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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Small Cell Lung Cancer

Thank you

Trial Information

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.


Inclusion Criteria:



- Histological or cytological diagnosis of SCLC at study entry according to the
International Association for the Study of Lung Cancer (IASLC) histopathologic
classification. Mixed or combined subtypes according to the IASLC are not allowed;

- SCLC that is either sensitive (defined as a response including stable disease to
first-line platinum-based chemotherapy, with subsequent progression >/= 90 days after
completing first-line chemotherapy) or refractory (defined as best response to
first-line platinum-based chemotherapy or progression < 90 days after completing
first-line chemotherapy);

- Extensive or limited disease; patients with limited disease who are candidates for
local or regional salvage radiation therapy must have been offered such treatment
prior to participation in this study;

- Radiographically documented progression after first-line treatment with
platinum-based chemotherapy;

- No more than 1 prior chemotherapy regimen;

- At least 18 years of age;

- ECOG performance status of 0 - 1

Exclusion Criteria:

- Chest radiotherapy with curative intent to the primary disease complex prior to first dose; CNS radiotherapy to all other areas
- Prior anthracycline, topotecan, or irinotecan treatment.

- Prior anthracycline or topotecan treatment.

- Patients with know history of seropositive human immunodeficiency virus (HIV) or
patients who are receiving immunosuppressive medications that would increase the risk
of serious neutropenic complications

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:

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.

Outcome Time Frame:

Until death from any cause

Safety Issue:

No

Principal Investigator

Markus Renschler, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation

Authority:

United States: Food and Drug Administration

Study ID:

AMR PH GL 2007 CL001

NCT ID:

NCT00547651

Start Date:

September 2007

Completion Date:

May 2011

Related Keywords:

  • Small Cell Lung Cancer
  • Small Cell Lung Cancer
  • Lung Cancer
  • Limited Disease Sensitive Small Cell Lung Cancer
  • Extensive Disease Sensitive Small Cell Lung Cancer
  • Limited Disease Refractory Small Cell Lung Cancer
  • Extensive Disease Refractory Small Cell Lung Cancer
  • Refractory Small Cell Lung Cancer
  • Sensitive Small Cell Lung Cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

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