Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly Non-Small Cell Lung Cancer (NSCLC) Patients

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of advanced NSCLC.
• Stage III with pleural effusion and stage IV.
• Patients are 70 years old.
• Patients with 1 > ECOG PS =1.
• 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; Leukocyte count >= 4000x10(6)/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.

Exclusion Criteria:

• Prior systemic chemotherapy for advanced disease.
• Patients with symptomatic brain metastases.
• No measurable bone metastases or malignant pleural effusion as only measurable lesion.
• 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 to study drugs.
• 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.