Docetaxel Plus Cisplatin Followed by Gemcitabine Versus Gemcitabine Plus Cisplatin Followed by Docetaxel for Non-Small Cell Lung Cancer (NSCLC)

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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 cisplatin followed by weekly docetaxel。

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Cisplatin; Docetaxel; Gemcitabine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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