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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00441922

Enrollment

166

Registered

2007-03-01

Start date

2003-01-31

Completion date

2008-01-31

Last updated

2008-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

Keywords

Cancer, Elderly, Chemotherapy, Docetaxel, Vinorelbine

Brief summary

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

Detailed 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.

Interventions

DRUGDocetaxel

Docetaxel at the dose of 38 mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles

DRUGVinorelbine

Vinorelbine at the dose of 25 mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Overall survival between the two treatment arms	1 year

Secondary

Measure	Time frame
Time to disease progression	1 year
Toxicity profile	During the time of chemotherapy

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026