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

28. februar 2014 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Legemiddel: Tarceva (erlotinib HCl)

Studietype

Intervensjonell

Registrering

5000

Fase

Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Genentech, Inc.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. august 2004

Studiet fullført (Faktiske)

1. august 2005

Datoer for studieregistrering

Først innsendt

15. september 2004

Først innsendt som oppfylte QC-kriteriene

15. september 2004

Først lagt ut (Anslag)

16. september 2004

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

4. mars 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. februar 2014

Sist bekreftet

1. februar 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Avansert ikke-småcellet lungekreft

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

OSI3199g

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .