- Histologically or cytologically confirmed adenocarcinoma of the colon or rectum with
documented locally advanced or metastatic disease.
- Evidence of unidimensionally measurable disease as defined by the Response Evaluation
Criteria in Solid Tumors (RECIST).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Prior treatment with systemic therapy for locally advanced or metastatic colorectal
- Prior surgery or investigational agent within 4 weeks prior to study entry.
- Pregnancy or breastfeeding. All female patients of reproductive potential must have a
negative pregnancy test (serum or urine) prior to the start of the study.