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

Phase 2

• Conditions: Carcinoma, Non-Small-Cell Lung; Carcinoma, Squamous; Carcinoma, Large Cell

• Registration Number: NCT01497041
• Lead Sponsor: Korean South West Oncology Group

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Status Verified: 2011-12
• Study First Submitted: 2011-12-14
• Study First Submitted QC: 2011-12-19
• Last Update Submitted: 2011-12-19
• Study First Posted: 2011-12-22
• Last Update Posted: 2011-12-22
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Response rate	2years	Assessment of response will be assessed according to RECIST v1.1 criteria

Secondary Outcome Measures

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

Trial Locations

Locations (5)

The Catholic University of Korea Daejeon ST. Mary's Hospital; 🇰🇷 Daejeon, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of

Soonchunhyang University Cheonan Hospital; 🇰🇷 Cheonan, Korea, Republic of

Chonbuk National University Hospital; 🇰🇷 Jeonju, Korea, Republic of

Chungbuk National University Hospital; 🇰🇷 Cheongju, Korea, Republic of