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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by Korean South West Oncology Group.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01497041
First Posted: December 22, 2011
Last Update Posted: December 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Korean South West Oncology Group
  Purpose
  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

Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Carcinoma, Large Cell Drug: Docetaxel Drug: Oxaliplatin Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Korean South West Oncology Group:

Primary Outcome Measures:
  • Response rate [ Time Frame: 2years ]
    Assessment of response will be assessed according to RECIST v1.1 criteria


Secondary Outcome Measures:
  • Overall survival [ Time Frame: 2years ]
    Overall survival will be calculated by Kaplan-Meier method

  • Progression free survival [ Time Frame: 2 years ]
    Progression free survival will be calculated by Kaplan-Meier method

  • Number of Participants with Adverse Events [ Time Frame: 2 years ]
    Assessment of toxicity will be assessed according to CTCAE version 4.0

  • Quality of life [ Time Frame: 2 years ]
    Quality of life will be assessed according to EORTC QLQ-C30, LC13


Estimated Enrollment: 35
Study Start Date: February 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01497041


Contacts
Contact: Sang Byung Bae +82-41-570-3667 baesan@schmc.ac.kr
Contact: Hwan Jung Yun +82-42-280-7157 hjyun@cnu.ac.kr

Locations
Korea, Republic of
Soonchunhyang University Cheonan Hospital Recruiting
Cheonan, Korea, Republic of
Contact: Sang Byung Bae, M.D.    +82-41-570-3667    baesan@schmc.ac.kr   
Principal Investigator: Sang Byung Bae, M.D.         
Sub-Investigator: Han Jo Kim, M.D.         
Sub-Investigator: Kyu Taek Lee, M.D.         
Chungbuk National University Hospital Recruiting
Cheongju, Korea, Republic of
Contact: Ki Hyeong Lee    +82-43-269-6015    kihlee@chungbuk.ac.kr   
Sub-Investigator: Hye Suk Han         
Principal Investigator: Ki Hyeong Lee         
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of
Contact: Hwan Jung Yun    +82-42-280-7157    hjyun@cnuh.co.kr   
Principal Investigator: Hwan Jung Yun         
Sub-Investigator: Sam Yong Kim         
Sub-Investigator: Hyo Jin Lee         
The Catholic University of Korea Daejeon ST. Mary's Hospital Recruiting
Daejeon, Korea, Republic of
Contact: Suk Young Park    +82-42-220-9832    sypark1011@hotmail.com   
Principal Investigator: Suk Young Park         
Sub-Investigator: Young Joon Yang         
Sub-Investigator: Ji Chan Park         
Chonbuk National University Hospital Recruiting
Jeonju, Korea, Republic of
Contact: Eun-Kee Song    +82-63-254-1609    eksong@jbnu.ac.kr   
Principal Investigator: Eun-Kee Song         
Sub-Investigator: Chang-Yeol Yim         
Sub-Investigator: Na-Ri Lee         
Sponsors and Collaborators
Korean South West Oncology Group
Investigators
Principal Investigator: Sang Byung Bae, M.D. Soonchunhyang University Cheonan Hospital
  More Information

Responsible Party: Korean South West Oncology Group
ClinicalTrials.gov Identifier: NCT01497041     History of Changes
Other Study ID Numbers: KSWOG 2010-3
First Submitted: December 14, 2011
First Posted: December 22, 2011
Last Update Posted: December 22, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Carcinoma, Large Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Squamous Cell
Docetaxel
Oxaliplatin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action