- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01196078
A Study of Tarceva (Erlotinib) in Elderly Patients With Advanced Non-Small Cell Lung Cancer
29. juni 2015 oppdatert av: Hoffmann-La Roche
A Phase II Randomized Trial of Erlotinib or Vinorelbine in Chemo-naive, Advanced, Non-Small-Cell Lung Cancer Patients Aged 70 Years or Older in Taiwan
This study will compare the efficacy and safety of Tarceva (erlotinib) and vinorelbine in chemo-naive elderly patients with advanced non-small cell lung cancer.
Patients will be randomized to receive either Tarceva (150 mg po daily) or vinorelbine (60 mg/m2 on days 1 and 8 of cycle 1 and 80 mg/m2 for the other 21 days cycles).
The anticipated time on study treatment is until disease progression.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
114
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Taipei, Taiwan
-
-
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
70 år og eldre (Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Adult patients, >=70 years of age
- Non-small cell lung cancer
- Naive to prior chemotherapy or specific immunotherapy
- Presence of at least 1 measurable lesion
Exclusion Criteria:
- Active non-controlled infection or disease
- CNS metastases
- Any other malignancies (other than adequately treated basal cell cancer of skin, or in situ cancer of the cervix)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 1
|
150 mg, orally once a day for up to 6 cycles of 21 days each
|
Aktiv komparator: 2
|
60 mg/m2, orally on days 1 and 8 of cycle 1, 80 mg/m2 for the other cycles
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Percentage of Participants Achieving a Best Overall Response of Complete Response (CR) or Partial Response (PR)
Tidsramme: Screening, Day 1 of Cycles 3 and 5 and at End of treatment up to 1 year
|
CR was defined as disappearance of all target lesions.
PR was defined as at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Participants experiencing either a CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST) were classified as responders.
Participants with tumour assessment unevaluable were viewed as non-responders.
|
Screening, Day 1 of Cycles 3 and 5 and at End of treatment up to 1 year
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Percentage of Participants Achieving Disease Control
Tidsramme: Screening, Day 1 of Cycles 3 and 5 and at End of treatment up to 1 year
|
Disease control was defined as achieving a best overall response of CR, PR, or stable disease (SD) according to RECIST criteria.
Participants with tumor assessment unevaluable were viewed as uncontrolled.
|
Screening, Day 1 of Cycles 3 and 5 and at End of treatment up to 1 year
|
Duration of Response Among Participants Who Achieved Either a CR or PR
Tidsramme: Screening, Day 1 of Cycles 3 and 5, every 4th cycle during post-study treatment, and every 3 cycles during follow-up
|
Duration of response was defined similarly for complete and partial responders.
Complete response lasted from the date the complete response was first recorded to the date on which progressive disease was first noted or date of death.
Partial response lasted from the date of partial response to the date of the first observation of progressive disease or date of death.
|
Screening, Day 1 of Cycles 3 and 5, every 4th cycle during post-study treatment, and every 3 cycles during follow-up
|
Percentage of Participants With Disease Progression
Tidsramme: Day 1 of Cycles 1, 3, and 5 or first documentation of progressive disease or death
|
Progressive disease was defined using RECIST as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
|
Day 1 of Cycles 1, 3, and 5 or first documentation of progressive disease or death
|
Time to Disease Progression
Tidsramme: Day 1 of Cycles 1, 3, and 5 or first documentation of progressive disease or death
|
Time to disease progression was defined as the interval between the day of randomization and the first documentation of progressive disease or death.
|
Day 1 of Cycles 1, 3, and 5 or first documentation of progressive disease or death
|
Overall Survival: Percentage of Participants With an Progressive Disease or Death
Tidsramme: Day 1 of Cycles 1 through 6 to date of death or date of last follow-up assessment
|
Overall survival was defined as the time from the date of randomization to the date of death.
Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment.
Participants without follow-up assessment were censored at the day of last dose and participants with no postbaseline information were censored at the time of randomization.
Progressive disease was defined per RECIST as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
|
Day 1 of Cycles 1 through 6 to date of death or date of last follow-up assessment
|
Overall Survival: Time to Event
Tidsramme: Day 1 of Cycles 1 through 6 to date of death or date of last follow-up assessment
|
Overall survival was defined as the time from the date of randomization to the date of death.
Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment.
Participants without follow-up assessment were censored at the day of last dose and participants with no post baseline information were censored at the time of randomization.
Overall median time to event was assessed for the population that experienced an event.
|
Day 1 of Cycles 1 through 6 to date of death or date of last follow-up assessment
|
Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT) Questionnaire
Tidsramme: Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study
|
The FACT Questionnaire contains 4 general and 1 lung cancer symptom-specific subscale, including Physical Well-Being (PWB), Social/family Well-Being (SWB), Emotional Well-Being (EWB), Functional Well-Being (FWB), and the 8-item Lung Cancer Subscale (LCS) that assess symptoms commonly reported by participants with lung cancer.
Each subscale was assessed by a five-point scale from 0 (not at all) to 4 (very much) to determine the quality of life.
PWB, SWB and FWB scores ranged from 0-28 and EWB scores ranged from 0-24.
LCS scores ranged from 0-36.
For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'.
For other subscales and questionnaires, the higher score represented 'Worsened'.
Missing data were replaced by the valid post-baseline assessment before.
The FACT-L score ranges from 0 to 136, with higher scores indicating better quality of life.
|
Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study
|
Changes in Quality of Life as Measured by the FACT Questionnaire
Tidsramme: Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study
|
The FACT Questionnaire contains 4 general and 1 lung cancer symptom-specific subscale, including PWB, SWB, EWB, FWB, and the 8-item LCS that assess symptoms commonly reported by participants with lung cancer.
Each subscale was assessed by a five-point scale from 0 (not at all) to 4 (very much) to determine the quality of life.
PWB, SWB and FWB scores ranged from 0-28 and EWB scores ranged from 0-24.
LCS scores ranged from 0-36.
For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'.
For other subscales and questionnaires, the higher score represented 'Worsened'.
Missing data were replaced by the valid post-baseline assessment before.
For PWB, FWB, SWB, and EWB scores and disease-specific subscale score, response of down, up or no change were defined as score changes of less than or equal to (≤)2, greater than or equal to (≥)+2, or between these values.
|
Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study
|
Percentage of Participants With Changes in Quality of Life as Measured by FACT Questionnaire Scores by Category of Change
Tidsramme: Baseline and End of study
|
The FACT and the FACT-L contain 4 general and 1 lung cancer symptom-specific subscale, including PWB, SWB, EWB, FWB, and the 8-item LCS that assess symptoms commonly reported by participants with lung cancer.
For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'.
For other subscales and questionnaires, the higher score represented Worsened'.
For PWB, FWB, SWB, and EWB scores and disease-specific subscale score, higher scores indicated a better outcome; a response of down, up, or no change was defined as a score change of ≤ -2 (score down), ≥ +2 (score up), or between these values.
|
Baseline and End of study
|
Changes in Quality of Life as Assessed by FACT-L (Lung Symptoms) Questionnaire
Tidsramme: Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study
|
The LCS consists of 7 items of the FACT-L (3 items relating to breathing/dyspnea, and 1 item each relating to cough, weight loss, appetite, and cognition) rated on a five-point scale from 0 (not at all) to 4 (very much).
The LCS total score is the sum of the scores from the 7 items.
For clear thinking and good appetite, the higher score represented 'Improved'; for other subscales and questionnaires, the higher score represented 'Worsened'.
Missing data were replaced by the valid post-baseline assessment before.
The change of FACT-L subscore was the change from baseline to endpoint.
The LCS of FACT-L is an independently validated tool that measures the disease-related symptoms of lung cancer on an overall scale of 0 (most symptomatic) to 28 (asymptomatic).
|
Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study
|
Percentage of Participants With Changes in FACT-L (Lung Symptoms) by Category of Change
Tidsramme: Baseline and End of study
|
The LCS consists of 7 items of the FACT-L (3 items relating to breathing/dyspnea, and 1 item each relating to cough, weight loss, appetite, and cognition).
The LCS total score is the sum of the scores from the 7 items, each rated on a five-point scale from 0 (not at all) to 4 (very much).
For clear thinking and good appetite, the higher score represented 'Improved'; for other subscales and questionnaires, the higher score represented 'Worsened'.
For each FACT-L question, the response status was defined as down, up, or no change if the score at endpoint was smaller (score down), larger than (score up), or the same as (no change) that at baseline.
|
Baseline and End of study
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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. februar 2007
Primær fullføring (Faktiske)
1. desember 2010
Studiet fullført (Faktiske)
1. desember 2010
Datoer for studieregistrering
Først innsendt
3. september 2010
Først innsendt som oppfylte QC-kriteriene
3. september 2010
Først lagt ut (Anslag)
8. september 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
27. juli 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. juni 2015
Sist bekreftet
1. juni 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i luftveiene
- Neoplasmer
- Lungesykdommer
- Neoplasmer etter nettsted
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Karsinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karsinom, ikke-småcellet lunge
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitosemodulatorer
- Antineoplastiske midler, fytogene
- Proteinkinasehemmere
- Erlotinib hydroklorid
- Vinorelbin
Andre studie-ID-numre
- ML20322
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. .
Kliniske studier på Ikke-småcellet lungekreft
-
AHS Cancer Control AlbertaCross Cancer InstituteFullførtOmfattende Stage Small Cel Lung CancerCanada
-
Memorial Sloan Kettering Cancer CenterAktiv, ikke rekrutterendeB-celle lymfom | B-celle non-hodgkin lymfom | B Cell ALLForente stater
-
University of WashingtonNational Cancer Institute (NCI); National Comprehensive Cancer NetworkAvsluttetTilbakevendende mantelcellelymfom | Refraktært mantelcellelymfom | Ann Arbor Stage I Mantelcellelymfom | Ann Arbor Stage II mantelcellelymfom | Ann Arbor Stage III Mantle Cell Lymfom | Ann Arbor Stage IV Mantle Cell LymfomForente stater
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.UkjentTilbakefallende / Refractory Mantle Cell Lymfom (MCL)Kina
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeMantelcellelymfom | Blastoid Variant Mantle Cell Lymfom | Pleomorf variant av mantelcellelymfomForente stater
-
BeiGeneRekrutteringMantelcellelymfom | Residiverende mantelcellelymfom | Refractory Mantle Cell Lymfom (MCL)Forente stater, Kina, Israel, Belgia, Polen, Spania, Tyrkia, Brasil, Italia, Canada, Storbritannia, Frankrike, Tyskland, Argentina, Puerto Rico
-
City of Hope Medical CenterNational Cancer Institute (NCI)RekrutteringMantelcellelymfom | Blastoid Variant Mantle Cell Lymfom | Pleomorf variant av mantelcellelymfomForente stater
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeAnn Arbor stadium I grad 1 follikulært lymfom | Ann Arbor stadium I grad 2 follikulært lymfom | Ann Arbor stadium II grad 1 follikulært lymfom | Ann Arbor stadium II grad 2 follikulært lymfom | Ann Arbor Stage IV B-celle non-Hodgkin lymfom | Ann Arbor Stage I B-celle non-Hodgkin lymfom | Ann Arbor... og andre forholdForente stater
-
Xiangyang No.1 People's HospitalQingdao Haier Biotechnology Co.,Ltd.Har ikke rekruttert ennåB-celle lymfom refraktært | B-celle lymfom Tilbakevendende | NK CellKina
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)FullførtAnn Arbor stadium III grad 1 follikulært lymfom | Ann Arbor stadium III grad 2 follikulært lymfom | Ann Arbor Stage III Indolent voksen non-Hodgkin lymfom | Ann Arbor Stage IV Grad 1 Follikulært lymfom | Ann Arbor Stage IV Grad 2 Follikulært lymfom | Ann Arbor Stage IV Indolent voksen non-Hodgkin... og andre forholdForente stater
Kliniske studier på erlotinib [Tarceva]
-
National Cancer Institute (NCI)University of Chicago; City of Hope Medical Center; University of Southern... og andre samarbeidspartnereFullført
-
PfizerFullførtKarsinom, ikke-småcellet lungeForente stater
-
M.D. Anderson Cancer CenterFullførtAvansert kreftForente stater
-
Merck Sharp & Dohme LLCFullført
-
National Cancer Institute (NCI)FullførtCervical plateepitelkarsinom | Tilbakevendende livmorhalskreftForente stater
-
Grupo de Investigación Clínica en Oncología RadioterapiaFullførtPlateepitelkarsinom i hode og nakkeSpania
-
University of ChicagoNational Cancer Institute (NCI)FullførtOndartet peritoneal mesotheliomaForente stater
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Genentech, Inc.FullførtKarsinom, ikke-småcellet lungeForente stater
-
National Cancer Institute (NCI)FullførtTilbakevendende prostatakreft | Uspesifisert voksen solid svulst, protokollspesifikk | Tilbakevendende blærekreft | Stadium IV blærekreft | Tilbakevendende kreft i bukspyttkjertelen | Stadium III Bukspyttkjertelkreft | Stadium IV Bukspyttkjertelkreft | Mannlig brystkreft | Stage IV brystkreft | Stadium IV... og andre forholdForente stater
-
PharmaMarFullførtAvanserte ondartede solide svulsterSpania, Forente stater