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Docetaxel Versus Intercalated Erlotinib-docetaxel in Patients With Relapsed EGFR Wild Type, ALK Negative Non Squamous Cell Carcinoma

26. april 2019 opdateret af: The Netherlands Cancer Institute

A Randomized Phase III Study of Docetaxel Versus Intercalated Erlotinib Docetaxel Combination Therapy in Patients With Relapsed EGFR (Epidermal Growth Factor Receptor) Wild Type, ALK(Anaplastic Lymphoma Kinase) Negative Non Squamous Cell Carcinoma. (NVALT 18 Study)

The objective of this study is to investigate the effect of docetaxel monotherapy and the combination of docetaxel intercalated erlotinib in patients with relapsed EGFR wild type, ALK negative non squamous cell carcinoma.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The aim of this study is to investigate the effect of docetaxel monotherapy and the combination of docetaxel intercalated erlotinib in patients with relapsed EGFR wild type, ALK negative non squamous cell carcinoma.

As pemetrexed is standard first line treatment, the combination of erlotinib docetaxel in non-squamous NSCLC should be investigated as second line treatment. Also the question has to be answered whether the combination outperforms monotherapy treatments.

After stratification for ECOG-performance status (0-1), response to prior treatment (CR, PR, SD versus PD), treatment free interval after platinum based therapy (<6 months versus >6 months) and maintenance, patients will be centrally randomized to receive either docetaxel (arm A) or docetaxel plus erlotinib (arm B).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

45

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Holland
      • Apeldoorn, Holland
        • Gelre Ziekenhuis
      • Breda, Holland
        • Amphia Hospital
      • Den Bosch, Holland
        • Jeroen Bosch Hospital
      • Den Haag, Holland, 2545 CH
        • Haga
      • Dordrecht, Holland
        • Albert Schweitzer Ziekenhuis
      • Ede, Holland
        • Ziekenhuis Gelderse Vallei
      • Eindhoven, Holland, 5631 BM
        • Maxima Medisch Centrum
      • Groningen, Holland
        • Martini Ziekenhuis
      • Hoofddorp, Holland, 2130 AT
        • Spaarne Gasthuis
      • Leeuwarden, Holland, 8934 AD
        • MCL
      • Maastricht, Holland
        • Maastricht University Medical Center
      • Roermond, Holland
        • Laurentius Hospital
      • Rotterdam, Holland
        • Erasmus MC
      • Rotterdam, Holland, 3045 PM
        • St. Fransicus Gasthuis
      • Rotterdam, Holland, 3083 AN
        • Ikazia
      • Utrecht, Holland
        • St. Antonius Ziekenhuis
      • Venlo, Holland
        • VieCuri Medisch Centrum voor Noord-Limburg
      • the Hague, Holland
        • Medical Center Haaglanden
    • Noord-Holland
      • Amsterdam, Noord-Holland, Holland, 1081HV
        • VUmc 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

Alle

Beskrivelse

Inclusion Criteria:

  1. Histologically or cytologically confirmed EGFR wild type, ALK negative, non-squamous cell carcinoma, locally advanced and metastatic disease stage IIIB and IV. Evidence of disease progression after one cytotoxic treatment platinum containing regimen. Immunotherapy pretreatment is allowed
  2. Complete recovery from prior chemotherapy side effects to < Grade 2.
  3. At least one unidimensionally measurable lesion meeting RECIST criteria.
  4. ECOG PS 0-1.
  5. Age ≥ 18 years.

  6. Adequate organ function, including:

    • Adequate bone marrow reserve: ANC > 1.5 x 109/L, platelets ≥ 100 x 109/L.
    • Hepatic: bilirubin ≤1.5 x ULN (upper limit normal), AP, ALT, AST ≤ 1.5 x ULN. AP, ALT, and AST ≤5 x ULN is acceptable if the liver has tumor involvement.
    • Renal: calculated creatinine clearance ≥ 40 ml/min based on the Cockcroft-Gault formula.
  7. Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate. Female patients with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
  8. Signed informed consent.
  9. Patient compliance and geographical proximity that allow adequate follow up.
  10. Patients who have undergone cranial irradiation for brain metastases more than 4 weeks before inclusion in our protocol, provided that they are clinically fit to undergo second line treatment

Exclusion Criteria:

  1. Pregnant or lactating women.
  2. Patients with medical risks because of non-malignant disease as well as those with active uncontrolled infection.
  3. Documented brain metastases unless the patient has completed local therapy for central nervous system metastases at least 4 weeks before enrollment and has been off corticosteroids for at least two weeks before enrollment. Prophylactic irradiation at least 4 weeks prior to enrollment is accepted.
  4. Maintenance treatment with erlotinib or other TKI (Tyrosine Kinase Inhibitor), or docetaxel. Maintenance treatment with pemetrexed is allowed. Previous treatment with an EGFR-TKI or docetaxel within 6 months prior to enrollment.
  5. Inability or unwillingness to take dexamethasone.
  6. Concomitant treatment with any other experimental drug under investigation.
  7. Patients experiencing disease progression within 2 months after the start of platinum based chemotherapy

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Docetaxel
Docetaxel 75mg/m2 every 21 days until disease progression or toxicity related
Medicin: Docetaxel
75mg/m2
Andre navne:
  • Taxotere
Aktiv komparator: Docetaxel plus erlotinib
Docetaxel 75mg/m2 on Day 1 plus erlotinib 150mg/day days 2-16, every 21 days, until disease progression, or toxicity related.
Medicin: Docetaxel
75mg/m2
Andre navne:
  • Taxotere
Medicin: Erlotinib
150mg/day
Andre navne:
  • Tarceva

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
progression free survival
Tidsramme: from the date of randomization to the first date of progression of disease or of death from any cause up to 24 months after last treatment administration
from the date of randomization to the first date of progression of disease or of death from any cause up to 24 months after last treatment administration

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
quantitative and qualitative adverse events
Tidsramme: from the date of randomization until resolution or stabilization of the event and up to 30 days after the last study medication/treatment
Adverse events will be graded according to NCI Common Toxicity Criteria version 4.03
from the date of randomization until resolution or stabilization of the event and up to 30 days after the last study medication/treatment
response rates
Tidsramme: Every six weeks from date of randomization until the date of first documented progression or date of death from any cause up to 24 months after last treatment administration
Every six weeks from date of randomization until the date of first documented progression or date of death from any cause up to 24 months after last treatment administration
duration of response
Tidsramme: from the date of the first objective status assessment of a complete or partial response to the first date of progression of disease or death from any cause up to 24 months after last treatment administration
from the date of the first objective status assessment of a complete or partial response to the first date of progression of disease or death from any cause up to 24 months after last treatment administration
overall survival
Tidsramme: from the date of randomization to the date of death from any cause up to 24 months after last treatment administration
Evaluation of overall survival (OS)
from the date of randomization to the date of death from any cause up to 24 months after last treatment administration

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Erlotinib dose level variance in blood
Tidsramme: Every six weeks from randomisation up until last treatment administration (up until 48 weeks)
Therefore in patients on erlotinib every 6 weeks through dose levels in blood will be determined
Every six weeks from randomisation up until last treatment administration (up until 48 weeks)

Samarbejdspartnere og efterforskere

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

Sponsor

The Netherlands Cancer Institute

Samarbejdspartnere

Dutch Society of Physicians for Pulmonology and Tuberculosis

Efterforskere

  • Ledende efterforsker: Joachim G Aerts, MD PhD, Dutch Society of Physicians for Pulmonology and Tuberculosis

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)

14. oktober 2016

Primær færdiggørelse (Faktiske)

1. april 2019

Studieafslutning (Faktiske)

1. april 2019

Datoer for studieregistrering

Først indsendt

12. april 2016

Først indsendt, der opfyldte QC-kriterier

12. maj 2016

Først opslået (Skøn)

17. maj 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. april 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. april 2019

Sidst verificeret

1. april 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NVALT 18

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

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Kliniske forsøg med Docetaxel

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Macedonia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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