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A Phase II Clinical Trial of Docetaxel, Oxaliplatin Combination Chemotherapy in Patients With Stage IIIB/IV Non-adenocarcinoma, Non-small Cell Lung Cancer (NSCLC) as Second-line Treatment

19. desember 2011 oppdatert av: Korean South West Oncology Group

Goals
The primary goal of this phase II trial is to:
evaluate the response rate of combination chemotherapy with docetaxel and oxaliplatin in patients with stage IIIB/IV non-adenocarcinoma, non-small cell lung cancer (NSCLC) as second-line treatment
Secondary goals are to:
evaluate the treatment-related toxicities of this combination, investigate progression-free survival (PFS) and overall survival (OS) in this population
Design The proposed clinical trial is an open label, non-comparative, multicenter phase II trial according to the two stage testing design by Simon two-stage testing procedure

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Forventet)

Fase

Fase 2

Kontakter og plasseringer

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

Studiesteder

Korea, Republikken
- - Cheonan, Korea, Republikken
    - Rekruttering
    - Soonchunhyang University Cheonan Hospital
    - Ta kontakt med:
      
      Sang Byung Bae, M.D.
      
      Telefonnummer: +82-41-570-3667
      
      E-post: baesan@schmc.ac.kr
    - Hovedetterforsker:
      
      Sang Byung Bae, M.D.
    - Underetterforsker:
      
      Han Jo Kim, M.D.
    - Underetterforsker:
      
      Kyu Taek Lee, M.D.
  - Cheongju, Korea, Republikken
    - Rekruttering
    - Chungbuk National University Hospital
    - Hovedetterforsker:
      
      Ki Hyeong Lee
    - Ta kontakt med:
      
      Ki Hyeong Lee
      
      Telefonnummer: +82-43-269-6015
      
      E-post: kihlee@chungbuk.ac.kr
    - Underetterforsker:
      
      Hye Suk Han
  - Daejeon, Korea, Republikken
    - Rekruttering
    - Chungnam National University Hospital
    - Ta kontakt med:
      
      Hwan Jung Yun
      
      Telefonnummer: +82-42-280-7157
      
      E-post: hjyun@cnuh.co.kr
    - Underetterforsker:
      
      Sam Yong Kim
    - Underetterforsker:
      
      Hyo Jin Lee
  - Daejeon, Korea, Republikken
    - Rekruttering
    - The Catholic University of Korea Daejeon St. Mary's Hospital
    - Ta kontakt med:
      
      Suk Young Park
      
      Telefonnummer: +82-42-220-9832
      
      E-post: sypark1011@hotmail.com
    - Hovedetterforsker:
      
      Suk Young Park
    - Underetterforsker:
      
      Young Joon Yang
    - Underetterforsker:
      
      Ji Chan Park
  - Jeonju, Korea, Republikken
    - Rekruttering
    - Chonbuk National University Hospital
    - Ta kontakt med:
      
      Eun-Kee Song
      
      Telefonnummer: +82-63-254-1609
      
      E-post: eksong@jbnu.ac.kr
    - Hovedetterforsker:
      
      Eun-kee Song
    - Underetterforsker:
      
      Chang-Yeol Yim
    - Underetterforsker:
      
      Na-Ri Lee

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

Patients who were diagnosed as non-adenocarcinoma, non-small cell carcinoma of lung histologically or cytologically
Patients must be ≥ 18 years old of age
ECOG performance status ≤ 1
Estimated life expectancy of more than 3 months
Treatment with only one prior chemotherapy
At least one lesion that can be measured by imaging (CT/MRI) according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Adequate bone marrow function (absolute neutrophil count [ANC] ≥ 1,500/µL, hemoglobin ≥ 9.0 g/dL [correction by transfusion is acceptable], and platelets ≥ 100,000/µL)
Adequate kidney function (serum creatinine < 1.5 x upper limit of normal [ULN])
Adequate liver function (serum total bilirubin < 1.5xULN; serum transaminases levels < 2.5xUNL)
Provision of fully informed consent prior to any study specific procedures

Exclusion Criteria:

Pregnant or breastfeeding women and women of childbearing potential not employing adequate contraception
Patients who received prior chemotherapy including paclitaxel or docetaxel
Patients with second primary cancer (except, adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥5 years)
Patients with defect of central nervous system (CNS) or any psychiatric disorders and CNS metastases
Other serious illness or medical conditions A. Clinically significant cardiac disease (uncontrolled congestive heart disease despite treatment [NYHA class III or IV], symptomatic coronary artery disease, unstable angina or myocardial infarction, conduction abnormality like grade 2 AV block, serious arrhythmia needed for medication, uncontrolled hypertension) within 6 months prior to study entry B. Liver cirrhosis (≥ Child-Pugh class B) C. History of significant neurologic or psychiatric disorders including dementia or seizures D. Active uncontrolled infection E. Other serious underlying medical conditions which could impair the ability of the patient to participate in the study
Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy

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: N/A
Intervensjonsmodell: Enkeltgruppeoppdrag
Masking: Ingen (Open Label)

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Response rate Tidsramme: 2years	Assessment of response will be assessed according to RECIST v1.1 criteria	2years

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Overall survival Tidsramme: 2years	Overall survival will be calculated by Kaplan-Meier method	2years
Progression free survival Tidsramme: 2 years	Progression free survival will be calculated by Kaplan-Meier method	2 years
Number of Participants with Adverse Events Tidsramme: 2 years	Assessment of toxicity will be assessed according to CTCAE version 4.0	2 years
Quality of life Tidsramme: 2 years	Quality of life will be assessed according to EORTC QLQ-C30, LC13	2 years

Samarbeidspartnere og etterforskere

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

Sponsor

Korean South West Oncology Group

Etterforskere

Hovedetterforsker: Sang Byung Bae, M.D., Soonchunhyang University Hospital

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 2011

Primær fullføring (Forventet)

1. desember 2013

Studiet fullført (Forventet)