Status:
COMPLETED
Phase III Study of Docetaxel Vs Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer
Lead Sponsor:
West Japan Thoracic Oncology Group
Conditions:
Lung Cancer
Eligibility:
All Genders
70+ years
Phase:
PHASE3
Brief 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 s...
Eligibility Criteria
Inclusion
- 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
- 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.-
Key Trial Info
Start Date :
June 1 1999
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00148291
Start Date
June 1 1999
Last Update
January 6 2006
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.