Randomized Trial of Docetaxel and Gemcitabine Versus Gemcitabine in Elderly Patients With NSCLC

Study Overview
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Brief Summary
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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
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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

Official Title
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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)

Conditions
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Non-small-cell Lung Cancer

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Gemcitabine
* Drug: Gemcitabine


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 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.

Ages Eligible for Study
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Minimum Age: 70 Years
Maximum Age: 85 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>DG | Drug: Docetaxel<br>* Docetaxel at the dose of 30mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles<br>* Other names: Taxotere;Drug: Gemcitabine<br>* Gemcitabine at the dose of 900mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles<br>* Other names: Gemzar;|
| Experimental: 2<br>G | Drug: Gemcitabine<br>* Gemcitabine at the dose of 1200mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles<br>* Other names: Gemzar;|

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 |  | Probability of 1 year survival (%) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) | 
| Time to disease progression |  | 1 year | 
| Quality of life assessment |  | Assessment every two cycles | 
| Toxicity profile |  | Assessment every two cycles | 

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