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A Study to Evaluate Tarceva in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

28. februar 2014 opdateret af: Genentech, Inc.

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

This is a Phase IIIb, multicenter, open-label trial of daily oral Tarceva in patients with advanced (inoperable Stage IIIb or IV) NSCLC who have progressed following standard chemotherapy treatment.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Medicin: Tarceva (erlotinib HCl)

Undersøgelsestype

Interventionel

Tilmelding

5000

Fase

Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Alabama
  - Huntsville, Alabama, Forenede Stater, 35801
    - Comprehensive Cancer Institute
  - Huntsville, Alabama, Forenede Stater, 35801
    - Hematology-Oncology Specialist, Center for Cancer Care
- Alaska
  - Anchorage, Alaska, Forenede Stater, 99508
    - Providence Alaska Medical Center
- Arizona
  - Glendale, Arizona, Forenede Stater, 85204
    - Palo Verde Hematology/Oncology, Ltd.
  - Tucson, Arizona, Forenede Stater, 85704
    - Arizona Hematology Oncology, PC
- Arkansas
  - Little Rock, Arkansas, Forenede Stater, 72205
    - Little Rock Hematology Oncology Associates
- California
  - Beverly Hills, California, Forenede Stater, 90211
    - Tower Hematology Oncology Medical Group
  - Campbell, California, Forenede Stater, 95008
    - Southbay Oncology Hematology Partners
  - Lancaster, California, Forenede Stater, 93534
    - Antelope Valley Cancer Center
  - Montebello, California, Forenede Stater, 90640
    - Clinical Trials and Research Associates, Inc.
  - Rancho Mirage, California, Forenede Stater, 92270
    - Cancer and Blood Institute Medical Group
  - Salinas, California, Forenede Stater, 93901
    - Los Palos Oncology and Hematology Center
  - Upland, California, Forenede Stater, 91786
    - Naveen Gupta, MD, Inc.
- Connecticut
  - Stamford, Connecticut, Forenede Stater, 06902
    - Hematology Oncology, PC
- Florida
  - Fort Myers, Florida, Forenede Stater, 33919
    - Lee Cancer Clinic
  - Inverness, Florida, Forenede Stater, 34452
    - Florida Wellcare Alliance
  - Jacksonville, Florida, Forenede Stater, 32207
    - Florida Oncology Associates
  - Kissimmee, Florida, Forenede Stater, 34741
    - Osceola Cancer Center
  - New Port Richey, Florida, Forenede Stater, 34652
    - Florida Cancer Institute
  - Ocala, Florida, Forenede Stater, 34474
    - Ocala Oncology Center
  - Orange City, Florida, Forenede Stater, 32763
    - Mid-Florida Hematology & Oncology Centers, P.A.
  - Orlando, Florida, Forenede Stater, 32804
    - Florida Hospital Cancer Institute
  - Ormond Beach, Florida, Forenede Stater, 32174
    - Metcare Oncology
  - Pensacola, Florida, Forenede Stater, 32501
    - Hematology Oncology Associates
  - Tamarac, Florida, Forenede Stater, 33321
    - Oncology and Hematology Associates of West Broward P.A.
  - Tampa, Florida, Forenede Stater, 33607
    - Bay Area Oncology
  - Titusville, Florida, Forenede Stater, 32796
    - Space Coast Medical Associates
- Georgia
  - Athens, Georgia, Forenede Stater, 30607
    - Hematology & Oncology of NE Georgia, PC
- Idaho
  - Boise, Idaho, Forenede Stater, 83712
    - St. Luke's Mountain States Tumor Institute
- Illinois
  - Arlington Heights, Illinois, Forenede Stater, 60005
    - Northwest Medical Specialists
  - Naperville, Illinois, Forenede Stater, 60540
    - Hematology Oncology Consultants
- Iowa
  - Waterloo, Iowa, Forenede Stater, 50702
    - Cedar Valley Medical Specialists, PC
- Kentucky
  - Hazard, Kentucky, Forenede Stater, 41701
    - Kentucky Cancer Clinic
  - Louisville, Kentucky, Forenede Stater, 40207
    - Consultants in Blood Disorders and Cancer
- Louisiana
  - Baton Rouge, Louisiana, Forenede Stater, 70809
    - Mary Bird Perkins Cancer Center
  - Baton Rouge, Louisiana, Forenede Stater, 70808
    - Hematology Oncology Clinic
  - Lafayette, Louisiana, Forenede Stater, 70506
    - Louisiana Oncology Associates, PMC
- Maine
  - Scarborough, Maine, Forenede Stater, 04074
    - Maine Center for Cancer Medicine & Blood Disorders
- Maryland
  - Annapolis, Maryland, Forenede Stater, 21401
    - Annapolis Medical Specialists, LLC
  - Baltimore, Maryland, Forenede Stater, 21236
    - Maryland Hematology/Oncology Associates, PA
  - Bethesda, Maryland, Forenede Stater, 20817-7847
    - Center for Cancer and Blood Disorders, P.C.
- Massachusetts
  - Pittsfield, Massachusetts, Forenede Stater, 01201
    - Berkshire Hematology Oncology, PC
- Michigan
  - Free Soil, Michigan, Forenede Stater, 49411
    - West Michigan Regional Cancer & Blood Center
  - Kalamazoo, Michigan, Forenede Stater, 49048
    - Kalamazoo Hematology and Oncology
  - St. Joseph, Michigan, Forenede Stater, 49085
    - Oncology Care Associates, P.L.L.C.
- New Jersey
  - Belleville, New Jersey, Forenede Stater, 07109
    - Essex Oncology of North Jersey
  - Cherry Hill, New Jersey, Forenede Stater, 08003
    - The Center for Cancer and Hematologic Disease
  - Jersey City, New Jersey, Forenede Stater, 07306
    - Combined Hematology Oncology Practice of New Jersey
- New York
  - Bay Shore, New York, Forenede Stater, 11706
    - Hematology Oncology Associates of Western Suffolk, PC
  - Lake Success, New York, Forenede Stater, 11042
    - Nassau Hematology Oncology, P.C.
  - Middletown, New York, Forenede Stater, 10941
    - Crystal Run Healthcare
  - Mount Kisco, New York, Forenede Stater, 10549
    - Westchester Hematology Oncology Associates
  - Rochester, New York, Forenede Stater, 14623
    - Upstate NY Cancer Research and Education Foundation
  - Staten Island, New York, Forenede Stater, 10301
    - Staten Island Medical Group
- North Carolina
  - Asheville, North Carolina, Forenede Stater, 28801
    - Cancer Care of WNC
  - Gastonia, North Carolina, Forenede Stater, 28054
    - Gaston Hematology and Oncology
  - Hickory, North Carolina, Forenede Stater, 28602
    - Northwestern Carolina Oncology & Hematology, PA
  - Monroe, North Carolina, Forenede Stater, 28112
    - Piedmont Oncology Specialists
  - Mooresville, North Carolina, Forenede Stater, 28117
    - Lake Norman Hematology/ Oncology Specialists
- Ohio
  - Canton, Ohio, Forenede Stater, 44718
    - Gabrail Cancer Center
  - Columbus, Ohio, Forenede Stater, 43235
    - Hematology Oncology Consultants, Inc.
  - Lima, Ohio, Forenede Stater, 45805
    - The Gerad Center for Cancer Treatment
  - Mansfield, Ohio, Forenede Stater, 44907
    - Ohio Cancer Specialists, Inc.
  - Middletown, Ohio, Forenede Stater, 45042
    - Signal Point Hematology/Oncology, Inc.
- Oklahoma
  - Oklahoma City, Oklahoma, Forenede Stater, 73112
    - Comprehensive Cancer Center
- Pennsylvania
  - Dubois, Pennsylvania, Forenede Stater, 15801
    - Oncology Hematology Associates of Northern Pennsylvania, PC
  - Gettysburg, Pennsylvania, Forenede Stater, 17325
    - Satish A. Shah, MD, PC
- Rhode Island
  - Cranston, Rhode Island, Forenede Stater, 02920
    - Drs. Sambandam & Joseph Associates, Inc.
- South Carolina
  - Charleston, South Carolina, Forenede Stater, 29406
    - Charleston Cancer Center
  - Columbia, South Carolina, Forenede Stater, 29210
    - South Carolina Oncology Associates, PA
  - Sumter, South Carolina, Forenede Stater, 29150
    - Santee Hematology/Oncology
- South Dakota
  - Sioux Falls, South Dakota, Forenede Stater, 57104
    - Sioux Valley Clinic
- Tennessee
  - Bristol, Tennessee, Forenede Stater, 37620
    - Blue Ridge Medical Specialists
  - Collierville, Tennessee, Forenede Stater, 38017
    - The Family Cancer Center
  - Germantown, Tennessee, Forenede Stater, 38138
    - C. Michael Jones, MD PC
  - Johnson City, Tennessee, Forenede Stater, 37604
    - McLeod Cancer & Blood Center
  - Nashville, Tennessee, Forenede Stater, 37203
    - The Sarah Cannon Cancer Center
- Texas
  - Austin, Texas, Forenede Stater, 78705
    - Southwest Regional Cancer Center
  - Austin, Texas, Forenede Stater, 78759
    - Lone Star Oncology Consultants, PA
  - Corpus Christi, Texas, Forenede Stater, 78404
    - Coastal Bend Oncology Hematology
  - Dallas, Texas, Forenede Stater, 75230
    - Center for Oncology Research and Treatment P. A.
  - Dallas, Texas, Forenede Stater, 75231
    - Texas Cancer Associates, LLP
  - Dallas, Texas, Forenede Stater, 75234
    - Texas Hematology/Oncology Center, P.A.
  - Dallas, Texas, Forenede Stater, 75235
    - Steve Perkins, MD, PA
- Utah
  - Ogden, Utah, Forenede Stater, 84403
    - Utah Hematology and Oncology
- Vermont
  - Rutland, Vermont, Forenede Stater, 05701
    - Rutland Regional Medical Center
- Virginia
  - Abingdon, Virginia, Forenede Stater, 24211
    - Cancer Outreach Association, LLC
  - Arlington, Virginia, Forenede Stater, 22205
    - Arlington Fairfax Hematology Oncology, P.C.
  - Lynchburg, Virginia, Forenede Stater, 24501
    - Lynchburg Hematology Oncology Clinic, Inc.
- Washington
  - Kirkland, Washington, Forenede Stater, 98034
    - Cascade Cancer Center
  - Vancouver, Washington, Forenede Stater, 98684
    - NW Cancer Specialists
- Wisconsin
  - Rhinelander, Wisconsin, Forenede Stater, 54501
    - Ministry Medical Group

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Genentech, Inc.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Spigel DR, Lin M, O'Neill V, Hainsworth JD. Final survival and safety results from a multicenter, open-label, phase 3b trial of erlotinib in patients with advanced nonsmall cell lung cancer. Cancer. 2008 Jun 15;112(12):2749-55. doi: 10.1002/cncr.23490.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2004

Studieafslutning (Faktiske)

1. august 2005

Datoer for studieregistrering

Først indsendt

15. september 2004

Først indsendt, der opfyldte QC-kriterier

15. september 2004

Først opslået (Skøn)

16. september 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. marts 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. februar 2014

Sidst verificeret

1. februar 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Avanceret ikke-småcellet lungekræft

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

OSI3199g

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .