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
18 Years
75 Years
Both
Non-small Cell Lung Cancer
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The primary objective of this study is to evaluate the 1-year treatment failure rate of two sequential chemotherapy regimens.
Outcome Time Frame:
2003~2009
Safety Issue:
No
Principal Investigator
Chih-Hsin Yang, M.D.,Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Oncology , National Taiwan University Hospital
Authority:
Taiwan: Department of Health
Study ID:
920303
NCT ID:
NCT00173888
Start Date:
July 2003
Completion Date:
November 2012
Related Keywords:
- Non-Small Cell Lung Cancer
- Combination, Chemotherapy,non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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