A Phase I/II Study of SU011248 (Sutent) in Combination With Irinotecan and Cetuximab as a Second Line Regimen for Patients With Stage IV Colorectal Cancer

Inclusion Criteria:

- Histologic proof of adenocarcinoma of the colon or rectum with evidence of metastatic
disease. The site of the primary lesion must be or have been confirmed
endoscopically, radiologically, or surgically to be or have been in the large bowel

- Patients must have received one (and only one) prior chemotherapy regimen for
metastatic disease using 5-FU/LV or Xeloda in combination with oxaliplatin and
Avastin.

- > 4 weeks must have elapsed from the time of major surgery

- > 2 weeks must have elapsed from the time of minor surgery

- > 4 weeks must have elapsed from the time of major radiotherapy

- Normal organ and marrow function

- Measurable disease be RECIST criteria

- Older than 18 years of age

- ECOG performance status of 0-1

- Life expectancy > 12 weeks

Exclusion Criteria:

- Previous treatment with irinotecan, cetuximab or SU011248

- Any of the following within the 12 months prior to study drug administration:
severe/unstable angina; myocardial infarction; symptomatic congestive heart failure;
cerebrovascular accident; or transient ischemic attack.

- Known brain metastases or carcinomatous meningitis

- Uncontrolled serious medical or psychiatric illness

- NCI CTCAE grade 3 or greater hemorrhage within 4 weeks of starting study treatment

- Uncontrolled hypertension

- Diagnosis of any secondary malignancies with the last 5 years, except for adequately
treated basal cell carcinoma, squamous cell skin cancer, localized prostate cancer
with a normal PSA within the past 3 months, in situ bladder cancer, or in situ
cervical cancer

- Pregnant or breastfeeding

- Concurrent treatment on another clinical trial