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

This study has been completed.
Sponsor:
Information provided by:
West Japan Thoracic Oncology Group
ClinicalTrials.gov Identifier:
NCT00148291
First received: September 6, 2005
Last updated: January 5, 2006
Last verified: September 2005

September 6, 2005
January 5, 2006
June 1999
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Complete list of historical versions of study NCT00148291 on ClinicalTrials.gov Archive Site
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Phase III Study of Docetaxel Vs Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer
Phase III Study of Docetaxel Vs Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer

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.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
Drug: Patients were randomized to receive either docetaxel 60 mg/m2 on day 1 or vinorelbine 25 mg/m2 on days 1and 8, repeated every 21 days over four cycles.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
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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.-

Both
70 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00148291
WJTOG9904
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West Japan Thoracic Oncology Group
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Principal Investigator: Shinzoh Kudoh, MD West Japan Thoracic Oncology Group
West Japan Thoracic Oncology Group
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP