Inclusion Criteria

Subjects must fulfill all of the following criteria to be eligible for study entry:

- Signed informed consent

- At least 18 years of age

- Histologically confirmed metastatic colorectal adenocarcinoma of the colon or rectum

Resected or biopsied primary tumors or metastatic site will serve as the basis for
histologic confirmation.

- Measurable disease (defined as at least one dimension >2 cm [>1 cm on spiral CT
scans])

- ECOG performance status of 0 or 1

- Life expectancy >3 months

- Use of an effective means of contraception in men and in women of childbearing
potential

- Ability to comply with study and follow-up procedures