Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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This study is designed to study the role of an active and well-tolerated non-platinum agent, gemcitabine, in a combination regimen with pemetrexed in the first-line treatment of advanced NSCLC. This study will serve to define the role of next generation agents in a new combination regimen in the treatment of advanced NSCLC. This combination regimen may ultimately be important in further expanding treatment options for patients while improving survival, quality of life, and symptom control compared with platinum-based combination regimens - and with acceptable toxicity.

Detailed Description
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Upon determination of eligibility, patients will be receive: Pemetrexed + Gemcitabine

Official Title
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Phase II Study of First-Line Therapy With Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: Pemetrexed
* Drug: Gemcitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be included in this study, you must meet the following criteria: Histologically confirmed non-small cell bronchogenic carcinoma Newly diagnosed or recurrent unresectable stage III or stage IV disease No mixed tumors with small cell anaplastic elements Measurable disease Must not have received any prior antineoplastic chemotherapy for lung cancer Age > 18 years Able to perform activities of daily living with little or no assistance Adequate bone marrow, liver and kidney Understand the nature of this study and give written informed consent. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Female patients who are pregnant or are lactating History of serious cardiovascular disease within the previous six months Serious active infection at the time of treatment Other serious underlying medical condition 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.

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>Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy. | Drug: Pemetrexed<br>* 500mg/m2 IV over 10 min, Day 1, prior to gemcitabine<br>* Other names: Alimta;Drug: Gemcitabine<br>* 1500mg/m2, 30min IV<br>* Other names: Gemzar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate | Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival (PFS) | PFS was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause. | 18 months | 
| Overall Survival (OS) | OS was measured from the date of study entry until the date of death. | 18 months |