Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Advanced Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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This purpose of this study is to evaluate the role of gemcitabine and docetaxel, a well tolerated chemotherapy regimen in the treatment of advanced non-small cell lung cancer (NSCLC), in combination with a novel agent cetuximab.

Detailed Description
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Upon determination of eligibility all patients will receive: Docetaxel + Gemcitabine + Cetuximab

Official Title
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A Phase II Trial of First-Line Therapy With Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Stage III or IV Non-Small Cell Lung Cancer

Conditions
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Lung Cancer

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be included in the study, you must meet the following criteria: 18 years of age or older Non-small cell lung cancer confirmed by biopsy Unresectable stage III or IV disease Measurable disease Must not have received any prior chemotherapy for lung cancer Able to perform activities of daily living without considerable assistance Adequate bone marrow, kidney, and liver function Signed informed consent Exclusion Criteria: You cannot participate in the study if any of the following apply to you: History of serious heart disease within six months prior to study entry Prior treatment with agents that target the EGFR pathway History of any other uncontrolled or significant disease Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d). | Drug: Gemcitabine<br>* 1000mg/m2 30min IV, Day 1 & 8<br>* Other names: Gemzar;Drug: Docetaxel<br>* 30mg/m2, 30min IV, day 1 & 8<br>* Other names: Taxotere;Drug: Cetuximab<br>* 100mg/m2 IV, Cycle 1 Day 1, 250mg/m2 IV day 8 & 15, all subsequent cycles 250mg/m2 IV day 1, 8, & 15<br>* Other names: Erbitux;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Clinical Response Rate | Overall response rate was defined as the proportion of treated patients whose best response was a complete or partial response after completing at least two courses of treatment. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) | Progression free survival was defined as the interval between the start date of treatment and the date of occurrence of progressive disase or death from any cause. | 18 months | 
| Response Duration | The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Cancer