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A Study of Tarceva (Erlotinib) in Combination With Avastin (Bevacizumab) in Patients With Advanced Non-Small Cell Lung Cancer.

4 novembre 2014 aggiornato da: Hoffmann-La Roche

A Randomized, Open-label Study Comparing the Anti-tumor Effect of Treatment With Tarceva Plus Avastin Versus Chemotherapy Plus Avastin in Patients With Advanced Non-small Cell Lung Cancer

This 2 arm study will compare the efficacy and safety of Tarceva plus Avastin, and chemotherapy plus Avastin, in the first-line treatment of patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg p.o. daily plus Avastin 15mg/kg i.v. every 3 weeks, or standard platinum-based chemotherapy (4-6 cycles) plus Avastin. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

124

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Australia
    • Victoria
      • East Bentleigh, Victoria, Australia, VIC 3165
      • Geelong, Victoria, Australia, 3220
  • Belgio
      • Leuven, Belgio, 3000
  • Corea, Repubblica di
      • Bundang City, Corea, Repubblica di, 463-802
      • Daegu, Corea, Repubblica di, 700-712
      • Gyeonggi-do, Corea, Repubblica di, 411-769
      • Incheon, Corea, Repubblica di, 405-760
      • Seoul, Corea, Repubblica di, 138-736
      • Seoul, Corea, Repubblica di, 110-744
      • Seoul, Corea, Repubblica di, 120-752
      • Seoul, Corea, Repubblica di, 135-710
      • Seoul, Corea, Repubblica di, 137-807
      • Suwon, Corea, Repubblica di
  • Francia
      • Bayonne, Francia, 64100
      • Dijon, Francia, 21079
      • Le Mans, Francia, 72037
      • Marseille, Francia, 13273
      • Paris, Francia, 75674
      • Strasbourg, Francia, 67091
      • Vandoeuvre-les-nancy, Francia, 54511
  • Italia
    • Friuli-Venezia Giulia
      • Aviano, Friuli-Venezia Giulia, Italia, 33081
    • Lombardia
      • Milano, Lombardia, Italia, 20133
    • Marche
      • Ancona, Marche, Italia, 60121
    • Toscana
      • Lido Di Camaiore, Toscana, Italia, 55043
  • Lituania
      • Kaunas, Lituania, 50009
      • Vilnius, Lituania, 08660
  • Olanda
      • 's Hertogenbosch, Olanda, 5211 RW
      • Amsterdam, Olanda, 1007 MB
      • Eindhoven, Olanda, 5623 EJ
      • Groningen, Olanda, 9713 GZ
      • Heerlen, Olanda, 6419 PC
      • Maastricht, Olanda, 6229 HX
      • Rotterdam, Olanda, 3045 PM
  • Polonia
      • Lodz, Polonia, 91-520
      • Lublin, Polonia, 20-950
      • Otwock, Polonia, 05-400
  • Regno Unito
      • Dudley, Regno Unito, DY1 2HQ
      • Guildford, Regno Unito, GU2 7XX
      • Manchester, Regno Unito, M2O 4BX
  • Romania
      • Bucuresti, Romania, 022328
      • Cluj Napoca, Romania, 400015
      • Timisoara, Romania, 1900
  • Singapore
      • Singapore, Singapore, 119074
  • Spagna
      • Alicante, Spagna, 3010
      • Barcelona, Spagna, 08035
      • La Coruña, Spagna, 15006
      • Madrid, Spagna, 28046
      • Madrid, Spagna, 28041
      • Madrid, Spagna, 28222
      • Malaga, Spagna, 29010
      • Sevilla, Spagna, 41014
  • Taiwan
      • Changhua, Taiwan, 500
      • Kaohsiung, Taiwan, 00833
      • Tainan, Taiwan, 710
      • Taipei, Taiwan
      • Taipei, Taiwan, 114
      • Taipei, Taiwan, 112

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • advanced (stage IIIb and IV) non-small cell lung cancer;
  • measurable disease;
  • ECOG PS 0-1.

Exclusion Criteria:

  • prior chemotherapy or treatment with another systemic anti-cancer agent;
  • radiotherapy within 4 weeks prior to first dose of study treatment;
  • CNS metastases;
  • other malignancies in past 5 years, except for adequately treated cancer in situ of the cervix, basal or squamous cell skin cancer.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Bevacizumab, Chemotherapy
Participants received bevacizumab, 15 milligrams (mg) per (/) kilogram (kg), intravenously (IV), on Day 1 of Cycles 1 through 7 until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received 4 to 6 cycles of a standard platinum-containing regimen of chemotherapy: either gemcitabine, 1250 mg/ square meter (m^2), IV, on Days 1 and 8 of Cycles 1 through 4 or 6, and cisplatin 80 mg/m^2, IV, on Day 1 of Cycles 1 through 4 or 6; or paclitaxel, 200 mg/m^2, IV, and carboplatin area under the curve (AUC) 6 mg/ milliliter (ml) multiplied by (*) minute (min) on Day 1 of Cycles 1 through 4 or 6. The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
Droga: Bevacizumab
15 mg/kg, IV, Day 1 of Cycles 1 through 7
Altri nomi:
  • Avastin
Droga: Standard platinum-based chemotherapy
At the discretion of the investigator
Sperimentale: Bevacizumab, Erlotinib
Participants received bevacizumab, 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib, 150 mg, orally (PO), daily until disease progression, unacceptable toxicity, death, or withdrawal.
Droga: Bevacizumab
15 mg/kg, IV, Day 1 of Cycles 1 through 7
Altri nomi:
  • Avastin
Droga: Erlotinib
150 mg, PO, daily
Altri nomi:
  • Tarceva

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With Disease Progression or Death
Lasso di tempo: Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
Progression-free survival (PFS) was defined as the time from randomization to disease progression or death, from any cause. Progressive disease (PD) was defined according to Response Criteria in Solid Tumors (RECIST) version (V) 1.0. For target lesions (TLs), progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment. For non-target lesions (NTLs), PD was defined as unequivocal progression of existing NTLs. Participants were censored at the date of last post-baseline (BL) tumor assessment where non-progression was documented. If no post-BL tumor assessment was available, the participant was censored at date of randomization.
Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
PFS
Lasso di tempo: Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
The median time, in weeks, from randomization to PFS event. Participants were censored at the date of last post-BL tumor assessment where non-progression was documented. If no post-BL tumor assessment was available, the participant was censored at date of randomization. PFS was estimated using Kaplan-Meier methodology.
Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants Who Died
Lasso di tempo: Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
Overall survival (OS) was defined as the time from randomization to the date of death, due to any cause. Participants were censored at final analysis at the date the participant was last known to be alive.
Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
OS
Lasso di tempo: Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
The median time, in months, from randomization to OS event. Participants were censored at final analysis at the date the participant was last known to be alive.
Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST V 1.0
Lasso di tempo: Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
BOR was defined as the best response recorded from randomization until disease progression/recurrence or death, taking as reference for PD the smallest measurement (nadir) recorded since treatment started. Assignment of PR of CR required confirmation of tumor measurement changes by repeat assessments performed no less than 4 weeks after criteria for response was first met. For TLs, CR was defined as the disappearance of all TLs; and PR was defined as at least a 30% decrease in the SLD of the TLs, taking BL SLD as reference. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% CI for one sample binomial was calculated using the Pearson-Clopper method.
Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
Percentage of Participants With Disease Control According to RECIST V 1.0
Lasso di tempo: Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis, 12 months after the last participant's 1st visit
Disease control was defined as a BOR of CR, PR, or SD according to RECIST V 1.0 for at least 4 weeks at any time during randomized treatment or disease stabilization, after study entry. Participants without a post-BL assessment of response were considered as having no disease control. The 95% CI for the one sample binomial was calculated using the Pearson-Clopper method.
Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis, 12 months after the last participant's 1st visit

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hoffmann-La Roche

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2008

Completamento primario (Effettivo)

1 gennaio 2010

Completamento dello studio (Effettivo)

1 gennaio 2010

Date di iscrizione allo studio

Primo inviato

18 settembre 2007

Primo inviato che soddisfa i criteri di controllo qualità

18 settembre 2007

Primo Inserito (Stima)

19 settembre 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

11 novembre 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 novembre 2014

Ultimo verificato

1 novembre 2014

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • BO20571

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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