Study Of Sunitinib In Combination With Folfox In Patients With Colorectal Cancer

• Drug: sunitinib + mFOLFOX6
  
  37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2)
• Drug: sunitinib + mFOLFOX6
  
  50 mg/day, oral, administered on an outpatient basis for 2 weeks on, 2 weeks off (Schedule 2/2)

• Experimental: A
  
  Intervention: Drug: sunitinib + mFOLFOX6
• Experimental: B
  
  Intervention: Drug: sunitinib + mFOLFOX6

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Prior treatment with systemic therapy for locally advanced or metastatic colorectal cancer.
• 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.