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Phase II Trial of Dose-dense Paclitaxel and Cisplatin as Neo-adjuvant Chemotherapy for Operable Stage II and IIA NSCLC

30. april 2012 oppdatert av: Central European Cooperative Oncology Group

Phase II Trial of Dose-dense Paclitaxel and Cisplatin as Neo-adjuvant Chemotherapy for Operable Stage II and IIA Non-Small Cell Lung Cancer

A single arm, open-label phase II is appropriate to evaluate the efficacy and safety of dose - dense combination of paclitaxel with cisplatin supported by pegfilgrastim for neo-adjuvant chemotherapy in this patient population.

Studieoversikt

Status

Avsluttet

Forhold

Ikke-småcellet lungekreft

Intervensjon / Behandling

Legemiddel: Paclitaxel, Cisplatin, Pegfilgrastim

Detaljert beskrivelse

This is an open-label, single-arm Phase II study of dose-dense regimen with paclitaxel and cisplatin supported by pegfilgrastim as neo-adjuvant chemotherapy in patients with operable stage II, IIA NSCLC.

Paclitaxel will be administered via intravenous infusion over approximately 3 hours at dose of 175mg/m2 on Day 1 of each 14-day cycle. Cisplatin 75mg/m2 will be given via intravenous infusion on day 1 (after paclitaxel) according to institutional guidelines.

Pegfilgrastim (Neulasta) fixed dose of 6mg (0.6mL of a 10mg/mL solution) as a single subcutaneous injection on Day 2 of each study cycle.

All drugs will be given in 2-weekly cycle. Three cycles of pre-operative chemotherapy are planned.

Studietype

Intervensjonell

Registrering (Faktiske)

Fase

Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Polen
- - Warszawa, Polen, 02-781
    - M. Sklodowska-Curie Memorial Dep. Of Lung and Thoracic Tumours,
  - Warszawa, Polen
    - Klinika Chirurgii Instytutu Gruzlicy i Chorob Pluc
Ungarn
- - Mosdos, Ungarn
    - Somogy Country Pulmo and Cardio Hospital,
  - Szombathely, Ungarn
    - Markusovszky Hospital
Østerrike
- - Vienna, Østerrike, 1090
    - AKH, Universitätsklinik für Innere Medizin 1

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

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

histologic or cytologic diagnosis of NSCLC
Presence of clinical Stage IIA,IIB or IIA disease
tumor amenable to curative surgical resection
Patients with clinically measurable lesions will be enrolled in this study.
No prior tumor therapy
Performance status of 0-1 on ECOG Scale
Patients compliance and geographic proximity that allow adequate follow-up.
Medical fitness of patient, including respiratory function, adequate for radical NSCLC surgery.

Exclusion Criteria:

Presence of clinical Stage IIIA disease, according to the revision by Mountain CF of American Joint Committee on Cancer.
Treatment within the last 30 days with any investigational drug.
Cocurrent administration of any other tumor therapy, including radiotherapy, cytotoxic chemotherapy, immunotherapy, molecular target therapy.
Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
pregnancy/breast feeding
Serious concomitant disorders that would compromise the safety of the patient or compromise the patients ability to complete the study, at the discretion of the investigator.
poorly controlled diabetes mellitus
Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
History of significant neurological or mental disorder, including seizures or dementia.

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: Ikke-randomisert
Intervensjonsmodell: Enkeltgruppeoppdrag
Masking: Ingen (Open Label)

Hva måler studien?

Primære resultatmål

Resultatmål
the evaluation of the clinical response rate of neo-adjuvant chemotherapy with dose-dense therapy of paclitaxel and cisplatin(PC) with peg-filgrastim in patients with operable NSCLC

Sekundære resultatmål

Resultatmål
- total overlevelse
>To evaluate the safety of neo-adjuvant chemotherapy with PC
- to characterize the toxicity of PC, include febrile neutropenia.
- to evaluate peri- and post-operative mortality
> to determine the pathological complete response rate
> to determine the complete tumor resection rate
> to evaluate proportion of cycle 2 and all cycles chemotherapy given with planned dose-on-time and proportion of patients receiving planned dose-on-time in cycle 2 and over all cycles.
> To evaluate the following time-to-event efficacy variables:
- disease free survival
> to evaluate Quality of life (EORTC QLQ-C30 and QLQ-LC13)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Central European Cooperative Oncology Group

Etterforskere

Hovedetterforsker: Maciej Krzakowski, MD, M.Sklodowska-Curie Memorial, Dep of Lung and Thoracic Tumours, Warsaw

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. juni 2005

Datoer for studieregistrering

Først innsendt

14. februar 2006

Først innsendt som oppfylte QC-kriteriene