Trial of Docetaxel Versus Vinorelbine as 1st Line Treatment in Elderly Patients With Non-Small-Cell Lung Cancer (NSCLC)

A Multicenter Randomized Phase II Study of Docetaxel Versus Vinorelbine as First-Line Treatment in Elderly Patients With Advanced Non-Small-Cell Lung Cancer (NSCLC)

This trial will compare the efficacy of docetaxel versus vinorelbine as first-line treatment in elderly patients with advanced NSCLC.

Docetaxel and vinorelbine are well known active agents in the treatment of NSCLC. The standard treatment of elderly patients with advanced NSCLC is monotherapy with a third generation agent. The role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation.

Inclusion Criteria:

• Histologically- or cytologically- confirmed Non-Small-Cell Lung Cancer
• Stage IIIB/IV
• No prior chemotherapy
• Existence of two-dimensional measurable disease. The measurable disease should not have been irradiated
• Life expectancy of more than 3 months
• Age ≥ 65 years
• Performance status (WHO) ≤ 3
• Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, Hemoglobin > 9 gr/mm^3)
• Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal), and renal function (creatinine < 2 mg/dl)
• Informed consent

Exclusion Criteria:

• Psychiatric illness or social situation that would preclude study compliance.
• Other concurrent uncontrolled illness
• Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
• No absence or irradiated and stable central nervous system metastatic disease.
• No presence of a reliable care giver
• Other concurrent investigational agents