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
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    Assessment of response will be assessed according to RECIST v1.1 criteria


Secondary Outcome Measures:
  • 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


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Korean South West Oncology Group
ClinicalTrials.gov Identifier: NCT01497041     History of Changes
Other Study ID Numbers: KSWOG 2010-3
Study First Received: December 14, 2011
Last Updated: December 19, 2011
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 01, 2014