Non-small Cell Lung Cancer
Conditions
Keywords
Combination, Chemotherapy,non-small cell lung cancer
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 cisplatin followed by weekly docetaxel。
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 carcinogens have been implicated. Despite intensive treatment over the past several decades, the 5-year lung-cancer survival rate remains a dismal 8-14%. Chemotherapy is the primary therapy to patients with stage IIIB/IV disease, and most investigators believe that treatment with a combination of two agents is the best first-line treatment for stage IV NSCLC. In the late 1970s and 1980s, studies were conducted using combinations of agents. Outcomes were improved and these agents were eventually incorporated into clinical practice. Weekly docetaxel is being studied in combination with other commonly used NSCLC chemotherapeutic agents including carboplatin, navelbine, and gemcitabine. These combinations are being studied in both first- and second-line settings. Second line chemotherapy with docetaxel may affect survival (TAX 318, 1 year survival 37% vs. 11%). However, the optimal sequence of chemotherapy was rarely explored. Weekly docetaxel may offer better tolerability vs. 3-weekly schedule when combining docetaxel to cisplatin. Based upon these studied, we choose weekly docetaxel in combination with cisplatin as our regimen. We expected the regimen would be effective and well tolerated.
Interventions
docetaxel 36mg/m2 IF 30 mins on day 1,8,15 cisplatin 75mg/m2 IF 2 hrs on day 15
gemcitabine 1000mg/m2 IF 30mins on D 1,8,15, cisplatin 75mg/m2 IF 2 hrs on day 15
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to evaluate the 1-year treatment failure rate of two sequential chemotherapy regimens. | 2003~2009 |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the response rate for each regimen, the toxicity of each arm, and the duration of response | 2003~2009 |
Countries
Taiwan
Outcome results
None listed