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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Docetaxel, Cisplatin
* Drug: Gemcitabine, Cisplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Docetaxel, Cisplatin<br>* docetaxel 36mg/m2 IF 30 mins on day 1,8,15 cisplatin 75mg/m2 IF 2 hrs on day 15<br>|
| Active Comparator: B<br> | Drug: Gemcitabine, Cisplatin<br>* gemcitabine 1000mg/m2 IF 30mins on D 1,8,15, cisplatin 75mg/m2 IF 2 hrs on day 15<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the response rate for each regimen, the toxicity of each arm, and the duration of response |  | 2003 2009 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Combination, Chemotherapy,non-small cell lung cancer