Docetaxel Plus Cisplatin Followed by Gemcitabine Versus Gemcitabine Plus Cisplatin Followed by Docetaxel for Non-Small Cell Lung Cancer (NSCLC)
|Non-small Cell Lung Cancer||Drug: Docetaxel, Cisplatin Drug: Gemcitabine, Cisplatin||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Study of Weekly Docetaxel Plus Cisplatin Followed by Gemcitabine Versus Gemcitabine Plus Cisplatin Followed by Weekly Docetaxel in the Treatment of Advanced Non-small Cell Lung Cancer|
- The primary objective of this study is to evaluate the 1-year treatment failure rate of two sequential chemotherapy regimens. [ Time Frame: 2003~2009 ]
- To evaluate the response rate for each regimen, the toxicity of each arm, and the duration of response [ Time Frame: 2003~2009 ]
|Study Start Date:||July 2003|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Drug: Docetaxel, Cisplatin
docetaxel 36mg/m2 IF 30 mins on day 1,8,15 cisplatin 75mg/m2 IF 2 hrs on day 15
|Active Comparator: B||
Drug: Gemcitabine, Cisplatin
gemcitabine 1000mg/m2 IF 30mins on D 1,8,15, cisplatin 75mg/m2 IF 2 hrs on day 15
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00173888
|Department of Oncology, National Taiwan University Hospital|
|Principal Investigator:||Chih-Hsin Yang, M.D.,Ph.D.||Department of Oncology , National Taiwan University Hospital|
|Study Chair:||Ann-Lii Cheng, M.D.,Ph.D.||Department of Oncology , National Taiwan University Hospital|