Oncology Hematology, P.A.Minneapolis, Minnesota  55407
Hematology Oncology Centers of the Northern RockiesBillings, Montana  59101
Montana Cancer & Infectious Disease SpecialistsMissoula, Montana  59802
Cancer and Blood Specialists of NevadaHenderson, Nevada  89014
Orange Medical GroupEast Orange, New Jersey  07018
VA New Jersey Health Care SystemEast Orange, New Jersey  07018
Hematology-Oncology Associates of Northern NJ, PAMorristown, New Jersey  07962
Somerset Hematology Oncology AssociatesSomerset, New Jersey  08873
University of Medicine & Dentistry of NJ, School of Osteopathic MedicineStratford, New Jersey  08084
Overlook Oncology CenterSummit, New Jersey  07901
San Juan Oncology AssociatesFarmington, New Mexico  87401
New York Oncology Hematology, P.C., Capital District Hematology Oncology AssociatesAlbany, New York  12208
Erie Medical CenterBuffalo, New York  14215
Cancer Research of Long Island, Inc.Great Neck, New York  11023
Cancer Institute of Long Island, Inc.Great Neck, New York  11023
Broome Oncology, LLCJohnson City, New York  13790
New York Presbyterian Hospital, Weill Medical College of Cornell UniversityNew York, New York  10021
VA Medical CenterNorthport, New York  11768
New York Oncology Hematology, P.C., Riverview Cancer Care Medical AssociatesRexford, New York  12148
South Shore Hematology Oncology Associates, PCRockville Centre, New York  11570
Northwest Carolina Oncology and Hematology, P.A.Hickory, North Carolina  28602
Nashat Y. Gabrail, MD, Inc.Canton, Ohio  44718
University of Cincinnati, Barrett Cancer CenterCincinnati, Ohio  45219
Columbus Community Clinical Oncology ProgramColumbus, Ohio  43206
Dayton Oncology/Hematology ConsultantsDayton, Ohio  45439
Oncology/Hematology, Kaiser Permanente NorthwestPortland, Oregon  97227
Oncology Hematology of Lehigh Valley, PCBethlehem, Pennsylvania  18015
Medical Oncology Associates of Wyoming Valley, PCKingston, Pennsylvania  18704
Charleston Hematology Oncology P.A.Charleston, South Carolina  29403
Santee Hematology/OncologySumter, South Carolina  29150
Lone Star Oncology Consultants, P.A.Austin, Texas  78759
South Austin Cancer CenterAustin, Texas  78745
Cancer Specialists of South Texas, PACorpus Christi, Texas  78412
Texas Cancer Center at Medical CityDallas, Texas  75230
University of Texas, MD Anderson Cancer CenterHouston, Texas  77030
Allison Cancer CenterMidland, Texas  79701
West Texas Cancer CenterOdessa, Texas  79761
Hope OncologyRichardson, Texas  75080
Hematology & Oncology Associates of South TexasSan Antonio, Texas  78229
Texoma Cancer CenterWichita Falls, Texas  76310
Arlington Fairfax Hematology OncologyArlington, Virginia  22205
Hematology Oncology Patient Enterprises, Center for Cancer CareCharlottesville, Virginia  22902
Danville Hematology & Oncology, Inc.Danville, Virginia  24541
Stark MD, PCPortsmouth, Virginia  23707
Yakima Regional Cancer Care Center, Internal Medicine Associates of Yakima, Inc.Yakima, Washington  98902