Status:
COMPLETED
Docetaxel Plus Cisplatin Followed by Gemcitabine Versus Gemcitabine Plus Cisplatin Followed by Docetaxel for Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the 1-year treatment failure rate of two sequential chemotherapy regimens: weekly docetaxel plus cisplatin followed by gemcitabine; and gemcitabine plus cispla...
Detailed Description
Lung cancer is the leading cause of cancer death in men and women worldwide. Shifting trends in the incidence of lung cancer closely follow the patterns of cigarette smoking, although other carcinogen...
Eligibility Criteria
Inclusion
- Histologic or cytologic diagnosis of stage IIIB/IV NSCLC, no prior chemotherapy
- Age \> 18 years and \< 75 years
- WHO PS: 0,1
- Unidimensional or bi-dimensional measurable disease
- Neutrophils \> 1.5 109/l, Platelets \> 100 109/l, Hemoglobin \> 10g/dl, Total bilirubin \< 1.5 UNL, AST (SGOT) and ALT (SGPT) \< 2.5 UNL, Alkaline phosphatases \< 5 UNL; except in presence of only bone metastasis and in the absence of any liver disorders
- Creatinine \< 1 UNL, and creatinine clearance should be \> 60 ml/min.
- Life expectancy \> 12 weeks
Exclusion
- Pregnant, or lactating patients
- Known clinical brain or leptomeningeal involvement
- Pre-existing motor or sensory neurotoxicity of a severity \> grade 1 by NCIC-CTG criteria
- CHF, angina or arrhythmias
- History of significant neurological or psychiatric disorders
- Active uncontrolled infection
- Contraindication for the use of corticosteroids
- Concurrent treatment with other experimental drugs within 30 days prior to study entry
- Concurrent treatment with any other anti-cancer therapy
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00173888
Start Date
July 1 2003
End Date
November 1 2012
Last Update
December 6 2012
Active Locations (1)
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1
Department of Oncology, National Taiwan University Hospital
Taipei, Taiwan