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

Hellenic Oncology Research Group

Status and phase

Completed

Phase 3

Conditions

Non Small Cell Lung Cancer

Treatments

Drug: Vinorelbine

Drug: Docetaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT00441922

CT/03.07

Details and patient eligibility

About

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

Full description

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.

Enrollment

166 estimated patients

Sex

All

Ages

65 to 80 years old

Volunteers

No Healthy Volunteers

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