Status:
TERMINATED
Randomized Trial of Docetaxel and Gemcitabine Versus Gemcitabine in Elderly Patients With NSCLC
Lead Sponsor:
Hellenic Oncology Research Group
Collaborating Sponsors:
University Hospital of Crete
Conditions:
Non-small-cell Lung Cancer
Eligibility:
All Genders
70-85 years
Phase:
PHASE3
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, ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT00442026
Start Date
December 1 2006
End Date
May 1 2010
Last Update
June 27 2012
Active Locations (9)
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1
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, Greece
2
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece
3
401 Military Hospital, Medical Oncology Unit
Athens, Greece
4
Air Forces Military Hospital, Dep of Medical Oncology
Athens, Greece