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)

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00442026

Enrollment

106

Registered

2007-03-01

Start date

2006-12-31

Completion date

2010-05-31

Last updated

2012-06-27

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, NSCLC, Elderly, Chemotherapy, Docetaxel, Gemcitabine

Brief 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

Detailed description

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

Interventions

DRUGDocetaxel

Docetaxel at the dose of 30mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles

DRUGGemcitabine

Gemcitabine at the dose of 900mg/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

70 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Overall survival between the two treatment arms	Probability of 1 year survival (%)

Secondary

Measure	Time frame
Overall response rate	Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Time to disease progression	1 year
Quality of life assessment	Assessment every two cycles
Toxicity profile	Assessment every two cycles

Countries

Greece

Outcome results

None listed

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