Status:
UNKNOWN
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
Lead Sponsor:
Korean South West Oncology Group
Conditions:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01497041
Start Date
February 1 2011
End Date
December 1 2013
Last Update
December 22 2011
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Soonchunhyang University Cheonan Hospital
Cheonan, South Korea
2
Chungbuk National University Hospital
Cheongju-si, South Korea
3
Chungnam National University Hospital
Daejeon, South Korea
4
The Catholic University of Korea Daejeon ST. Mary's Hospital
Daejeon, South Korea