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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous, Carcinoma, Large Cell

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Oxaliplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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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 |