Phase II Study of Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer Patients With ECOG PS 2
- Histologically or cytologically confirmed diagnosis of advanced NSCLC.
- Stage III with pleural effusion and stage IV.
- Patients with ECOG PS 2.
- Patients must have at least one measurable lesion, no previously irradiated.
- Life expectancy of at least 12 weeks.
- Adequate organ function according to the following criteria:
- Bone marrow: ANC => 2.0x10(9)cells/L; Platelet count => 100x10(9)cells/L;
Hemoglobin => 10 g/dL.
- Liver function: Bilirubin <= 1.5 X ULN; Alkaline phosphatase <= 5 x ULN; AST and
ALT <= 1.5 x ULN.
- Renal function:serum creatinine <= 2mg/dL.
- Prior systemic chemotherapy for advanced disease.
- Prior radiotherapy for NSCLC.
- Patients with symptomatic brain metastases.
- No measurable bone metastases or malignant pleural effusion as only measurable
- History of prior malignancies, except curatively treated in situ carcinoma of the
cervix or other cancer curatively treated and with no evidence of disease for at
least five years.
- History of hypersensitivity reaction study drugs.
- Pregnant or lactating women (women of childbearing potential must use adequate
- Concurrent treatment with other experimental drugs.
- Current peripheral neuropathy NCI grade 2.
- Participation in clinical trials within 30 days of study entry.
- Major surgery, open biopsy or traumatic lesion 28 days before to study start.