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

• Status: Terminated
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

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

Criteria

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.