Docetaxel Plus Cisplatin Followed by Gemcitabine Versus Gemcitabine Plus Cisplatin Followed by Docetaxel for Non-Small Cell Lung Cancer (NSCLC)
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|ClinicalTrials.gov Identifier: NCT00173888|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : December 6, 2012
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: Docetaxel, Cisplatin Drug: Gemcitabine, Cisplatin||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2003|
|Primary Completion Date :||November 2012|
|Study Completion Date :||November 2012|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|