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

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Oncology Research Group
• Collaborator: University Hospital of Crete
• Treatments: Docetaxel; Vinblastine; Vinorelbine

Criteria

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