Dosage Schedule Study of Pemetrexed Monochemotherapy for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Pemetrexed Monochemotherapy in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer. A Pilot Study to Define the Best Dosing Schedule for a Planned Phase II Randomized Trial

Patients affected by non-small cell lung cancer (NSCLC) will be treated in pemetrexed monochemotherapy regimen for a maximum of 8 cycles. Pemetrexed is an enhancer of some biomolecules involved in the gemcitabine mechanism of action. Purpose of the trial is to monitor the blood values of these biomolecules at different time intervals, to optimize the synergism between pemetrexed and gemcitabine.

Inclusion Criteria

• Histologically or cytologically proven IIIB and IV NSCLC.
• No symptomatic uncontrolled brain metastasis
• Not suitable for platinum containing regimens if chemo-naive
• Performance status less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) Scale.
• Creatinine Clearance (CrCl) greater than or equal to 45 milliliters per min (mL/min)

Exclusion Criteria

• Prior radiation to greater than 25% of bone marrow
• Inability to interrupt Aspirin at doses of greater than 1.3 grams/day or non-steroidal anti-inflammatory agents for a 5-day period.
• Presence of clinically relevant third-space fluid collections not controllable.
• Significant cardiac disease