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Dose-Dense Induction/Neoadjuvant Chemotherapy in Locally Advanced Non-Small Cell Lung Cancer

5. juni 2014 opdateret af: Duke University

Dose-Dense Induction/Neoadjuvant Chemotherapy in the Treatment of Patients With Locally Advanced Non-Small Cell Lung Cancer With Additional Genomic Analyses to Identify Signatures Predictive of Chemotherapy Response.

Dose-dense chemotherapy is a chemotherapy treatment plan in which drugs are given with less time between treatments than in standard chemotherapy. The two chemotherapy drugs used in this study, docetaxel and cisplatin, are approved for the treatment of lung cancer when given every 21 days. This study is exploring the response to chemotherapy when these drugs are given every 14 days. In addition, genetic tests will be performed on pre-treatment specimens to identify signatures that may predict chemotherapy sensitivity or resistance.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

All patients will receive induction chemotherapy with cisplatin and docetaxel. Pegfilgrastim will be administered approximately 24 hours following the end of the day 1 chemotherapy infusion. Cycles will be repeated every 2 weeks for 3 cycles. Patients deemed to be resectable will undergo surgical resection followed by postoperative thoracic radiotherapy. Patients deemed inoperable will additionally receive concurrent chemoradiotherapy. Response, using radiographic and/or pathologic means, will identify two cohorts; responders and nonresponders.Gene expression profiling will then be performed on pre-treatment specimens to identify signatures that predict for chemotherapy sensitivity or resistance.

The target enrollment is 45 patients.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

13

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke University 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:

  • Patients with documented stage III NSCLC (IIIA or IIIB, without malignant pleural/pericardial effusion) are eligible for enrollment if they are considered appropriate for treatment with chemotherapy, radiation, or surgery;
  • IIIA: T1-3 N2 M0, T3 N1 M0
  • IIIB: T4 N0-2 M0, T 1-4 N3 M0
  • Measurable or evaluable disease
  • Previously untreated with chemotherapy or radiotherapy for lung cancer;
  • No brain metastases;
  • No prior XRT
  • Performance status 0-2
  • ≥18 years of age
  • Informed Consent
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  • Platelets ≥ 100 x 109/L
  • Bilirubin ≤ 1.5 x upper limit of normal for the institution (ULN)
  • SGOT and SGPT ≤ 2.5 x ULN for the institution
  • Creatinine ≤ 1.6 mg/dL
  • Hemoglobin ≥ 8.0 g/dL
  • Peripheral neuropathy ≤ grade 1

Exclusion Criteria:

  • Known sensitivity to E. coli derived products (e.g. Filgrastim, HUMULIN® insulin, L-asparaginase, HUMATROPE® Growth Hormone, INTRON® A);
  • Use of IV systemic antibiotics within 72 hours prior to chemotherapy;
  • Known HIV infection
  • Lithium or cytokines within 2 weeks prior of entry
  • Additional concurrent investigational drugs
  • History of myelodysplastic syndrome
  • Pregnant, nursing or having unprotected sex
  • Not available for follow-up assessment
  • Unable to comply with protocol procedures
  • Illnesses that may compromise ability to give informed consent.
  • Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80.

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: Induction Chemotherapy
Cisplatin 75mg/m2 IV days 1, 15, 29; Docetaxel 75mg/m2 IV days 1, 15, 29; and Pegfilgrastim 6mg SC day 2, 16, 30
Medicin: Docetaxel
Andre navne:
  • Taxotere
Medicin: cisplatin
Andre navne:
  • Platinol
Medicin: Pegfilgrastim
Andre navne:
  • Neulasta

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Induction Response
Tidsramme: Between 2 and 3 weeks after induction
Response will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Response is defined as the number patients with a Complete Response (CR), disappearance of all target lesions, or a Partial Response (PR), at least a 30% decrease in the sum of the longest diameter (LD) of target lesions.
Between 2 and 3 weeks after induction
Differential Gene Expression Between Responsive and Resistant Tumor Treated With Dose-dense Therapy
Tidsramme: at the end of the study, estimated 2.5 years
at the end of the study, estimated 2.5 years

Sekundære resultatmål

Resultatmål
Tidsramme
Number of Grade III/IV Hematologic Adverse Events
Tidsramme: During induction chemotherapy, approximately 6 weeks
During induction chemotherapy, approximately 6 weeks
Number of Grade III/IV Non-hematologic Adverse Events
Tidsramme: During induction chemotherapy, approximately 6 weeks
During induction chemotherapy, approximately 6 weeks
Number of Patients Who Were Able to Maintain Hemoglobin Between 11-13 g/dL During Induction
Tidsramme: During induction, approximately 6 weeks
During induction, approximately 6 weeks
Overall Survival
Tidsramme: Approximately 10 years
Approximately 10 years

Samarbejdspartnere og efterforskere

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

Sponsor

Duke University

Samarbejdspartnere

Sanofi

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

1. maj 2006

Primær færdiggørelse (Faktiske)

1. oktober 2009

Studieafslutning (Faktiske)

1. januar 2010

Datoer for studieregistrering

Først indsendt

29. maj 2014

Først indsendt, der opfyldte QC-kriterier

2. juni 2014

Først opslået (Skøn)

5. juni 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. juli 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juni 2014

Sidst verificeret

1. juni 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Pro00004682

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 .

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Betingelser

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Sponsor / samarbejdspartnere

Placeringer

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