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
NCT ID: NCT01497041
Last Updated: 2011-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
35 participants
INTERVENTIONAL
2011-02-28
2013-12-31
Brief Summary
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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
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Docetaxel
Docetaxel (diluted in 250 ml of 5% dextrose solution, over 60 minutes) 35 mg/m2 IV (D1, D8) every 3 weeks
Oxaliplatin
Oxaliplatin (diluted in 500 ml of 5% dextrose solution, over 120 minutes) 60 mg/m2 IV D1 every 3 weeks
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Korean South West Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Sang Byung Bae, M.D.
Role: PRINCIPAL_INVESTIGATOR
Soonchunhyang University Hospital
Locations
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Soonchunhyang University Cheonan Hospital
Cheonan, , South Korea
Chungbuk National University Hospital
Cheongju-si, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
The Catholic University of Korea Daejeon ST. Mary's Hospital
Daejeon, , South Korea
Chonbuk National University Hospital
Jeonju, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Sang Byung Bae, M.D.
Role: primary
Ki Hyeong Lee
Role: primary
Hwan Jung Yun
Role: primary
Suk Young Park
Role: primary
Eun-Kee Song
Role: primary
Other Identifiers
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KSWOG 2010-3
Identifier Type: -
Identifier Source: org_study_id