A Randomized Phase 2 Trial of ALIMTA Plus a Comparator Versus Leucovorin Modulated Fluorouracil Plus a Comparator in First Line Treatment of Locally Advanced or Metastatic Colorectal Cancer

Study start date: February 1, 2004

Inclusion Criteria: The patient must have: * Histologic or cytologic diagnosis of adenocarcinoma of the colon or rectum. * Performance status of 0 to 2 on the ECOG Performance Status Scale. * Standard postoperative adjuvant radiation therapy for rectal cancer is allowed. * Locally advanced or metastatic disease. * Must be 18 years of age. Exclusion Criteria: The patient must not have: * Received prior chemotherapy for advanced disease. Prior adjuvant therapy, including 5-FU, is allowed if it has been more than 12 months since the last treatment. * Received prior treatment with irinotecan in the adjuvant setting. * Are unable to take vitamin B12 or folic acid. * Are unable to interrupt aspirin, other nonsteroidal anti-inflammatory drugs, or COX-2 inhibitors for a 5-day period. * Have a second primary malignancy except carcinoma in situ of the cervix or nonmelanomatous skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence.