Status:
COMPLETED
Trial of Docetaxel Versus Vinorelbine as 1st Line Treatment in Elderly Patients With Non-Small-Cell Lung Cancer (NSCLC)
Lead Sponsor:
Hellenic Oncology Research Group
Collaborating Sponsors:
University Hospital of Crete
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
65-80 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2008
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT00441922
Start Date
January 1 2003
End Date
January 1 2008
Last Update
October 29 2008
Active Locations (10)
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1
University General Hospital of Alexandroupolis, Department of Medical Oncology
Alexandroupoli, Greece
2
401 Military Hospital of Athens
Athens, Greece
3
Air Forces Military Hospital of Athens
Athens, Greece
4
IASO General Hospital of Athens, 1st Department of Medical Oncology
Athens, Greece