Randomized Trial of Docetaxel and Gemcitabine Versus Gemcitabine in Elderly Patients With NSCLC

A Multicenter Randomized Phase III Study of the Docetaxel and Gemcitabine Combination Versus Monotherapy With Gemcitabine as First-line Treatment in Elderly Patients With Advanced Non-Small-Cell Lung Cancer (NSCLC)

This trial will compare the efficacy of the docetaxel and gemcitabine combination versus monotherapy with gemcitabine as first-line treatment in elderly patients with advanced NSCLC

Docetaxel and gemcitabine 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. However, there are only few randomized trials evaluating a two drug combination specifically addressed to elderly patients. 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
• Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated.
• Absence or irradiated and stable central nervous system metastatic disease
• Life expectancy of more than 3 months
• Age ≥ 70 years.
• Performance status (WHO) < 3
• Patients "non-frail" according to comprehensive geriatric assessment
• Adequate bone marrow function (Absolute neutrophil count > 1000/mm^3, Platelet count > 100000/mm^3, Hemoglobin > 9gr/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 < 2mg/dl).
• Adequate cardiac function (LVEF > 50%).
• 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 presence of a reliable care giver
• Other concurrent investigational agents.