A Trial of ALIMTA (Pemetrexed) Plus Irinotecan in Patients Who Have Been Previously Treated For Metastatic Colorectal Cancer.

This is a non-randomized study in patients who have received prior 5-FU therapy for colorectal cancer. The objective of this trial is to establish a maximum tolerated dose of ALIMTA and irinotecan given in combination as well as to assess the safety and efficacy of this combination for patients with locally advanced or metastatic colorectal cancer. ALIMTA and irinotecan will be given every 21 days.

Inclusion Criteria:

• Histologic or cytologic diagnosis of locally or metastatic colorectal cancer
• Prior therapy with 5-FU for metastatic cancer
• Adequate bone marrow, liver and kidney function

Exclusion Criteria:

• Pregnancy
• Breast feeding
• Inability to interrupt aspirin therapy
• Brain metastasis
• Patients who have been treated previously with ALIMTA or irinotecan