A Comparison of Two Doses of Pemetrexed in Patients Who Have Lung Cancer

Study Overview
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Brief Summary
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The purposes of this study are to determine: the safety of pemetrexed and any side effects that might be associated with it how much pemetrexed should be given to patients. It is possible that information collected during this study will be analyzed by the Sponsor in the future to evaluate pemetrexed for other possible uses or for other medical or scientific purposes other than those currently proposed. Although pemetrexed has been shown to be effective in some patients with non-small-cell lung cancer, pemetrexed might not have beneficial effects for all patients.

Official Title
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A Randomized Phase 3 Study of Two Doses of Alimta in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed a Prior Platinum-Containing Chemotherapy

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: pemetrexed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of locally advanced or metastatic (Stage III or IV at entry) non-small cell lung cancer (NSCLC) that is not amenable to curative therapy. Patients must have been previously treated with one platinum-containing chemotherapy regimen for locally advanced or metastatic disease. Patients are also eligible if they have received one platinum-based chemotherapy regimen as neoadjuvant or adjuvant chemotherapy, but must have received an additional chemotherapy regimen upon recurrence. No more than two prior systemic anti-cancer therapies will be allowed. Prior radiation therapy is allowed to less than 25% of the bone marrow. Prior radiation to the whole pelvis is not allowed. Prior radiotherapy must be completed at least 2 weeks before study enrollment, and the patient must have recovered from the acute toxic effects of the treatment prior to study enrollment. Exclusion Criteria: Pregnancy. Breast-feeding. Second primary malignancy that is clinically detectable at the time of consideration for study enrollment. Inability to interrupt aspirin, or other nonsteroidal anti-inflammatory agents for a 5-day period. Inability or unwillingness to take folic acid or vitamin B12 supplementation.

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>* A: 500 mg/m2, IV, q 21 days until disease progression B: 900 mg/m2, IV, q 21 days until disease progression<br>|
| Experimental: B<br> | Drug: pemetrexed<br>* A: 500 mg/m2, IV, q 21 days until disease progression B: 900 mg/m2, IV, q 21 days until disease progression<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 | 
| Tumor response rate |  | baseline to measured progressive disease | 
| Adverse events |  | every cycle |