A Multicenter Randomized Phase III Study of the Docetaxel and Gemcitabine Combination Versus Monotherapy With Gemcitabine as First-line Treatment in Elderly Patients With Advanced Non-Small-Cell Lung Cancer (NSCLC)
70 Years
85 Years
Both
Non-small-cell Lung Cancer
Trial Information
A Multicenter Randomized Phase III Study of the Docetaxel and Gemcitabine Combination Versus Monotherapy With Gemcitabine as First-line Treatment in Elderly Patients With Advanced Non-Small-Cell Lung Cancer (NSCLC)
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, there are only few randomized trials evaluating a two drug
combination specifically addressed to elderly patients. The role of comprehensive geriatric
assessment in treatment efficacy and tolerance is an area of investigation
Inclusion Criteria:
- 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 Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival between the two treatment arms
Outcome Time Frame:
Probability of 1 year survival (%)
Safety Issue:
No
Principal Investigator
Lampros Vamvakas, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital of Crete, Dep of Medical Oncology
Authority:
Greece: National Organization of Medicines
Study ID:
CT/06.11
NCT ID:
NCT00442026
Start Date:
December 2006
Completion Date:
May 2010
Related Keywords:
- Non-Small-Cell Lung Cancer
- Cancer
- NSCLC
- Elderly
- Chemotherapy
- Docetaxel
- Gemcitabine
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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