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| Sponsor: | OSI Pharmaceuticals |
|---|---|
| Information provided by: | OSI Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00085826 |
Purpose
Taxotere has been approved by the FDA and is considered a standard treatment for patients with lung cancer who have failed prior platinum-containing regimens. The main purpose of this research study is to determine if Aptosyn, when given in combination with Taxotere, will result in prolonged survival when compared to Taxotere alone.
This study will also help determine tumor response rates, and the safety profile of Aptosyn in combination with Taxotere.
This study has been completed and a publication is pending.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small Cell Lung Cancer |
Drug: Exisulind |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase III, Randomized, Double-Blind, Multi-Center Study of the Efficacy of Taxotere (Docetaxel) in Combination With Aptosyn (Exisulind) Versus Taxotere (Docetaxel) and Placebo in Non-Small Cell Lung Cancer (NSCLC) Patients After Failure of Prior Platinum-Based Chemotherapy |
Eligibility| Accepts Healthy Volunteers: | No |
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Birmingham Hematology Oncology Associates | |
| Birmingham, Alabama, United States, 35205 | |
| Birmingham Hematology and Oncology Associates, LLC | |
| Birmingham, Alabama, United States, 35235 | |
| United States, Arizona | |
| Arizona Clinical Research Center | |
| Tucson, Arizona, United States, 85715 | |
| Northern Arizona Hematology and Oncology Associates | |
| Flagstaff, Arizona, United States, 86001 | |
| Hematology & Oncology Associates | |
| Phoenix, Arizona, United States, 85012 | |
| Northern Arizona Hematology & Oncology Associates | |
| Sedona, Arizona, United States, 86336 | |
| United States, Arkansas | |
| Arkansas Oncology Associates, PA | |
| Little Rock, Arkansas, United States, 72207 | |
| United States, California | |
| Pacific Coast Hematology/Oncology Medical Group, Inc. | |
| Fountain Valley, California, United States, 92708 | |
| Sharp Clinical Oncology Research | |
| San Diego, California, United States, 92123 | |
| California Cancer Care, Inc. | |
| Greenbrae, California, United States, 94904 | |
| Scripps Cancer Center | |
| SanDiego, California, United States, 92121 | |
| Redwood Regional Medical Group | |
| Santa Rosa, California, United States, 95403 | |
| United States, Colorado | |
| RMCC | |
| Denver, Colorado, United States, 80218 | |
| Rocky Mountain Cancer Centers | |
| Fort Collins, Colorado, United States, 80524 | |
| Rocky Mountain Cancer Center | |
| Boulder, Colorado, United States, 80304 | |
| Rocky Mountain Cancer Centers | |
| Colorado Springs, Colorado, United States, 80909 | |
| Rocky Mountain Cancer Centers | |
| Englewood, Colorado, United States, 80110 | |
| Rocky Mountain Cancer Centers | |
| Littleton, Colorado, United States, 80120 | |
| Rocky Mountain Cancer Centers | |
| Thornton, Colorado, United States, 80260 | |
| 12. Rocky Mountain Cancer Centers-Englewood | |
| Englewood, Colorado, United States, 80110 | |
| United States, Florida | |
| Ocala Oncology Center | |
| Ocala, Florida, United States, 34474 | |
| Lauderhill Lakes | |
| Plantation, Florida, United States, 33324 | |
| Florida Oncology Associates | |
| Jacksonville, Florida, United States, 32207 | |
| Florida Oncology Associates | |
| Orange Park, Florida, United States, 32073 | |
| Boca Raton Comprehensive Cancer Center | |
| Boca Raton, Florida, United States, 33428 | |
| South Florida Oncology & Hematology Consultants | |
| Lauderhill, Florida, United States, 33319 | |
| Cancer Centers of Florida | |
| Orlando, Florida, United States, 32806 | |
| Comprehensive Cancer Care Specialists at Boca Raton | |
| Boca Raton, Florida, United States, 33428 | |
| Florida Cancer Institute | |
| New Port Richey, Florida, United States, 34655 | |
| North Florida Hematology & Oncology Association | |
| Jacksonville, Florida, United States, 32204 | |
| United States, Illinois | |
| Onc/Hem Associates of Central Illinois | |
| Peoria, Illinois, United States, 61602 | |
| Evanston Northwestern Healthcare | |
| Evanston, Illinois, United States, 60201 | |
| Hematology Oncology Associates of Illinois | |
| Skokie, Illinois, United States, 60077 | |
| Northwest Medical Specialists, PC | |
| Niles, Illinois, United States, 60714 | |
| United States, Indiana | |
| Central Indiana Cancer Centers | |
| Indianapolis, Indiana, United States, 46227 | |
| United States, Iowa | |
| Iowa Cancer Care, PLC | |
| Cedar Rapids, Iowa, United States, 52403 | |
| Iowa Oncology Associates | |
| Cedar Rapids, Iowa, United States, 52403 | |
| United States, Maryland | |
| Central Maryland Oncology Group | |
| Towson, Maryland, United States, 21204 | |
| Central Maryland Oncology Center | |
| Columbia, Maryland, United States, 21044 | |
| United States, Massachusetts | |
| Impath Predictive Oncology | |
| Franklin, Massachusetts, United States, 02038 | |
| United States, Minnesota | |
| Minnesota Oncology Hematology, PA | |
| St. Paul, Minnesota, United States, 55102 | |
| Minnesota Oncology Hematology, PA | |
| Minneapolis, Minnesota, United States, 55404 | |
| United States, Missouri | |
| The Center for Cancer Care & Research | |
| St. Louis, Missouri, United States, 63141 | |
| Kansas City Oncology and Hematology Group | |
| Kansas City, Missouri, United States, 64111 | |
| Missouri Cancer Associates | |
| Columbia, Missouri, United States, 65201 | |
| United States, Montana | |
| Hematology Oncology Centers of the Northern Rockies | |
| Billings, Montana, United States, 59101 | |
| United States, New Mexico | |
| New Mexico Cancer Center Associates | |
| Santa Fe, New Mexico, United States, 87501 | |
| United States, New York | |
| North Shore Hematology/Oncology Associates, P.C. | |
| East Setauket, New York, United States, 11733 | |
| Cancer Research of Long Island | |
| Great Neck, New York, United States, 11023 | |
| HemOnCare, PC | |
| Brooklyn, New York, United States, 11235 | |
| Interlakes Oncology & Hematology, P.C. | |
| Rochester, New York, United States, 14623 | |
| New York Oncology Hematology | |
| Albany, New York, United States, 12208 | |
| New York Oncology Hematology, PC | |
| Albany, New York, United States, 12208 | |
| United States, North Carolina | |
| Northeastern Carolina Hematology & Oncology, PA | |
| Hickory, North Carolina, United States, 28602 | |
| Raleigh Hematology Oncology Clini | |
| Cary, North Carolina, United States, 27511 | |
| Piedmont Hematology Onccology Associates, P.A. | |
| Winston-Salem, North Carolina, United States, 27103 | |
| Asheville Hematology & Oncology Associates, PA | |
| Asheville, North Carolina, United States, 28801 | |
| Raleigh Hematology Oncology Clinic | |
| Raleigh, North Carolina, United States, 27609 | |
| Regional Hamatology Oncology Associates | |
| Durham, North Carolina, United States, 27704 | |
| Raleigh Hematology Oncology Clinic | |
| Raleigh, North Carolina, United States, 27607 | |
| United States, Ohio | |
| Dayton Oncology/Hematology, PA | |
| Kettering, Ohio, United States, 45409 | |
| United States, Oklahoma | |
| Cancer Care Associates - Baptist Campus | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| Cancer Care Associates | |
| Tulsa, Oklahoma, United States, 74136-1902 | |
| United States, Oregon | |
| Willamette Valley Cancer Center | |
| Eugene, Oregon, United States, 97401 | |
| United States, Pennsylvania | |
| Hematology & Oncolgy Assoc of NE PA | |
| Dunmore, Pennsylvania, United States, 18512 | |
| Medical Oncology Associates of Wymoning Valley, PC | |
| Kingston, Pennsylvania, United States, 18704 | |
| Temple Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Thomas Jefferson University Hospital | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Oncology-Hematology Associates | |
| Pittsburgh, Pennsylvania, United States, 15215 | |
| United States, South Carolina | |
| Cancer Centers of the Carolinas | |
| Greenville, South Carolina, United States, 29615 | |
| United States, Tennessee | |
| University of Tennessee Cancer Institute | |
| Memphis, Tennessee, United States, 38104 | |
| United States, Texas | |
| US Oncology Research | |
| Dallas, Texas, United States, 75204 | |
| Texas Cancer Center | |
| Ft. Worth, Texas, United States, 76104 | |
| The Texas Cancer Center - Dallas Southwest | |
| Dallas, Texas, United States, 75237 | |
| Texas Oncology, P.A | |
| Arlington, Texas, United States, 76012 | |
| Waco Cancer Care & Research Center | |
| Waco, Texas, United States, 76712 | |
| Texas Oncology, P.A. | |
| Bedford, Texas, United States, 76022 | |
| Texas Cancer Center of Mesquite | |
| Mesquite, Texas, United States, 75150 | |
| Texas Oncology, PA | |
| Irving, Texas, United States, 75061 | |
| Texas Oncology, PA | |
| Houston, Texas, United States, 77030 | |
| Texoma Cancer Center | |
| Denison, Texas, United States, 75020-2088 | |
| San Antonio Tumor and Blood Clinic | |
| Fredicksburg, Texas, United States, 78624 | |
| Mamie McFadden Ward Cancer Center | |
| Beaumont, Texas, United States, 77702-1449 | |
| Texas Oncology, PA | |
| Abilene, Texas, United States, 79601-2301 | |
| Texas Oncology, PA | |
| Houston, Texas, United States, 77029 | |
| Tyler Cancer Center | |
| Tyler, Texas, United States, 75702 | |
| Hematology Oncology Associates of South Texas | |
| San Antonio, Texas, United States, 78229 | |
| Deke Slayton Cancer Center | |
| Webster, Texas, United States, 77589 | |
| Texas Onclology, PA | |
| Dallas, Texas, United States, 75231 | |
| Texas Oncology, PA | |
| Houston, Texas, United States, 77024 | |
| West Texas Cancer Center | |
| Odessa, Texas, United States, 79761 | |
| Texas Oncology, PA | |
| Garland, Texas, United States, 75042-5788 | |
| Lake Vista Cancer Center | |
| Lewisville, Texas, United States, 75067 | |
| Texas Oncology, PA | |
| Houston, Texas, United States, 77074-1811 | |
| Texas Oncology, PA | |
| Fort Worth, Texas, United States, 76104 | |
| South Austin Cancer Center | |
| Austin, Texas, United States, 78745 | |
| Texas Cancer Center at Medical City | |
| Dallas, Texas, United States, 75230-2510 | |
| Texoma Cancer Center | |
| Wichita Falls, Texas, United States, 76310 | |
| Allison Cancer Center | |
| Midland, Texas, United States, 79701-5946 | |
| Texas Oncology, PA | |
| Dallas, Texas, United States, 75246 | |
| San Antonio Tumor and Blood Clinic | |
| San Antonio, Texas, United States, 78217 | |
| San Antonio, Texas, United States | |
| United States, Utah | |
| Utah Cancer Specialists | |
| Salt Lake City, Utah, United States, 84106 | |
| United States, Virginia | |
| Virginia Oncology Associates | |
| Norfolk, Virginia, United States, 23502 | |
| Virginia Oncology Associates | |
| Newport News, Virginia, United States, 23606 | |
| Fairfax Northern Virginia Hematology-Oncology, PC | |
| Fairfax, Virginia, United States, 22031 | |
| Oncology & Hematology Associates of South West Virginia, Inc. | |
| Salem, Virginia, United States, 24153 | |
| United States, Washington | |
| Ranier Oncology Professional Services | |
| Puyallup, Washington, United States, 98372 | |
| MultiCare Health System | |
| Tacoma, Washington, United States, 98405 | |
| Puget Sound Cancer Centers | |
| Edmonds, Washington, United States, 98026 | |
| Cancer Care Northwest | |
| Spokane, Washington, United States, 99218 | |
| Washington Cancer Center, P.C. Puget Sound Cancer Cente | |
| Seattle, Washington, United States, 98133 | |
| Northwest Cancer Specialists, PC | |
| Vancouver, Washington, United States, 98684 | |
| United States, Wisconsin | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792 | |
More Information
| Study ID Numbers: | 028 |
| Study First Received: | June 15, 2004 |
| Last Updated: | October 10, 2006 |
| ClinicalTrials.gov Identifier: | NCT00085826 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Lung Cancer NSCLC Non-small Cell Lung Cancer |
|
Anti-Inflammatory Agents Thoracic Neoplasms Anticarcinogenic Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Docetaxel Neoplasms by Site Respiratory Tract Diseases Sensory System Agents Lung Neoplasms Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Respiratory Tract Neoplasms |
Neoplasms by Histologic Type Cyclooxygenase Inhibitors Enzyme Inhibitors Sulindac sulfone Protective Agents Pharmacologic Actions Carcinoma Neoplasms Analgesics, Non-Narcotic Lung Diseases Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
