ALIMTA (Pemetrexed) in Patients With Locally Advanced or Metastatic Cancer

A Phase 1 Trial of ALIMTA (Pemetrexed) in Patients With Locally Advanced or Metastatic Cancer

This is a non-randomized, phase 1, study with the primary objective of determining the toxicities and establishing the maximum tolerated dose of ALIMTA when administered as a 10 minute infusion every 21 days with folic acid or multi-vitamin supplementation therapy in lightly or heavily pre-treated patients with locally advanced or metastatic cancer.

Inclusion Criteria:

• Histologic or cytologic diagnosis of metastatic or locally advanced cancer
• Prior chemotherapy is allowed
• Adequate bone marrow, liver and kidney function

Exclusion Criteria:

• Prior treatment with ALIMTA
• Brain metastasis
• Pregnancy or breast feeding