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| Sponsor: | Eisai Inc. |
|---|---|
| Information provided by: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT00050960 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small Cell Lung Cancer |
Drug: Targretin capsules |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Enrollment: | 612 |
| Study Completion Date: | March 2005 |
| Primary Completion Date: | July 2004 (Final data collection date for primary outcome measure) |
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Patients must have:
Patients must be able to complete at least four cycles of combination chemotherapy (i.e., approximately four months)
Patients must not have had:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Montgomery Cancer Center, L.L.C. | |
| Montgomery, Alabama, United States, 36106 | |
| United States, Arizona | |
| Arizona Clinical Research Center, Inc. | |
| Tucson, Arizona, United States, 85712 | |
| United States, California | |
| Sutter Gould Medical Foundation | |
| Modesto, California, United States, 95355 | |
| Sharp Health Care | |
| San Diego, California, United States, 92123 | |
| Metropolitan Hematology/Oncology Medical Group | |
| Los Angeles, California, United States, 90057 | |
| California Cancer Care, Inc. | |
| Greenbrae, California, United States, 94909 | |
| Compassionate Cancer Care Medical Group, Inc. | |
| Fountain Valley, California, United States, 92708 | |
| Pacific Coast Hematology/Oncology Medical Group, Inc. | |
| Fountain Valley, California, United States, 92708 | |
| Sant P. Chawla, Inc. | |
| LOS ANGELES, California, United States, 90067 | |
| Southern California Kaiser Permanente Medical Group | |
| San Diego, California, United States, 92120 | |
| Medical Group of North County, Inc., San Diego Cancer Center | |
| Vista, California, United States, 92083 | |
| Medical Oncology Care Associates | |
| Orange, California, United States, 92868 | |
| Bay Area Cancer Research Group, LLC | |
| Concord, California, United States, 94520 | |
| UCSF/Mount Zion Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| Coast Hematology and Oncology Associates | |
| Long Beach, California, United States, 90806 | |
| UCLA Medical Center | |
| Los Angeles, California, United States, 94115 | |
| United States, Colorado | |
| Rocky Mountain Cancer Centers - Midtown | |
| Denver, Colorado, United States, 80218 | |
| United States, Connecticut | |
| Eastern Connecticut Hematology & Oncology | |
| Norwich, Connecticut, United States, 06360 | |
| United States, District of Columbia | |
| Georgetown University Hospital | |
| Washington, District of Columbia, United States, 20007 | |
| Washington Cancer Institute | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Oncology and Radiation Associates | |
| Miami, Florida, United States, 33133 | |
| University of Florida/Jacksonville | |
| Jacksonville, Florida, United States, 32209 | |
| Florida Oncology Associates | |
| Orange Park, Florida, United States, 32073 | |
| Florida Cancer Institute | |
| New Port Richey, Florida, United States, 34652 | |
| Comprehensive Cancer Care Specialists of Boca Raton | |
| Boca Raton, Florida, United States, 33428 | |
| Watson Clinic | |
| Lakeland, Florida, United States, 33805 | |
| Cancer Centers of Florida, P.A. | |
| Orlando, Florida, United States, 32806 | |
| South Florida Oncology & Hematology Consultants | |
| Plantation, Florida, United States, 33324 | |
| United States, Georgia | |
| Medical Oncology Associates of Augusta | |
| Augusta, Georgia, United States, 30901 | |
| Georgia Oncology Partners Research & Education Foundation | |
| Marietta, Georgia, United States, 30060 | |
| United States, Idaho | |
| St. Luke's/Mountain State Tumor Institute (MSTI) | |
| Boise, Idaho, United States, 83712 | |
| United States, Illinois | |
| Lutheran General Cancer Care Center | |
| Park Ridge, Illinois, United States, 60068 | |
| Northwest Oncology and Hematology, SC | |
| Elk Grove Village, Illinois, United States, 60007 | |
| Oncology/Hematology Associates of Central Illinois, P.C. | |
| Peoria, Illinois, United States, 61602 | |
| Hematology Oncology Assoc. of Illinois | |
| Skokie, Illinois, United States, 60077 | |
| Weiss Memorial Hospital | |
| Chicago, Illinois, United States, 60640 | |
| United States, Indiana | |
| Cancer Care Center | |
| New Albany, Indiana, United States, 47150 | |
| Michiana Hematology-Oncology | |
| South Bend, Indiana, United States, 46601 | |
| Central Indiana Cancer Centers | |
| Indianapolis, Indiana, United States, 46227 | |
| United States, Kansas | |
| Kansas City Oncology and Hematology Group, Kansas City Cancer Centers | |
| Overland Park, Kansas, United States, 66210 | |
| United States, Kentucky | |
| Drs. Carroll, Sheth, and Raghavan | |
| Louisville, Kentucky, United States, 40215 | |
| United States, Louisiana | |
| APMC | |
| Metairie, Louisiana, United States, 70006 | |
| Southwest Oncology Associates | |
| Lafayette, Louisiana, United States, 70503 | |
| Louisiana State University Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| Tulane University Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Chesapeake Oncology-Hematology Associates | |
| Baltimore, Maryland, United States, 21225 | |
| Mercy Medical Center | |
| Baltimore, Maryland, United States, 21202 | |
| Associates in Oncology/Hematology PC | |
| Rockville, Maryland, United States, 20850 | |
| United States, Massachusetts | |
| Berkshire Hematology Oncology, PC | |
| Pittsfield, Massachusetts, United States, 01201 | |
| United States, Michigan | |
| Providence Cancer Institute | |
| Southfield, Michigan, United States, 48075 | |
| University of Michigan Medical Center | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Minnesota | |
| St. Lukes Hospital | |
| Duluth, Minnesota, United States, 55805 | |
| Minnesota Oncology Hematology, P.A. | |
| Minneapolis, Minnesota, United States, 55407 | |
| United States, Missouri | |
| Missouri Cancer Associates | |
| Columbia, Missouri, United States, 65201 | |
| United States, Montana | |
| Montana Cancer & Infectious Disease Specialists | |
| Missoula, Montana, United States, 59802 | |
| Hematology Oncology Centers of the Northern Rockies | |
| Billings, Montana, United States, 59101 | |
| United States, Nevada | |
| Cancer and Blood Specialists of Nevada | |
| Henderson, Nevada, United States, 89014 | |
| Nevada Cancer Center | |
| Las Vegas, Nevada, United States, 89109 | |
| United States, New Hampshire | |
| Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New Jersey | |
| Orange Medical Group | |
| East Orange, New Jersey, United States, 07018 | |
| VA New Jersey Health Care System | |
| East Orange, New Jersey, United States, 07018 | |
| Somerset Hematology Oncology Associates | |
| Somerset, New Jersey, United States, 08873 | |
| University of Medicine & Dentistry of NJ, School of Osteopathic Medicine | |
| Stratford, New Jersey, United States, 08084 | |
| Overlook Oncology Center | |
| Summit, New Jersey, United States, 07901 | |
| Hematology-Oncology Associates of Northern NJ, PA | |
| Morristown, New Jersey, United States, 07962 | |
| United States, New Mexico | |
| San Juan Oncology Associates | |
| Farmington, New Mexico, United States, 87401 | |
| United States, New York | |
| Arena Oncology Associates | |
| Great Neck, New York, United States, 11021 | |
| Erie Medical Center | |
| Buffalo, New York, United States, 14215 | |
| VA Medical Center | |
| Northport, New York, United States, 11768 | |
| Columbia Presbyterian Medical Center | |
| New York, New York, United States, 10032 | |
| New York Presbyterian Hospital, Weill Medical College of Cornell University | |
| New York, New York, United States, 10021 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263 | |
| Cancer Research of Long Island, Inc. | |
| Great Neck, New York, United States, 11023 | |
| New York Oncology Hematology, P.C., Riverview Cancer Care Medical Associates | |
| Rexford, New York, United States, 12148 | |
| Cancer Institute of Long Island, Inc. | |
| Great Neck, New York, United States, 11023 | |
| Broome Oncology, LLC | |
| Johnson City, New York, United States, 13790 | |
| New York Oncology Hematology, P.C., Capital District Hematology Oncology Associates | |
| Albany, New York, United States, 12208 | |
| South Shore Hematology Oncology Associates, PC | |
| Rockville Centre, New York, United States, 11570 | |
| United States, North Carolina | |
| Northwest Carolina Oncology and Hematology, P.A. | |
| Hickory, North Carolina, United States, 28602 | |
| Raleigh Hematology Oncology Clinic | |
| Cary, North Carolina, United States, 27511 | |
| United States, Ohio | |
| Nashat Y. Gabrail, MD, Inc. | |
| Canton, Ohio, United States, 44718 | |
| Dayton Oncology/Hematology Consultants | |
| Dayton, Ohio, United States, 45439 | |
| Columbus Community Clinical Oncology Program | |
| Columbus, Ohio, United States, 43206 | |
| University of Cincinnati, Barrett Cancer Center | |
| Cincinnati, Ohio, United States, 45219 | |
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Cancer Care Associates - Mercy Campus | |
| Oklahoma City, Oklahoma, United States, 73120 | |
| Cancer Care Associates | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Oregon | |
| Oncology/Hematology, Kaiser Permanente Northwest | |
| Portland, Oregon, United States, 97227 | |
| United States, Pennsylvania | |
| Oncology Hematology of Lehigh Valley, PC | |
| Bethlehem, Pennsylvania, United States, 18015 | |
| Medical Oncology Associates of Wyoming Valley, PC | |
| Kingston, Pennsylvania, United States, 18704 | |
| United States, South Carolina | |
| Santee Hematology/Oncology | |
| Sumter, South Carolina, United States, 29150 | |
| WJB Dorn VA Medical Center | |
| Columbia, South Carolina, United States, 29209 | |
| Liberty Hematology/Oncology | |
| Columbia, South Carolina, United States, 29203 | |
| Cancer Centers of the Carolinas | |
| Seneca, South Carolina, United States, 29672 | |
| Charleston Hematology Oncology P.A. | |
| Charleston, South Carolina, United States, 29403 | |
| United States, Tennessee | |
| Thompson Cancer Survival Center | |
| Knoxville, Tennessee, United States, 37916 | |
| Boston Baskin Cancer Group | |
| Memphis, Tennessee, United States, 38104 | |
| United States, Texas | |
| University of Texas, MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Lone Star Oncology Consultants, P.A. | |
| Austin, Texas, United States, 78759 | |
| Hope Oncology | |
| Richardson, Texas, United States, 75080 | |
| Hematology & Oncology Associates of South Texas | |
| San Antonio, Texas, United States, 78229 | |
| Cancer Specialists of South Texas, PA | |
| Corpus Christi, Texas, United States, 78412 | |
| West Texas Cancer Center | |
| Odessa, Texas, United States, 79761 | |
| Texas Oncology, P.A. | |
| Dallas, Texas, United States, 75246 | |
| South Austin Cancer Center | |
| Austin, Texas, United States, 78745 | |
| Texas Cancer Center at Medical City | |
| Dallas, Texas, United States, 75230 | |
| Texas Oncology, P.A. | |
| Arlington, Texas, United States, 76012 | |
| Texas Oncology, P.A. | |
| Garland, Texas, United States, 75042 | |
| Tyler Cancer Center | |
| Tyler, Texas, United States, 75702 | |
| Texas Oncology, P.A. | |
| Fort Worth, Texas, United States, 76104 | |
| Texoma Cancer Center | |
| Wichita Falls, Texas, United States, 76310 | |
| Allison Cancer Center | |
| Midland, Texas, United States, 79701 | |
| United States, Utah | |
| Utah Cancer Specialists | |
| Salt Lake City, Utah, United States, 84106 | |
| United States, Virginia | |
| Danville Hematology & Oncology, Inc. | |
| Danville, Virginia, United States, 24541 | |
| Virginia Cancer Institute | |
| Richmond, Virginia, United States, 23230 | |
| Arlington Fairfax Hematology Oncology | |
| Arlington, Virginia, United States, 22205 | |
| Stark MD, PC | |
| Portsmouth, Virginia, United States, 23707 | |
| Hematology Oncology Patient Enterprises, Center for Cancer Care | |
| Charlottesville, Virginia, United States, 22902 | |
| Virginia Oncology Associates | |
| Norfolk, Virginia, United States, 23502 | |
| United States, Washington | |
| Yakima Regional Cancer Care Center, Internal Medicine Associates of Yakima, Inc. | |
| Yakima, Washington, United States, 98902 | |
| United States, West Virginia | |
| Morgantown Internal Medicine Group | |
| Morgantown, West Virginia, United States, 26505 | |
| Austria | |
| Kaiser-Franz-Josef-Spital | |
| Wien, Austria, A-1100 | |
| Allgemeines offentliches Krankenhaus der barmherzigen Schwestern vom Heiligen Kreuz Pneumologie | |
| Wels, Austria, 4600 | |
| Sozialmedizinisches Zentrum | |
| Wien, Austria, 1145 | |
| Canada, Ontario | |
| Algoma Regional Cancer Program - Sault Area Hospital | |
| Sault Ste. Marie, Ontario, Canada, P6A 2C4 | |
| Humber River Regional Hospital | |
| Weston, Ontario, Canada, M9N 1N8 | |
| Canada, Quebec | |
| S.M.B.D. Jewish General Hospital | |
| Montreal, Quebec, Canada, H3T 1E2 | |
| France | |
| Centre Hospitalier General de la Region Annecienne | |
| Annecy Cedex, France, 47011 | |
| DOP International | |
| Creteil, France, 94010 | |
| Hopital Saint Anne | |
| Toulon Naval, France, 83800 | |
| Centre Hospitalier | |
| Villefranche sur Soane, France, 69655 | |
| Service de Pneumology, Hopital Adulte de Brabois | |
| Vandoeuvre les Nancy, France, 54511 | |
| CHRU Hopital de Bois Guillaume | |
| Bois Guillaume, France, 76230 | |
| Centre Hospitalier du Pays d'Aix | |
| Aix en Provence, Cedex 01, France, 13616 | |
| CHU - Hopital Nord | |
| St. Etienne, Cedex 2, France, 42055 | |
| Hopital Saint Antoine | |
| Paris, Cedex 12, France, 75571 | |
| Centre Hospitalier d'Antibes-Juan-Les-Pins | |
| Antibes Cedex, France, 06606 | |
| Hopital de Draguignan | |
| Draguignan, France, 83300 | |
| Centre Regional de Lutte contre le Cancer (CRLC), Val d'Aurelle-Paul Lamarque | |
| Montpellier, Cedex 05, France, 34298 | |
| Centre Hospitalier General | |
| Gap Cedex, France, 05007 | |
| Hopital du Cluzeau | |
| Limoges Cedex, France, 87042 | |
| CHU Hopital St. Marguerite | |
| Marseille, Cedex 09, France, 29274 | |
| Germany | |
| Aesklepios-Fachkliniken Muchen-Gauting | |
| Gauting, Germany, D-82131 | |
| Krankenhaus GroBhansdorf, Zentrum fur Pneumologie und Thoraxchirurgie | |
| GroBhansdorf, Germany, 22927 | |
| Ludwig-Maximilians Universitat Munchen | |
| Munchen, Germany, 80336 | |
| Charite Universitatsklinikum der Humboldt-Universitat zu Berlin | |
| SchumannstraBe, Berlin, Germany, 10117 | |
| Dept. of Internal Medicine, St. Nikolaus-Stiftshospital Andernach | |
| Andernach, Germany, D-56626 | |
| Spain | |
| Hospital Universitario Doctor Peset | |
| Valencia, Spain, 46 017 | |
| Hospital Clinico Universitario, Servicio Hematologia y Oncologia | |
| Valencia, Spain, 46044 | |
| Hospital de Sagunto Servicio de Oncologia | |
| Valencia, Spain, 46520 | |
| Hospital Provincial de Castellon | |
| Castellon, Spain, 12002 | |
| Hospital Universitario La Fe Servicio de Oncologia | |
| Valencia, Spain, 46018 | |
| Hospital Clinico San Carlos | |
| Madrid, Spain, 28040 | |
| Hospital Arnau de Villanova, Servicio de Oncologia | |
| Valencia, Spain, 46039 | |
| Study Director: | Mack Mabry, M.D. | Ligand Pharmaceuticals |
More Information
| Study ID Numbers: | L1069-48 |
| Study First Received: | December 31, 2002 |
| Last Updated: | July 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00050960 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
NSCLC Targretin Retinoid Bexarotene |
|
Thoracic Neoplasms Anticarcinogenic Agents Respiratory Tract Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Physiological Effects of Drugs Protective Agents Pharmacologic Actions Carcinoma |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Bexarotene Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
