Overview

Phase III Study of Docetaxel Vs Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer

Status:
Completed

Trial end date:
1969-12-31

Target enrollment:
0

Participant gender:
All

Summary

Vinorelbine is currently the standard treatment for elderly patients with advanced non-small cell lung cancer (NSCLC). Docetaxel has also shown promising results against elderly patients in phase II studies. We conducted a randomized phase III trial to evaluate whether docetaxel provided better overall survival than vinorelbine in elderly patients with advanced NSCLC.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

West Japan Thoracic Oncology Group

Treatments:

Docetaxel
Vinblastine
Vinorelbine

Criteria

Inclusion Criteria:

Chemotherapy- and radiotherapy-naïve patients with histologically or cytologically
diagnosis of stage IIIB or IV NSCLC and who were ≧ 70 years old with measurable or
assessable disease were eligible for this trial. They had to have a life expectancy of at
least 3 months. Additional entry criteria were as follows: (a) a performance status (PS) 0
to 2 on the Eastern Cooperative Oncology Group scale; (b) adequate function of bone marrow
(leukocyte count ≧ 4,000/μL, absolute neutrophil count ≧ 2,000/μL, hemoglobin concentration
≧ 9.5 g/dL, platelet count ≧ 100,000/μL), kidney (serum creatinine ≦ 1.2 mg/dL), liver
(total bilirubin ≦ 1.5 times the institutional upper limits of normal, transaminase of AST
and ALT ≦ 2.5 times the institutional upper limits of normal).

Exclusion Criteria:

Patients with symptomatic brain metastasis or apparent dementia were ineligible. Patients
with active concomitant malignancy, massive pleural effusion or ascites, active infection,
severe heart disease, grade 2 or higher ECG abnormality, uncontrolled diabetes mellitus,
ileus, pulmonary fibrosis, diarrhea, and a bleeding tendency were excluded.-