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A Multicenter, Open-Label, Phase IIIb Trial of Tarceva (Erlotinib Hydrochloride) in Patients With Advanced Non-Small Cell Lung Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Lung Cancer, Non-small-cell Lung Carcinoma

Thank you

Trial Information

A Multicenter, Open-Label, Phase IIIb Trial of Tarceva (Erlotinib Hydrochloride) in Patients With Advanced Non-Small Cell Lung Cancer


Inclusion Criteria:



- Written (signed) informed consent(s)

- Inoperable and incurable, locally advanced, recurrent or metastatic NSCLC

- Relapse following standard chemotherapy (combination chemotherapy such as two-drug
combination chemotherapy, or a single-agent chemotherapy agent for elderly or poor
performance status patients)

- Age >=18 years

- ECOG performance status of 0 to 3

- Recovered from the toxic effects of prior therapy

- Able to comply with study and follow-up procedures

- Able to take oral medication

- Use of an effective means of contraception (for patients with reproductive potential)

- Granulocyte count >=1.0 x 10^9/L

- Platelet count >=75 x 10^9/L

- Serum bilirubin <1.5 x upper limit of normal (ULN)

- SGOT (AST) <2 x ULN unless elevation is clearly due to liver metastases; then SGOT
(AST) must be <5 x ULN

- Serum creatinine <=1.5 mg/dL

Exclusion Criteria:

- Any unstable systemic disease (including active infection, unstable angina,
congestive heart failure, myocardial infarction within the last 6 months, hepatic,
renal, or metabolic disease)

- Prior therapy with any systemic HER1/EGFR small molecule inhibitor, including
gefitinib (Iressa), erlotinib (Tarceva), or other investigational agents in this
class

- History of another malignancy in the past 2 years unless the malignancy has been
adequately treated and is associated with a 5-year anticipated survival of >=90%

- Known central nervous system (CNS) metastases that have not yet been definitively
treated with surgery and/or radiation or that are symptomatic or unstable

- Nursing mothers or pregnant females

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

OSI3199g

NCT ID:

NCT00091663

Start Date:

August 2004

Completion Date:

August 2005

Related Keywords:

  • Lung Cancer
  • Non-Small-Cell Lung Carcinoma
  • Advanced non-small cell lung cancer
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Mary Bird Perkins Cancer CenterBaton Rouge, Louisiana  70809
Providence Alaska Medical CenterAnchorage, Alaska  99508
Florida Hospital Cancer InstituteOrlando, Florida  32804
Southwest Regional Cancer CenterAustin, Texas  78705
Comprehensive Cancer InstituteHuntsville, Alabama  35801
Ocala Oncology CenterOcala, Florida  34474
Hematology Oncology AssociatesAtlantis, Florida  33462
Sioux Valley ClinicSioux Falls, South Dakota  57104
Oncology Care Associates, P.L.L.C.Saint Joseph, Michigan  49085
Consultants in Blood Disorders and CancerLouisville, Kentucky  40207
Gaston Hematology and OncologyGastonia, North Carolina  28054
Tower Hematology Oncology Medical GroupLos Angeles, California  90048
Florida Oncology AssociatesOrange Park, Florida  32073
South Carolina Oncology Associates, PAColumbia, South Carolina  29210
Berkshire Hematology Oncology, PCPittsfield, Massachusetts  01201
Lone Star Oncology Consultants, PAAustin, Texas  78759
Cascade Cancer CenterKirkland, Washington  98034-3013
Osceola Cancer CenterKissimmee, Florida  34741
Charleston Cancer CenterCharleston, South Carolina  29406
The Center for Cancer and Hematologic DiseaseCherry Hill, New Jersey  08003
The Sarah Cannon Cancer CenterNashville, Tennessee  37203
Hematology Oncology Consultants, Inc.Columbus, Ohio  43235
Gabrail Cancer CenterCanton, Ohio  44718
Maine Center for Cancer Medicine & Blood DisordersScarborough, Maine  04074
Bay Area OncologyTampa, Florida  33607
Piedmont Oncology SpecialistsCharlotte, North Carolina  28207
Northwest Medical SpecialistsArlington Heights, Illinois  60004
Florida Cancer InstituteNew Port Richey, Florida  34652
Santee Hematology/OncologySumter, South Carolina  29150
Kentucky Cancer ClinicPikeville, Kentucky  41501
MetCare OncologyOrmond Beach, Florida  32174
Little Rock Hematology Oncology AssociatesLittle Rock, Arkansas  72205
Oncology and Hematology Associates of West Broward P.A.Tamarac, Florida  33321
The Family Cancer CenterCollierville, Tennessee  38017
Clinical Trials and Research Associates, Inc.Montebello, California  60460
Space Coast Medical AssociatesCocoa Beach, Florida  32931
Texas Cancer Associates, LLPDallas, Texas  75231
Florida Wellcare AllianceInverness, Florida  34452
St. Luke's Mountain States Tumor InstituteBoise, Idaho  83712
Cancer and Blood Institute Medical GroupRancho Mirage, California  92270
Hematology-Oncology Specialist, Center for Cancer CareHuntsville, Alabama  35801
Palo Verde Hematology/Oncology, Ltd.Glendale, Arizona  85204
Arizona Hematology Oncology, PCTucson, Arizona  85704
Southbay Oncology Hematology PartnersCampbell, California  95008
Antelope Valley Cancer CenterLancaster, California  93534
Los Palos Oncology and Hematology CenterSalinas, California  93901
Naveen Gupta, MD, Inc.Upland, California  91786
Hematology Oncology, PCStamford, Connecticut  06902
Lee Cancer ClinicFort Myers, Florida  33919
Mid-Florida Hematology & Oncology Centers, P.A.Orange City, Florida  32763
Hematology & Oncology of NE Georgia, PCAthens, Georgia  30607
Hematology Oncology ConsultantsNaperville, Illinois  60540
Cedar Valley Medical Specialists, PCWaterloo, Iowa  50702
Hematology Oncology ClinicBaton Rouge, Louisiana  70808
Louisiana Oncology Associates, PMCLafayette, Louisiana  70506
Annapolis Medical Specialists, LLCAnnapolis, Maryland  21401
Maryland Hematology/Oncology Associates, PABaltimore, Maryland  21236
Center for Cancer and Blood Disorders, P.C.Bethesda, Maryland  20817-7847
West Michigan Regional Cancer & Blood CenterFree Soil, Michigan  49411
Kalamazoo Hematology and OncologyKalamazoo, Michigan  49048
Essex Oncology of North JerseyBelleville, New Jersey  07109
Combined Hematology Oncology Practice of New JerseyJersey City, New Jersey  07306
Hematology Oncology Associates of Western Suffolk, PCBay Shore, New York  11706
Nassau Hematology Oncology, P.C.Lake Success, New York  11042
Crystal Run HealthcareMiddletown, New York  10941
Westchester Hematology Oncology AssociatesMount Kisco, New York  10549
Upstate NY Cancer Research and Education FoundationRochester, New York  14623
Staten Island Medical GroupStaten Island, New York  10301
Cancer Care of WNCAsheville, North Carolina  28801
Northwestern Carolina Oncology & Hematology, PAHickory, North Carolina  28602
Lake Norman Hematology/ Oncology SpecialistsMooresville, North Carolina  28117
The Gerad Center for Cancer TreatmentLima, Ohio  45805
Ohio Cancer Specialists, Inc.Mansfield, Ohio  44907
Signal Point Hematology/Oncology, Inc.Middletown, Ohio  45042
Comprehensive Cancer CenterOklahoma City, Oklahoma  73112
Oncology Hematology Associates of Northern Pennsylvania, PCDubois, Pennsylvania  15801
Satish A. Shah, MD, PCGettysburg, Pennsylvania  17325
Drs. Sambandam & Joseph Associates, Inc.Cranston, Rhode Island  02920
Blue Ridge Medical SpecialistsBristol, Tennessee  37620
C. Michael Jones, MD PCGermantown, Tennessee  38138
McLeod Cancer & Blood CenterJohnson City, Tennessee  37604
Coastal Bend Oncology HematologyCorpus Christi, Texas  78404
Center for Oncology Research and Treatment P. A.Dallas, Texas  75230
Texas Hematology/Oncology Center, P.A.Dallas, Texas  75234
Steve Perkins, MD, PADallas, Texas  75235
Utah Hematology and OncologyOgden, Utah  84403
Rutland Regional Medical CenterRutland, Vermont  05701
Cancer Outreach Association, LLCAbingdon, Virginia  24211
Arlington Fairfax Hematology Oncology, P.C.Arlington, Virginia  22205
Lynchburg Hematology Oncology Clinic, Inc.Lynchburg, Virginia  24501
NW Cancer SpecialistsVancouver, Washington  98684
Ministry Medical GroupRhinelander, Wisconsin  54501