Randomized Phase III Trial Comparing Targretin Capsules/Cisplatin/Vinorelbine Versus Cisplatin/Vinorelbine in Chemotherapy-Naive Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
This study evaluates the use of Targretin capsules (bexarotene) in combination with
Cisplatin and Vinorelbine 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 four 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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Mack Mabry, M.D.
Study Director
Ligand Pharmaceuticals
United States: Food and Drug Administration
L1069-49
NCT00050973
March 2005
Name | Location |
---|---|
Capitol Comprehensive Cancer Care Clinic | Jefferson City, Missouri 65109 |
SUNY Downstate Medical Center | Brooklyn, New York 11203 |
University of Florida | Gainesville, Florida 32610-0277 |
Brookwood Medical Center | Birmingham, Alabama 35209-6804 |
St. Joseph Mercy Oakland Hospital | Pontiac, Michigan 33308 |
Northwest Medical Specialists | Arlington Heights, Illinois 60004 |
Southern Arizona VA Healthcare System | Tucson, Arizona 85723 |
Arroyo Research Inc. | Pasadena, California 91105 |
Desert Hematology-Oncology Medical Group, Inc. | Rancho Mirage, California 92270 |
New Hope Cancer Center | Hudson, Florida 34667 |
Veterans Affairs Medical Center | Miami, Florida 33125 |
Bay Area Cancer Consultants | Palm Harbor, Florida 34684 |
Jayne Gurtler, M.D., APMC | Metairie, Louisiana 70006 |
Louisiana State University Health Science Center | New Orleans, Louisiana 70112 |
VA Western New York Health Care System | Buffalo, New York 14215 |
Hematology-Oncology Associates | Toledo, Ohio 43623 |
Tariq Mahmood | MIdwest City, Oklahoma 73110 |
University Oncology & Hematology Associates | Chattanooga, Tennessee 37404 |
Marshfield Medical Research Foundation | Marshfield, Wisconsin 54449 |
Medical Associates Health Centers | Menomonee Falls, Wisconsin 53051 |