Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer

Phase II Study of First-Line Therapy With Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer

This study is designed to study the role of an active and well-tolerated non-platinum agent, gemcitabine, in a combination regimen with pemetrexed in the first-line treatment of advanced NSCLC. This study will serve to define the role of next generation agents in a new combination regimen in the treatment of advanced NSCLC. This combination regimen may ultimately be important in further expanding treatment options for patients while improving survival, quality of life, and symptom control compared with platinum-based combination regimens - and with acceptable toxicity.

Upon determination of eligibility, patients will be receive:

• Pemetrexed + Gemcitabine

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

• Histologically confirmed non-small cell bronchogenic carcinoma
• Newly diagnosed or recurrent unresectable stage III or stage IV disease
• No mixed tumors with small cell anaplastic elements
• Measurable disease
• Must not have received any prior antineoplastic chemotherapy for lung cancer
• Age > 18 years
• Able to perform activities of daily living with little or no assistance
• Adequate bone marrow, liver and kidney
• Understand the nature of this study and give written informed consent.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

• Female patients who are pregnant or are lactating
• History of serious cardiovascular disease within the previous six months
• Serious active infection at the time of treatment
• Other serious underlying medical condition

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.