A Randomized Phase 3 Trial of Pemetrexed and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

Study Overview
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Brief Summary
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This study is a randomized Phase 3 study comparing pemetrexed and cisplatin combination to gemcitabine and cisplatin for the treatment of Non Small Cell Lung Cancer (NCSLC). Gemcitabine plus cisplatin is currently the standard of care for NSCLC. It is thought that pemetrexed plus cisplatin may be as effective and may have fewer side effects than the standard of care.

Official Title
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A Randomized Phase 3 Trial of ALIMTA and Cisplatin Versus GEMZAR and Cisplatin in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Conditions
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Non Small Cell Lung Carcinoma

Intervention / Treatment
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* Drug: pemetrexed
* Drug: gemcitabine
* Drug: cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of NSCLC Stage IIIB not amenable to curative treatment or Stage IV. No prior chemotherapy for lung cancer. Patients must have at least one uni-dimensionally measurable lesion. Prior radiation therapy to less than 25% of bone marrow, whole pelvis not allowed. Radiation must be completed at least 4 weeks prior to study enrollment. Exclusion Criteria: Treatment with any drug within the last 30 days that has not received regulatory approval. Serious cardiac condition. Serious medical disorder in addition to NSCLC that would make it difficult for the patient to complete the study. Inability or unwillingness to take folic acid or Vitamin B12 supplementation. Presence of fluid retention that cannot be controlled by drainage.

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: pemetrexed<br>* 500 mg/m2, IV q 21 days x 6 cycles<br>* Other names: Alimta;Drug: cisplatin<br>* 75 mg/m2, IV, q 21 days x 6 cycles<br>|
| Active Comparator: B<br> | Drug: gemcitabine<br>* 1250 mg/m2, IV, day 1 and 8 q 21 days x 6 cycles<br>* Other names: Gemzar;Drug: cisplatin<br>* 75 mg/m2, IV, q 21 days x 6 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | baseline to date of death from any cause | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | baseline to measured progressive disease | 
| Time to progressive disease |  | baseline to measured progressive disease | 
| Duration of response |  | time of response to progressive disease | 
| Time to treatment failure |  | baseline to stopping treatment |