Trial of Docetaxel Versus Vinorelbine as 1st Line Treatment in Elderly Patients With Non-Small-Cell Lung Cancer (NSCLC)

Study Overview
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Brief Summary
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This trial will compare the efficacy of docetaxel versus vinorelbine as first-line treatment in elderly patients with advanced NSCLC.

Detailed Description
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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 of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation.

Official Title
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A Multicenter Randomized Phase II Study of Docetaxel Versus Vinorelbine as First-Line Treatment in Elderly Patients With Advanced Non-Small-Cell Lung Cancer (NSCLC)

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Vinorelbine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 absence or irradiated and stable central nervous system metastatic disease. No presence of a reliable care giver Other concurrent investigational agents

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>D | Drug: Docetaxel<br>* Docetaxel at the dose of 38 mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles<br>* Other names: Taxotere;|
| Experimental: 2<br>V | Drug: Vinorelbine<br>* Vinorelbine at the dose of 25 mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles<br>* Other names: Navelbine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival between the two treatment arms |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to disease progression |  | 1 year | 
| Toxicity profile |  | During the time of chemotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Elderly, Chemotherapy, Docetaxel, Vinorelbine