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

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

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.

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.