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
N/A
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer
Both
Non-small Cell Lung Cancer
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 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 |
| Pacific Coast Hematology/Oncology Medical Group, Inc. | Fountain Valley, California 92708 |
| Coast Hematology and Oncology Associates | Long Beach, California 90806 |
| Sant P. Chawla, Inc. | Los Angeles, California 90067 |
| Metropolitan Hematology/Oncology Medical Group | Los Angeles, California 90057 |
| Sharp Health Care | San Diego, California 92123 |
| Southern California Kaiser Permanente Medical Group | San Diego, California 92120 |
| UCSF/Mount Zion Comprehensive Cancer Center | San Francisco, California 94115 |
| 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 |
| Erie Medical Center | Buffalo, 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, LLC | Johnson City, New York 13790 |
| New York Presbyterian Hospital, Weill Medical College of Cornell University | New York, New York 10021 |
| VA Medical Center | Northport, New York 11768 |
| New York Oncology Hematology, P.C., Riverview Cancer Care Medical Associates | Rexford, New York 12148 |
| South Shore Hematology Oncology Associates, PC | Rockville 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 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 |
