Pemetrexed and Gemcitabine Every 14 Days Versus Every 21 Days in Advanced Non Small Cell Lung Cancer

Study Overview
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Brief Summary
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This study is designed to evaluate Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8 every 21 days (Arm A) and Pemetrexed and Gemcitabine Day 1 every 14 days (Arm B) in patients with NSCLC. Each agent and sequence has well demonstrated antitumor activity respectively in patients with locally advanced or metastatic NSCLC. Therefore, it is reasonable to investigate the most optimal schedule for this combination, and which combination is associated with the most anti-tumor activity in the phase II arena.

Official Title
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A Phase II Study of ALIMTA® (Pemetrexed) and GEMZAR® (Gemcitabine) Every 14 Days Versus Pemetrexed and Gemcitabine Every 21 Days in Advanced Non-Small Cell Lung Cancer

Conditions
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Non-Small-Cell 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: histologic or cytologic diagnosis of NSCLC Stage IIIB or IV no prior systemic chemotherapy for advanced Non-Small Cell Lung Cancer Prior radiotherapy must be completed at least 4 weeks before study enrollment. Exclusion Criteria: estimated life expectancy of 12 weeks a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease documented brain metastases unless the patient has completed successful local therapy for central nervous system metastases and has been off of corticosteroids for at least 2 weeks before enrollment significant weight loss (that is, > 10%) over the previous 6 weeks before study entry.

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, intravenous (IV), every 21 days x 6 cycles B: 500 mg/m2, intravenous (IV), every 14 days x 9 cycles<br>* Other names: Alimta;Drug: Gemcitabine<br>* A: 1250 mg/m2, intravenous (IV) days 1 and 8, every 21 days x 6 cycles B: 1500 mg/m2, intravenous (IV), every 14 days x 9 cycles<br>* Other names: Gemzar;|
| Experimental: B<br> | Drug: Pemetrexed<br>* A: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles B: 500 mg/m2, intravenous (IV), every 14 days x 9 cycles<br>* Other names: Alimta;Drug: Gemcitabine<br>* A: 1250 mg/m2, intravenous (IV) days 1 and 8, every 21 days x 6 cycles B: 1500 mg/m2, intravenous (IV), every 14 days x 9 cycles<br>* Other names: Gemzar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Overall Tumor 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. | baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | baseline to measured progressive disease | baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up | 
| Time to Progressive Disease | Time to progressive disease not analyzed because trial was stopped early due to low enrollment. | baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up | 
| Duration of Response | Duration of response was not analyzed because the trial was stopped early due to low enrollment. | baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up | 
| Time to Treatment Failure | Time to treatment failure was not analyzed because the trial was stopped early due to low enrollment. | baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up | 
| Overall Survival | Survival time is defined as the time from date of randomization to death due to any cause. | baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up |