Erlotinib in Women With Previously Untreated Adenocarcinoma of the Lung
7. december 2019 opdateret af: Pasi A. Janne, MD, PhD
A Phase II Study of Erlotinib (OSI-774); Tarceva in Women With Previously Untreated Advance Adenocarcinoma of the Lung
The purpose of this trial is to figure out what effects (good or bad) the investigational drug agent called Tarceva (erlotinib; OSI-774) has on women with previously untreated adenocarcinoma.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Patients will start taking Tarceva daily by mouth on Day 1 and will continue taking this medication daily at home, until participation in the study ends.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
84
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Dana-Farber Cancer Institute
-
Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Forenede Stater, 02115
- Beth Israel Deaconess Medical Center
-
-
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
Kvinde
Beskrivelse
Inclusion Criteria:
- Female
- Diagnosis of adenocarcinoma of the lung
- Patient has had at least one core biopsy of her tumor
- Must be willing to undergo epidermal growth factor receptor (EGFR) mutation testing of her tumor
- Stage four (IV) or three (III) B non-small cell lung cancer
- Non-smoker or former smoker. Non-smoker is defined as a person who smoked 100 or less cigarettes in her lifetime while a former smoker is defined as a person who has quit smoking one or more years ago.
- Three or more weeks since last radiation therapy
- Three or more weeks since last major surgery
- Must at least be able to walk and capable of taking care of herself although unable to carry out work activities
- Life expectancy of 8 weeks or more
- Blood tests that show kidneys, liver and bone marrow to be working adequately
- Women of child-bearing potential must agree to use adequate contraception prior to study entry and for the entire time enrolled in study
Exclusion Criteria:
- Prior exposure to Tarceva (OSI-774, erlotinib)
- Uncontrolled central nervous system problems
- Prior chemotherapy regimen
- Difficulty swallowing
- A disease or disorder that interferes with ability to digest and absorb food
- Incomplete healing of previous oncologic or other major surgery
- Significant medical history or unstable medical condition such as heart failure, active infection, uncontrolled high blood pressure
- Pregnant or breast feeding
- A medical condition that could make it unsafe for patient to participate in this study
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
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Erlotinib
Erlotinib: 150 mg orally once daily without interruption Cycle duration considered 4 weeks and treatment duration indefinite until disease progression, unacceptable toxicity or withdrawal for other reasons.
|
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Response Rate (ORR)
Tidsramme: In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months.
|
ORR is defined as the percentage of participants who achieve partial response (PR) or better on treatment based on RECIST 1.0 criteria: For target lesions, complete response (CR) is disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD (both require a minimum of 4 weeks).
Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or appearance of one or more new target lesions.
Stable disease (SD) is neither PR nor PD.
For non-target lesions, PD is the appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions.
|
In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Response Rate (ORR) by EGFR Mutation Status
Tidsramme: In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months.
|
ORR is defined as the percentage of participants who achieve partial response (PR) or better on treatment based on RECIST 1.0 criteria: For target lesions, complete response (CR) is disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD (both require a minimum of 4 weeks).
Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or appearance of one or more new target lesions.
SD is neither PR nor PD.
For non-target lesions, PD is the appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions.
|
In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months.
|
|
Overall Survival (OS)
Tidsramme: In this study cohort, participants were followed for survival up to 155 months.
|
OS is defined as the time from study entry to death or date last known alive.
|
In this study cohort, participants were followed for survival up to 155 months.
|
|
Overall Survival by EGFR Mutation Status
Tidsramme: In this study cohort, participants were followed for survival up to 155 months.
|
OS is defined as the time from study entry to death or date last known alive.
|
In this study cohort, participants were followed for survival up to 155 months.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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
- Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, van Kooten M, Dediu M, Findlay B, Tu D, Johnston D, Bezjak A, Clark G, Santabarbara P, Seymour L; National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005 Jul 14;353(2):123-32. doi: 10.1056/NEJMoa050753.
- Perez-Soler R, Chachoua A, Hammond LA, Rowinsky EK, Huberman M, Karp D, Rigas J, Clark GM, Santabarbara P, Bonomi P. Determinants of tumor response and survival with erlotinib in patients with non--small-cell lung cancer. J Clin Oncol. 2004 Aug 15;22(16):3238-47. doi: 10.1200/JCO.2004.11.057.
- Janne PA, Engelman JA, Johnson BE. Epidermal growth factor receptor mutations in non-small-cell lung cancer: implications for treatment and tumor biology. J Clin Oncol. 2005 May 10;23(14):3227-34. doi: 10.1200/JCO.2005.09.985.
- Paez JG, Janne PA, Lee JC, Tracy S, Greulich H, Gabriel S, Herman P, Kaye FJ, Lindeman N, Boggon TJ, Naoki K, Sasaki H, Fujii Y, Eck MJ, Sellers WR, Johnson BE, Meyerson M. EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science. 2004 Jun 4;304(5676):1497-500. doi: 10.1126/science.1099314. Epub 2004 Apr 29.
Hjælpsomme links
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 (Faktiske)
1. november 2004
Primær færdiggørelse (Faktiske)
1. november 2008
Studieafslutning (Faktiske)
1. juli 2019
Datoer for studieregistrering
Først indsendt
29. august 2005
Først indsendt, der opfyldte QC-kriterier
29. august 2005
Først opslået (Skøn)
30. august 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. december 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. december 2019
Sidst verificeret
1. december 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer efter sted
- Karcinom
- Neoplasmer, kirtel og epitel
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Lungeneoplasmer
- Adenocarcinom
- Adenocarcinom i lunge
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Proteinkinasehæmmere
- Erlotinib hydrochlorid
Andre undersøgelses-id-numre
- 04-253
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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 .