A Phase II Study of Docetaxel Combined With Cisplatin as the First Line Chemotherapy in Patients With Metastatic Non-small Cell Lung Cancer
- Histologically or cytologically proven non-small cell lung carcinoma
- Stage IV metastatic non-small cell lung carcinoma or stage III with malignant pleural
- Patient should not be eligible for customization chemotherapy (if available at
- Having at least one measurable lesion
- Patient has life expectancy of 12 weeks or greater.
- Age > 18 years.
- No prior systemic treatment for metastatic lung cancer. Adjuvant treatment given
more than 1 year ago is acceptable.
- WHO performance status 0-2 (See Appendix III )
- Adequate organ function:
- Hematology: Neutrophils > 2 x 10 9 /L, platelets > 100 x 10 9 /L
- Hepatic function: Total bilirubin < 1.25 times the upper normal limits, ASAT
(SGOT) < 2 times the upper normal limits
- Renal function: Creatinine < 1.5 mg/dL; if value is higher than upper normal
limit but less than 2 mg/dL, the creatinine clearance should be > 60min/ml.
- Able to comply with scheduled follow-up and with management of toxicity
- Signed informed consent from patient or legal representative
- Negative urine pregnancy test (if indicated)
- Pregnant or lactating women or women of childbearing potential using inadequate
- Uncontrolled brain metastatic disease. (CNS disease that is stable > 4 weeks after
radiotherapy in lieu of steroids reduction is eligible).
- Symptomatic peripheral neuropathy > grade 1 according to the NCI Common Toxicity
Criteria Version 3
- Other serious illness or medical condition:
- Unstable cardiac disease requiring treatment
- History of significant neurologic or psychiatric disorders including psychotic
disorders, dementia or seizures
- Active uncontrolled infection
- Concurrent treatment with other experimental drugs. Participation in another
clinical trial with any investigational drug within 30 days prior to study screening
- Concurrent treatment with any other anti-cancer therapy
- Contraindication of steroid drug administration
- Past (up to 5 years) or concurrent history of other neoplasm except curatively
treated non- melanoma skin cancer or in situ carcinoma of the cervix