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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 ClinicMarshfield, Wisconsin  54449
Texas Oncology, P.A.Dallas, Texas  75246
Virginia Oncology AssociatesNewport News, Virginia  23606
Ocala Oncology CenterOcala, Florida  34474
Maine Center for Cancer Medicine and Blood DisordersScarborough, Maine  04074
Missouri Cancer AssociatesColumbia, Missouri  65201
Florida Oncology AssociatesOrange Park, Florida  32073
Hope CenterTerre Haute, Indiana  47809
Cancer Care AssociatesTulsa, Oklahoma  74136
St. Joseph Oncology, Inc.Saint Joseph, Missouri  64506
New York Oncology Hematology, P.C.Albany, New York  12208
Arizona Oncology AssociatesTucson, Arizona  85712-2254
Cancer Centers of Florida, P.A.Orlando, Florida  
Gabrail Cancer CenterCanton, Ohio  44718
Illinois Cancer CarePeoria, Illinois  61615
Medical Oncology AssociatesKingston, Pennsylvania  18704
Medical Oncology Associates of AugustaAugusta, Georgia  30901
Central Indiana Cancer CentersIndianapolis, Indiana  46227
Tulane University Health Sciences CenterNew Orleans, Louisiana  70112
Texoma Cancer CenterWichita Falls, Texas  76310
Lineberger Comprehensive Cancer CenterChapel Hill, North Carolina  27599-7305
Little Rock Hematology Oncology AssociatesLittle Rock, Arkansas  72205
Joliet Oncology-Hematology Associates, Ltd.Flossmoor, Illinois  60422
Center for Cancer and Blood DisordersBethesda, Maryland  20817
Piedmont Hematology Oncology AssociatesWinston Salem, North Carolina  27103
Cancer Center of KansasWichita, Kansas  67214
Kalamazoo Hematology and OncologyKalamazoo, Michigan  49048
Northwest Alabama Cancer CenterMuscle Shoals, Alabama  35661
Coastal Bend Cancer CenterCorpus Christi, Texas  78404
University of Colorado Health Science CentreDenver, Colorado  80010-0510
UPMC Cancer PavilionPittsburgh, Pennsylvania  15232
Advanced Medical SpecialtiesMiami, Florida  33176
SUNY Upstate Medical University - Regional Oncology CenterSyracuse, New York  13210
Cedars-Sinai Outpatient Cancer CenterLos 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 OncologyPensacola, Florida  32504
Cancer & Hematology Specialists of Chicago (Main)Niles, Illinois  60714
Cancer Care at Blessing HospitalQuincy, Illinois  62301
Kansas City Cancer Center (Main)Overland Park, Kansas  66210
Jayne Gurtler MD, Laura Brizn MD, Angelo Russo MD, and Janet Burroff MD, APMCMetairie, Louisiana  70006
Sinai Hospital of Baltimore, Inc.Baltimore, Maryland  21215
Alliance Hematology Oncology, P.A. (Main)Westminster, Maryland  21157
Michigan Hematology & Oncology InstituteSouthgate, Michigan  48195
University of Minnesota Medical Center, Cancer CenterMinneapolis, Minnesota  55455
Comprehensive Care Centers of Nevada (Main)Las Vegas, Nevada  89169
Regional Cancer CareDurham, 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 HospitalPhiladelphia, Pennsylvania  19107
Cancer Centers of the Carolinas (Main)Greenville, South Carolina  29615
The Sarah Cannon Research Institute/TN OncologyNashville, 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 OncologyOdessa, Texas  79761
Fairfax Northern Virginia Hematology/OncologyFairfax, Virginia  22031
Blue Ridge Cancer CareRoanoke, Virginia  24019
Northwest Cancer Specialists - Vancouver (Main)Vancouver, Washington  98684