SU011248 in Combination With Irinotecan and Cetuximab as a Second Line Regimen for Stage IV Colorectal Cancer

- Participants will be given a supply of SU011248 capsules to take at home in the morning
for two weeks. After taking the capsules for two weeks, there will be a one-week rest
period.

- Irinotecan will be administered on days 1 and 8 of every 21-day cycle as an intravenous
infusion over 90 minutes. Cetuximab will be administered intravenously on days 1, 8 and
15 of every 21-day cycle. The first treatment of cetuximab is a larger dose. Beginning
with the second treatment, the participant will receive a smaller dose of cetuximab.

- Blood work will be repeated at every clinic visit on days 1 and 8. During cycle 1,
blood will also be drawn on day 15.

- Tumor assessments will be repeated after 6 weeks, 12 weeks, and every 9 weeks
thereafter, and will be assessed by both a CT scan of the abdomen, pelvis, and a chest
x-ray. MUGA scans will be repeated every 4 cycles (12 weeks).

- Participants may continue to receive cycles of study treatment as long as their disease
does not progress and they do not experience any serious side effects.

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