A Study of the Combination of Pemetrexed and Irinotecan Every Two Weeks in Metastatic Colorectal Cancer

Open Multicenter Phase II Study in Second-Line Metastatic Colorectal Cancer Patients: Combination of ALIMTA and Irinotecan Administered Every Two-Weeks

A non-randomized phase II study to determine the efficacy and safety of the combination of Pemetrexed and Irinotecan every two weeks in metastatic colorectal cancer patients.

Inclusion Criteria:

• Diagnosis of metastatic colorectal adenocarcinoma that is not amenable to curative therapy.
• Patient must have at least one unidimensionally measurable lesion.
• Prior radiation therapy to less than 25% of bone marrow. Radiation must be completed at least 4 weeks prior to study enrollment.
• Performance status 0 to 2
• Patient must have received 1 prior course of chemotherapy (Folfox regimen) for metastatic disease

Exclusion Criteria:

• Treatment with any drug within the last 30 days that has not received regulatory approval.
• Serious systemic disorder (cardiac or pulmonary disease, active infection)
• Documented brain metastases not amenable to surgery or unstable after radiation
• Inability or unwillingness to take folic acid or Vitamin B12 supplementation.
• Presence of fluid retention that can not be controlled by drainage.