Pemetrexed and Cisplatin Treatment Before Surgery in Non Small Cell Lung Cancer

Study Overview
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Brief Summary
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To determine the response to this regimen for therapy prior surgery in patients with locally advanced disease or metastatic disease.

Official Title
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Alimta (Pemetrexed) and Cisplatin Treatment as Neoadjuvant Therapy in Non Small Cell Lung Cancer

Conditions
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Non-Small-Cell Lung Cancer

Intervention / Treatment
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* Drug: pemetrexed
* Drug: cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of non-small-cell carcinoma of the lung Patients with locally advanced disease or metastatic disease, candidates to surgery after evaluation by oncologist and thoracic surgeon Tumour with possibility of curative surgery At least one uni-dimensionally measurable lesion Adequate pulmonary function to perform the planned surgical resection Exclusion Criteria: Active infection (at the investigator's discretion) Pregnancy or breast-feeding Serious concomitant illness at the investigator's discretion Previous diagnosis of malignant disease They have received treatment during the last 30 days with a drug, other than the study drug, that has not received regulatory approval for any indication at the time of their entry in the study

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: pemetrexed<br>* 500 mg/m2, intravenous (IV), every 21 days x 3 cycles<br>* Other names: Alimta;Drug: cisplatin<br>* 75 mg/m2, intravenous (IV), every 21 days x 3 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Response | Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment. | every 21 day cycle (3 cycles) and 3-4 weeks after last cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologic Remissions After Surgery | The status of the pathological response was evaluated on the basis of the original results of the histopathological examination of the tumour samples resected. A complete pathological response was defined as the absence of any viable tumour cell in the tumour samples obtained for histological examination. | surgical tumor resection (3-4 weeks after completing three 21-day cycles of therapy) | 
| Relapse-free Survival | Results for this outcome measure were not analyzed because the trial stopped early due to low enrollment. | Every 21 day cycle (3 cycles) and then every 3 months for the first 2 years, every 6 months until 5 years have elapsed and annually thereafter |