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

National Taiwan University

Status and phase

Completed

Phase 2

Conditions

Non-small Cell Lung Cancer

Treatments

Drug: Docetaxel, Cisplatin

Drug: Gemcitabine, Cisplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00173888

920303

Details and patient eligibility

About

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。

Full 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.

Enrollment

15 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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