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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
Not Enrolling
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

- 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:


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:


Principal Investigator

Mack Mabry, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Ligand Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

May 2002

Completion Date:

March 2005

Related Keywords:

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



Roswell Park Cancer Institute Buffalo, New York  14263
Lutheran General Cancer Care Center Park Ridge, Illinois  60068
Texas Oncology, P.A. Dallas, Texas  75246
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104
Thompson Cancer Survival Center Knoxville, Tennessee  37916
California Cancer Care, Inc. Greenbrae, California  94904-2007
Virginia Oncology Associates Newport News, Virginia  23606
Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756
Oncology/Hematology Associates of Central Illinois, P.C. Peoria, Illinois  61602
Cancer Centers of the Carolinas Greenville, South Carolina  29605
Nevada Cancer Center Las Vegas, Nevada  89109
Missouri Cancer Associates Columbia, Missouri  65201
Cancer Care Associates - Mercy Campus Oklahoma City, Oklahoma  73120
Washington Cancer Institute Washington, District of Columbia  20010
Cancer Care Center New Albany, Indiana  47150
Arena Oncology Associates Great Neck, New York  11021
Watson Clinic Lakeland, Florida  33805
Sutter Gould Medical Foundation Modesto, California  95353
Comprehensive Cancer Care Specialists of Boca Raton Boca Raton, Florida  33428
Florida Oncology Associates Orange Park, Florida  32073
Tyler Cancer Center Tyler, Texas  75702
Boston Baskin Cancer Group Memphis, Tennessee  38104
Morgantown Internal Medicine Group Morgantown, West Virginia  26505
University of Michigan Medical Center Ann Arbor, Michigan  48104-0914
Berkshire Hematology Oncology, PC Pittsfield, Massachusetts  01201
Medical Oncology Care Associates Orange, California  92668
Cancer Care Associates Tulsa, Oklahoma  74136
Rocky Mountain Cancer Centers - Midtown Denver, Colorado  80218
UCLA Medical Center Los Angeles, California  90095-7059
Louisiana State University Health Sciences Center Shreveport, Louisiana  71130
Columbia Presbyterian Medical Center New York, New York  10032
Weiss Memorial Hospital Chicago,, Illinois  60640
WJB Dorn VA Medical Center Columbia, South Carolina  29209
Liberty Hematology/Oncology Columbia, South Carolina  
Cancer Centers of Florida, P.A. Orlando, Florida  
Raleigh Hematology Oncology Clinic Cary, North Carolina  27511
Virginia Cancer Institute Richmond, Virginia  23230
Arizona Clinical Research Center, Inc. Tucson, Arizona  85712
Utah Cancer Specialists Salt 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, LLC Concord, California  94520
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Sant P. Chawla, Inc. Los Angeles, California  90067
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Medical Group of North County, Inc., San Diego Cancer Center Vista, California  92083
Eastern Connecticut Hematology & Oncology Norwich, Connecticut  06360
Georgetown University Hospital Washington, District of Columbia  20007
University of Florida/Jacksonville Jacksonville, Florida  32209
Oncology and Radiation Associates Miami, Florida  33133
Florida Cancer Institute New Port Richey, Florida  34652
South Florida Oncology & Hematology Consultants Plantation, Florida  33324
Medical Oncology Associates of Augusta Augusta, Georgia  30901
Georgia Oncology Partners Research & Education Foundation Marietta, Georgia  30060
St. Luke's/Mountain State Tumor Institute (MSTI) Boise, Idaho  83712
Northwest Oncology and Hematology, SC Elk Grove Village, Illinois  60007
Hematology Oncology Assoc. of Illinois Skokie, Illinois  60077
Central Indiana Cancer Centers Indianapolis, Indiana  46227
Michiana Hematology-Oncology South Bend, Indiana  46601
Kansas City Oncology and Hematology Group, Kansas City Cancer Centers Overland Park, Kansas  66210
Drs. Carroll, Sheth, and Raghavan Louisville, Kentucky  40215
Southwest Oncology Associates Lafayette, Louisiana  70503
APMC Metairie, Louisiana  70006
Tulane University Health Sciences Center New Orleans, Louisiana  70112
Mercy Medical Center Baltimore, Maryland  21202
Chesapeake Oncology-Hematology Associates Baltimore, Maryland  21225
Associates in Oncology/Hematology PC Rockville, Maryland  20850
Providence Cancer Institute Southfield, Michigan  48075
St. Lukes Hospital Duluth, Minnesota  55805
Minnesota Oncology Hematology, P.A. Minneapolis, Minnesota  55407
Hematology Oncology Centers of the Northern Rockies Billings, Montana  59101
Montana Cancer & Infectious Disease Specialists Missoula, Montana  59802
Cancer and Blood Specialists of Nevada Henderson, Nevada  89014
Orange Medical Group East Orange, New Jersey  07018
VA New Jersey Health Care System East Orange, New Jersey  07018
Hematology-Oncology Associates of Northern NJ, PA Morristown, New Jersey  07962
Somerset Hematology Oncology Associates Somerset, New Jersey  08873
University of Medicine & Dentistry of NJ, School of Osteopathic Medicine Stratford, New Jersey  08084
Overlook Oncology Center Summit, New Jersey  07901
San Juan Oncology Associates Farmington, New Mexico  87401
New York Oncology Hematology, P.C., Capital District Hematology Oncology Associates Albany, New York  12208
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Cancer Research of Long Island, Inc. Great Neck, New York  11023
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Northwest Carolina Oncology and Hematology, P.A. Hickory, North Carolina  28602
Nashat Y. Gabrail, MD, Inc. Canton, Ohio  44718
University of Cincinnati, Barrett Cancer Center Cincinnati, Ohio  45219
Columbus Community Clinical Oncology Program Columbus, Ohio  43206
Dayton Oncology/Hematology Consultants Dayton, Ohio  45439
Oncology/Hematology, Kaiser Permanente Northwest Portland, Oregon  97227
Oncology Hematology of Lehigh Valley, PC Bethlehem, Pennsylvania  18015
Medical Oncology Associates of Wyoming Valley, PC Kingston, Pennsylvania  18704
Charleston Hematology Oncology P.A. Charleston, South Carolina  29403
Santee Hematology/Oncology Sumter, South Carolina  29150
Lone Star Oncology Consultants, P.A. Austin, Texas  78759
South Austin Cancer Center Austin, Texas  78745
Cancer Specialists of South Texas, PA Corpus Christi, Texas  78412
Texas Cancer Center at Medical City Dallas, Texas  75230
University of Texas, MD Anderson Cancer Center Houston, Texas  77030
Allison Cancer Center Midland, Texas  79701
West Texas Cancer Center Odessa, Texas  79761
Hope Oncology Richardson, Texas  75080
Hematology & Oncology Associates of South Texas San Antonio, Texas  78229
Texoma Cancer Center Wichita Falls, Texas  76310
Arlington Fairfax Hematology Oncology Arlington, Virginia  22205
Hematology Oncology Patient Enterprises, Center for Cancer Care Charlottesville, Virginia  22902
Danville Hematology & Oncology, Inc. Danville, Virginia  24541
Stark MD, PC Portsmouth, Virginia  23707
Yakima Regional Cancer Care Center, Internal Medicine Associates of Yakima, Inc. Yakima, Washington  98902