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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Korean South West Oncology Group.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Korean South West Oncology Group
ClinicalTrials.gov Identifier:
NCT01497041
First received: December 14, 2011
Last updated: December 19, 2011
Last verified: December 2011

December 14, 2011
December 19, 2011
February 2011
December 2013   (final data collection date for primary outcome measure)
Response rate [ Time Frame: 2years ] [ Designated as safety issue: No ]
Assessment of response will be assessed according to RECIST v1.1 criteria
Same as current
Complete list of historical versions of study NCT01497041 on ClinicalTrials.gov Archive Site
  • Overall survival [ Time Frame: 2years ] [ Designated as safety issue: No ]
    Overall survival will be calculated by Kaplan-Meier method
  • Progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Progression free survival will be calculated by Kaplan-Meier method
  • Number of Participants with Adverse Events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Assessment of toxicity will be assessed according to CTCAE version 4.0
  • Quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Quality of life will be assessed according to EORTC QLQ-C30, LC13
Same as current
Not Provided
Not Provided
 
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
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
  1. 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

  2. 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
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Squamous
  • Carcinoma, Large Cell
  • Drug: Docetaxel
    Docetaxel (diluted in 250 ml of 5% dextrose solution, over 60 minutes) 35 mg/m2 IV (D1, D8) every 3 weeks
  • Drug: Oxaliplatin
    Oxaliplatin (diluted in 500 ml of 5% dextrose solution, over 120 minutes) 60 mg/m2 IV D1 every 3 weeks
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
35
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients who were diagnosed as non-adenocarcinoma, non-small cell carcinoma of lung histologically or cytologically
  2. Patients must be ≥ 18 years old of age
  3. ECOG performance status ≤ 1
  4. Estimated life expectancy of more than 3 months
  5. Treatment with only one prior chemotherapy
  6. At least one lesion that can be measured by imaging (CT/MRI) according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
  7. 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)
  8. Adequate kidney function (serum creatinine < 1.5 x upper limit of normal [ULN])
  9. Adequate liver function (serum total bilirubin < 1.5xULN; serum transaminases levels < 2.5xUNL)
  10. Provision of fully informed consent prior to any study specific procedures

Exclusion Criteria:

  1. Pregnant or breastfeeding women and women of childbearing potential not employing adequate contraception
  2. Patients who received prior chemotherapy including paclitaxel or docetaxel
  3. 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)
  4. Patients with defect of central nervous system (CNS) or any psychiatric disorders and CNS metastases
  5. 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
  6. Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy
Both
18 Years and older
No
Contact: Sang Byung Bae +82-41-570-3667 baesan@schmc.ac.kr
Contact: Hwan Jung Yun +82-42-280-7157 hjyun@cnu.ac.kr
Korea, Republic of
 
NCT01497041
KSWOG 2010-3
No
Korean South West Oncology Group
Korean South West Oncology Group
Not Provided
Principal Investigator: Sang Byung Bae, M.D. Soonchunhyang University Cheonan Hospital
Korean South West Oncology Group
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP