A Trial of an Investigational Drug for the Prevention of Diarrhea Associated With Irinotecan/5FU/Leucovorin Chemotherapy in Previously Untreated Metastatic Colorectal Cancer

Other specific inclusion/exclusion criteria may apply. In order to determine eligibility,
further examination by the investigator is necessary.

Inclusion Criteria:

- Age 18 years or older

- Diagnosis of colorectal cancer or adenocarcinoma of the appendix

- A tumor mass that can be measured

- Resolution of all toxic effects of any radiotherapy or surgical procedures to NCI CTC
grade less than or equal to 1

- Willingness and ability to comply with scheduled visits, treatment plan, and
laboratory tests, and other study procedures

Exclusion Criteria:

- Women that are pregnant or lactating

- Prior treatment with Irinotecan

- Partial or complete bowel obstruction, known chronic malabsorption, or total
colectomy or other major abdominal surgery that might result in substantial
alteration in transit or absorption of oral medication

- Administration of the last dose of any previous adjuvant therapy for colorectal
cancer within 6 months previous to randomization

- Current enrollment in another clinical trial

- Administration of any prior systemic anticancer therapy for metastatic colorectal
cancer