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

Study Overview

• Status: Unknown
• Conditions: Carcinoma, Non-Small-Cell Lung; Carcinoma, Large Cell; Carcinoma, Squamous
• Intervention / Treatment: Drug: Docetaxel; Drug: Oxaliplatin

• Study Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Cheonan, Korea, Republic of
    • Recruiting
    • Soonchunhyang University Cheonan Hospital
    • Contact: Sang Byung Bae, M.D.; Phone Number: +82-41-570-3667; Email: 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.
  • Cheongju, Korea, Republic of
    • Recruiting
    • Chungbuk National University Hospital
    • Principal Investigator: Ki Hyeong Lee
    • Contact: Ki Hyeong Lee; Phone Number: +82-43-269-6015; Email: kihlee@chungbuk.ac.kr
    • Sub-Investigator: Hye Suk Han
  • Daejeon, Korea, Republic of
    • Recruiting
    • Chungnam national university hospital
    • Contact: Hwan Jung Yun; Phone Number: +82-42-280-7157; Email: hjyun@cnuh.co.kr
    • Sub-Investigator: Sam Yong Kim
    • Sub-Investigator: Hyo Jin Lee
  • Daejeon, Korea, Republic of
    • Recruiting
    • The Catholic University of Korea Daejeon St. Mary's Hospital
    • Contact: Suk Young Park; Phone Number: +82-42-220-9832; Email: sypark1011@hotmail.com
    • Principal Investigator: Suk Young Park
    • Sub-Investigator: Young Joon Yang
    • Sub-Investigator: Ji Chan Park
  • Jeonju, Korea, Republic of
    • Recruiting
    • Chonbuk National University Hospital
    • Contact: Eun-Kee Song; Phone Number: +82-63-254-1609; Email: eksong@jbnu.ac.kr
    • Principal Investigator: Eun-kee Song
    • Sub-Investigator: Chang-Yeol Yim
    • Sub-Investigator: Na-Ri Lee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response rate	Assessment of response will be assessed according to RECIST v1.1 criteria	2years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival will be calculated by Kaplan-Meier method	2years
Progression free survival	Progression free survival will be calculated by Kaplan-Meier method	2 years
Number of Participants with Adverse Events	Assessment of toxicity will be assessed according to CTCAE version 4.0	2 years
Quality of life	Quality of life will be assessed according to EORTC QLQ-C30, LC13	2 years

Collaborators and Investigators

• Sponsor: Korean South West Oncology Group
• Investigators: Principal Investigator: Sang Byung Bae, M.D., Soonchunhyang University Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: December 14, 2011
• First Submitted That Met QC Criteria: December 19, 2011
• First Posted (Estimate): December 22, 2011

Study Record Updates

• Last Update Posted (Estimate): December 22, 2011
• Last Update Submitted That Met QC Criteria: December 19, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Neoplasms, Squamous Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma; Carcinoma, Squamous Cell; Carcinoma, Large Cell; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Oxaliplatin
• Other Study ID Numbers: KSWOG 2010-3