AMR PH GL 2007 CL001 Phase 3 A Randomized, Open-Label, Multinational Phase 3 Trial Comparing Amrubicin Versus Topotecan in Patients With Extensive or Limited and Sensitive or Refractory Small Cell Lung Cancer After Failure of First-Line Chemotherapy
Small cell lung cancer represents approximately 13% of the cancers of the lung and presents
as extensive stage disease in 60% to 70% of patients. Sites of metastases include bone
(35%), liver (25%), bone marrow (20%), brain (10%), extrathoracic lymph nodes (5%), and
subcutaneous masses (5%). Small-cell lung cancer has prominent markers of neuroendocrine
differentiation.
The staging classification for SCLC is the 2-stage Veterans Administration Lung Study Group
system that categorizes patients as having limited or extensive disease. Limited stage SCLC
is disease confined to 1 hemithorax with or without adjacent mediastinal and/or
supraclavicular lymph node involvement, but without a pleural effusion. This extent of
disease can be included in a tolerable radiation field. Extensive-disease SCLC is any
disease beyond the definition of limited-stage disease.
There are few proven treatment options for SCLC patients who fail first-line chemotherapy.
New treatment strategies must be evaluated. The need to discover active agents with better
toxicity profiles continues to be of great importance. Amrubicin may be an effective
treatment for this population.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objective is to demonstrate superiority in overall survival of amrubicin compared with topotecan hydrochloride in patients with small cell lung cancer (SCLC) after failure of first-line chemotherapy.
Until death from any cause
No
Markus Renschler, M.D.
Study Director
Celgene Corporation
United States: Food and Drug Administration
AMR PH GL 2007 CL001
NCT00547651
September 2007
May 2011
Name | Location |
---|---|
Marshfield Clinic | Marshfield, Wisconsin 54449 |
Texas Oncology, P.A. | Dallas, Texas 75246 |
Virginia Oncology Associates | Newport News, Virginia 23606 |
Ocala Oncology Center | Ocala, Florida 34474 |
Maine Center for Cancer Medicine and Blood Disorders | Scarborough, Maine 04074 |
Missouri Cancer Associates | Columbia, Missouri 65201 |
Florida Oncology Associates | Orange Park, Florida 32073 |
Hope Center | Terre Haute, Indiana 47809 |
Cancer Care Associates | Tulsa, Oklahoma 74136 |
St. Joseph Oncology, Inc. | Saint Joseph, Missouri 64506 |
New York Oncology Hematology, P.C. | Albany, New York 12208 |
Arizona Oncology Associates | Tucson, Arizona 85712-2254 |
Cancer Centers of Florida, P.A. | Orlando, Florida |
Gabrail Cancer Center | Canton, Ohio 44718 |
Illinois Cancer Care | Peoria, Illinois 61615 |
Medical Oncology Associates | Kingston, Pennsylvania 18704 |
Medical Oncology Associates of Augusta | Augusta, Georgia 30901 |
Central Indiana Cancer Centers | Indianapolis, Indiana 46227 |
Tulane University Health Sciences Center | New Orleans, Louisiana 70112 |
Texoma Cancer Center | Wichita Falls, Texas 76310 |
Lineberger Comprehensive Cancer Center | Chapel Hill, North Carolina 27599-7305 |
Little Rock Hematology Oncology Associates | Little Rock, Arkansas 72205 |
Joliet Oncology-Hematology Associates, Ltd. | Flossmoor, Illinois 60422 |
Center for Cancer and Blood Disorders | Bethesda, Maryland 20817 |
Piedmont Hematology Oncology Associates | Winston Salem, North Carolina 27103 |
Cancer Center of Kansas | Wichita, Kansas 67214 |
Kalamazoo Hematology and Oncology | Kalamazoo, Michigan 49048 |
Northwest Alabama Cancer Center | Muscle Shoals, Alabama 35661 |
Coastal Bend Cancer Center | Corpus Christi, Texas 78404 |
University of Colorado Health Science Centre | Denver, Colorado 80010-0510 |
UPMC Cancer Pavilion | Pittsburgh, Pennsylvania 15232 |
Advanced Medical Specialties | Miami, Florida 33176 |
SUNY Upstate Medical University - Regional Oncology Center | Syracuse, New York 13210 |
Cedars-Sinai Outpatient Cancer Center | Los Angeles, California |
Cancer Care Associates of Fresno Medical Group, Inc. | Fresno, California 93720 |
Rocky Mountain Cancer Center - Midtown (Main) | Denver, Colorado 80218 |
Sacred Heart Medical Oncology | Pensacola, Florida 32504 |
Cancer & Hematology Specialists of Chicago (Main) | Niles, Illinois 60714 |
Cancer Care at Blessing Hospital | Quincy, Illinois 62301 |
Kansas City Cancer Center (Main) | Overland Park, Kansas 66210 |
Jayne Gurtler MD, Laura Brizn MD, Angelo Russo MD, and Janet Burroff MD, APMC | Metairie, Louisiana 70006 |
Sinai Hospital of Baltimore, Inc. | Baltimore, Maryland 21215 |
Alliance Hematology Oncology, P.A. (Main) | Westminster, Maryland 21157 |
Michigan Hematology & Oncology Institute | Southgate, Michigan 48195 |
University of Minnesota Medical Center, Cancer Center | Minneapolis, Minnesota 55455 |
Comprehensive Care Centers of Nevada (Main) | Las Vegas, Nevada 89169 |
Regional Cancer Care | Durham, North Carolina 27704 |
Cancer Centers of North Carolina (Main) | Raleigh, North Carolina 27607 |
Greater Dayton Cancer Center (Main) | Kettering, Ohio 45409 |
Willamette Valley Cancer Center (Main) | Eugene, Oregon 97401-8122 |
Thomas Jefferson Memorial Hospital | Philadelphia, Pennsylvania 19107 |
Cancer Centers of the Carolinas (Main) | Greenville, South Carolina 29615 |
The Sarah Cannon Research Institute/TN Oncology | Nashville, Tennessee 37203 |
Texas Oncology, P.A. (Main) | Dallas, Texas 75246 |
Texas Cancer Center at Medical City (Main) | Dallas, Texas 75230-2510 |
West Texas Cancer Center-Texas Oncology | Odessa, Texas 79761 |
Fairfax Northern Virginia Hematology/Oncology | Fairfax, Virginia 22031 |
Blue Ridge Cancer Care | Roanoke, Virginia 24019 |
Northwest Cancer Specialists - Vancouver (Main) | Vancouver, Washington 98684 |